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Active Ingredient: Orlistat.

Alli is used for managing obesity in overweight adults.

Analogs of Alli: Xenical, Orlistat.

Other names for this medication:
Dietil, Fingras, Obelit, Olistat, Orlica, Orlip, Redustat, Reeshape, Tetrahydrolipstatin, Viplena, Vyfat, Xeniplus, Xinplex.

It has long been proven that the key culprit for overweight is a high concentration of fat in food consumed. One gram of fat is 9 kcal, however, and it is simply impossible to completely exclude them from the diet. What to do in a situation where you have to give up tasty and familiar dishes?

The drug Alli, designed to reduce weight, will help to balance the daily diet by blocking the absorption of fatty compounds. The manufacturer claims that this tool will become an assistant in the process of prolonged weight loss.

WHAT DOCTORS SAY ABOUT SLIMMING: Doctor of Medical Sciences…….I have been dealing with weight loss problems for many years. Women often come to me with tears in their eyes, who have tried everything, but the result is either not, or the weight is constantly returning. Previously, I advised them to calm down, go on a diet again and do grueling workouts in the gym. Today there is a better solution – Alli. It can simply be taken as an additive to food, and lose up to 15 kg per month in a completely natural way without diets and physical. loads. This is a completely natural remedy that suits everyone, regardless of gender, age or health.

GlaxoSmithKline, a UK-based pharmaceutical company in the United Kingdom, has been manufacturing Alli medicines, which are allowed to be released without a medical prescription, since 2006. The developers advise using the drug for people who are overweight or on the verge of obesity – the Quetelet index should be at least 25 (body mass index).

Capsules for weight loss Alli is difficult to attribute to the category of “magic”, rather it is a drug that can increase the effectiveness of diet food. The manufacturer honestly declares that you should not expect miracles from the use of Alli – you should adjust your lifestyle, and the capsules will enhance the effect of losing weight.

Enough to cheat yourself
Before reading further, I will ask you 1 question. Are you still looking for a working diet or magic diet pill?

COMPONENTS

The main component of the Alli preparation is the substance orlistat, the content of which is 60 mg. Due to this concentration, the drug has the most delicate effect on the body and can be realized without a doctor’s prescription.

The main components of Alli:

  • Orlistat – 60 mg;
  • Coloring components E171 (titanium dioxide) and E132 (indigo carmine);
  • Opacode;
  • Iron oxide (E172);
  • Propylene glycol;
  • Isopropyl alcohol;
  • Ammonium hydroxide;
  • N-butyl alcohol.

A potential buyer, for sure, will be alerted by such an amount of chemical compounds in one capsule of the drug. Indeed, for what purpose is a tool designed to help the body in the process of losing weight, excess chemistry and how will it affect health in general?

PHARMACOKINETICS
The active component of the drug has a blocking effect on lipases – enzymes that break down fat molecules in the gastrointestinal tract. Due to this, the decomposition of complex fats into monoglycerides and fatty acids is stopped, which, as a result, are not absorbed, but are eliminated from the intestine in the initial state. Against the background of exposure to orlistat, the body has a negative calorie content, which reduces the amount of its own adipose tissue.
The recommended dose of the drug is active without systemic effects on the body as a whole. Studies conducted by the British clinical laboratory indicate that the drug does not adversely affect the characteristics of bile, the level of acidity of the gastric juice, and the speed of the lump of food moving along the digestive tract.
Long-term use of Alli can affect the balance in the body of elements such as iron, copper, magnesium, zinc, phosphorus and calcium.

After 18 – 36 hours from the time of the use of the drug in the stool, an increase in fat is observed. Cancel Alli reduces the concentration of fat in feces after 2 to 4 days.

PHARMACODYNAMICS
Alli weight loss product is considered a lipase inhibitor. It differs in similarity with the structure of triglycerides, therefore, it binds to them, providing a change in absorption of 30% of these components. Constant intake of the drug guarantees persistent weight loss.

It is characterized by increased selectivity, therefore, does not affect the mechanism of splitting and absorption of proteins and carbohydrates. To a small extent, the process of absorption of fat-soluble vitamins changes, however, discontinuation of the drug leads to the restoration of lipase activity.

APPLICATION ALGORITHM
The drug is intended for use exclusively by mature buyers. Dosage for adults is: 1 capsule three times a day (60 mg) during the main meals against a low-calorie diet with a moderate fat content.

Alli can be taken immediately before meals, with meals or no later than 40 minutes after the meal. Or a meal is skipped or the dish does not contain a large amount of fat, then the use of the drug is excluded.

It is necessary to take the Alli slimming product only in recommended therapeutic doses, that is, no more than three times during the day.

The duration of continuous use of the drug is no more than six months.
The achieved intermediate results of using Alli should be discussed with your doctor. In the event that during the three-month use of the product there are no qualitative changes in body weight, you should consult with a specialist regarding the continued use of Alli capsules.

ADVERSE EVENTS
Clinical studies of orlistat action by an independent laboratory have established negative reactions from the side, mainly the gastrointestinal tract, which appear at the beginning of drug use and are considered reversible. Experts note that responsible dieting will reduce the likelihood of adverse reactions. The list of negative manifestations:

FROM THE DIGESTIVE BODIES
 – Oily feces;
  – Imperative urge to act defecation;
  – Flatulence;
  – Steatorrhea (excess fat in feces);
  – Soreness in the stomach;
  – Loose stools;
  – Rapid urge to defecate or fecal incontinence.
The listed phenomena are transient and weakly expressed.
As a rule, they occur in the early stages of the use of Alli (in the first 1-3 months) and most patients noted no more than one episode of such manifestations.

FROM THE BLOOD SYSTEM
  Decreased prothrombin level;
  Increased prothrombin levels in patients taking alli with indirect coagulants.

FROM THE SKIN
– Hives;
  – Bullous rashes;
  – Peeling.

ON THE LIVER
  – The formation of stones in the gallbladder;
  – Hepatitis;
  – Increased alkaline phosphatase;
  – Increased levels of hepatic transaminases.

FROM THE IMMUNE SYSTEM
  – Hypersensitivity to the components of the drug;
  – Itching, rashes of a different nature and localization;
  – Bronchospasm;
  – Angioedema; anaphylactic shock.

RESTRICTIONS FOR USE
Based on an extensive list of adverse reactions, it is easy to guess that not everyone is allowed to use the drug. Of course, for medical reasons it is categorically contraindicated in women bearing a child, as well as in nursing mothers.

Restrictions on the use are:

– Patients under the age of 18 and over 60;
– Hypertension of varying severity;
– Intestinal pathology;
– Diabetes;
– A history of allergic reactions;
– Heart rhythm disturbance;
– Chronic diseases of the kidneys and urinary tract;
– Pathology of the thyroid gland;
– Atherosclerosis of blood vessels;
– Past strokes and heart attacks.

Despite the fact that the drug for weight loss Alli is available for sale without a prescription, it belongs to the list of medical products.
This fact requires the buyer to pre-study the instructions for use and, even with minor doubts, choose an alternative way to lose weight.

TESTIMONIALS
It is important to note that the opinions of those who are losing weight regarding the Alli drug are divided. Patients satisfied with the action of the drug report that, thanks to it and proper nutrition, they were able to painlessly throw at least 10 kilograms. Further, the weight decreases not so rapidly, however, the tendency to lose weight is not reduced.

Patients dissatisfied with the use of Alli, say that, at best, the drug did not cause absolutely any positive results. At worst, the drug provoked the occurrence of side effects associated with impaired intestinal tract activity. It is noteworthy that such reviews can be heard from patients weighing 100 kilograms or more.

Extra kilograms accumulate over the years, and sometimes decades, so it’s impossible to quickly get rid of them. The process of persistent weight loss requires an integrated approach over a long period of time. In any case, it is recommended to fight overweight under the supervision of a specialist – this will ensure the selection of the right weight loss program and get a guaranteed effect.

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Active Ingredient: Nevirapine
VIRAMUNE (Nevirapine) is used in the treatment of infection with the HIV virus (the virus that causes AIDS).

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Other names for this medication:
Filide, Flaminev, Nerapin, Nevimune, Nevipan, Nevir, Nevirapin, Nevirapina, Névirapine, Nevirapinum, Nevirapinum anhydricum, Nevirapox, Nivepin, Niverin, Protease, Ritvir, Virainhi.

Pharmacodynamics:

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of type 1 human immunodeficiency virus (HIV-1). Nevirapine directly binds to reverse transcriptase and blocks the activity of RNA-dependent and DNA-dependent DNA polymerase, causing the destruction of the active center of this enzyme. Nevirapine does not compete with matrix triphosphates or nucleoside triphosphates. Nevirapine does not inhibit HIV-2 reverse transcriptase and eukaryotic cell DNA polymerase (such as human DNA polymerase α, β, γ or σ).

Nevirapine should not be used as monotherapy for the treatment of HIV infection or added as the only drug to the treatment regimen that has been found to be ineffective. When nevirapine is used as monotherapy, virus resistance rapidly develops, which is also characteristic of all other non-nucleoside reverse transcriptase inhibitors.

When choosing new antiretroviral drugs that are supposed to be used in combination with nevirapine, data on the possibility of developing cross-resistance should be taken into account.

When canceling an antiretroviral therapy regimen containing nevirapine, it is necessary to take into account the long half-life of this drug. If antiretroviral drugs with shorter half-lives than nevirapine are stopped at the same time, then due to the low concentration of nevirapine that lasts for a week or more, resistance to HIV may develop.

Pharmacodynamics:

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of type 1 human immunodeficiency virus (HIV-1). Nevirapine directly binds to reverse transcriptase and blocks the activity of RNA-dependent and DNA-dependent DNA polymerase, causing the destruction of the active center of this enzyme. Nevirapine does not compete with matrix triphosphates or nucleoside triphosphates. Nevirapine does not inhibit HIV-2 reverse transcriptase and eukaryotic cell DNA polymerase (such as human DNA polymerase α, β, γ or σ).

Nevirapine should not be used as monotherapy for the treatment of HIV infection or added as the only drug to the treatment regimen that has been found to be ineffective. When nevirapine is used as monotherapy, virus resistance rapidly develops, which is also characteristic of all other non-nucleoside reverse transcriptase inhibitors.

When choosing new antiretroviral drugs that are supposed to be used in combination with nevirapine, data on the possibility of developing cross-resistance should be taken into account.

When canceling an antiretroviral therapy regimen containing nevirapine, it is necessary to take into account the long half-life of this drug. If antiretroviral drugs with shorter half-lives than nevirapine are stopped at the same time, then due to the low concentration of nevirapine that lasts for a week or more, resistance to HIV may develop.

Pharmacokinetics:

Adults
Nevirapine is well absorbed (> 90%) when taken orally. The absolute bioavailability after applying a single dose of the drug is 50 mg for tablets – 93 ± 9% and for oral solution – 91 ± 8%. The maximum concentration (Cmax) of nevirapine in plasma after a single dose of the drug at a dose of 200 mg was determined after 4 hours and was 2 ± 0.4 μg / ml (7.5 μmol). After taking the drug repeatedly in doses from 200 to 400 mg / day, the maximum concentration (Cmax) of nevirapine increased linearly depending on the dose. The equilibrium concentration when taking the drug at a dose of 400 mg / day was 4.5 ± 1.9 μg / ml (17 ± 7 μmol).

Nevirapine has a high lipophilicity and practically does not ionize at physiological pH. After intravenous administration to healthy adult volunteers, the equilibrium volume of nevirapine distribution (Vdss) was 1.21 ± 0.09 L / kg, which indicates a wide distribution of the drug in the tissues. Nevirapine penetrates well through the placental barrier and is determined in breast milk. The binding of nevirapine to plasma proteins is about 60%, its concentration in plasma varies from 1 to 10 μg / ml. The concentration of nevirapine in the cerebrospinal fluid in humans is 45% (± 5%) of plasma; this ratio approximately corresponds to the fraction of the drug unbound with plasma proteins. Nevirapine metabolism is carried out mainly with the help of cytochrome P450 isoenzymes from the CYP3A family of isoenzymes; other isoenzymes can also play an additional role. Nevirapine is biotransformed to several hydroxyl metabolites.

When a single dose (50 mg) of isotope-labeled nevirapine 14C was administered against the background of a steady state of pharmacokinetics, approximately 91.4 ± 10.5% of the isotope-labeled dose of the drug was excreted, mainly (81.3 ± 11.1%), by the kidneys and, to a lesser extent ( 10.1 ± 1.5%), intestines.

More than 80% of 14C-nevirapine found in urine was associated with hydroxylated metabolites of glucuronide conjugates. Thus, the main pathway for biotransformation and excretion of nevirapine in humans is through metabolism involving cytochrome P450 isoenzymes, conjugation with glucuronides, and excretion of metabolites associated with glucuronides and kidneys. Only a small fraction, less than 5%, of 14C-nevirapine (corresponding to <3% of the total dose) was excreted by the kidneys in an unchanged state.

Nevirapine is an inducer of cytochrome GM50 isoenzymes in the liver. If after taking a single dose the treatment lasts for 2-4 weeks (200-400 mg / day), the pharmacokinetics are characterized by auto-induction: the clearance of nevirapine after oral administration increases by about 1.5-2 times. Autoinduction also leads to a corresponding reduction in the half-life of nevirapine: from about 45 hours (after a single dose) to about 25-30 hours (after multiple doses of the drug in doses of 200-400 mg / day).

Floor
Nevirapine clearance in women is 13.8% less than in men. This difference is not considered clinically significant.

Renal failure
Renal failure (mild – creatinine clearance of 50 – 80 ml / min, moderate – creatinine clearance of 30 – 50 ml / min or severe – creatinine clearance of less than 30 ml / min) does not lead to significant changes in the pharmacokinetics of nevirapine. However, in patients with end-stage renal failure requiring dialysis, there was a decrease in the area under the concentration-time curve (AUC) by 43.5% and the accumulation of hydroxylated nevirapine metabolites in plasma, therefore, adult patients are recommended adjuvant therapy with nevirapine after each a dialysis session of an additional dose of 200 mg, which compensates for the effect of dialysis on the clearance of the drug.

Liver failure
VIRAMUNE should not be used in patients with severely impaired hepatic function (Child-Pugh class C).

Patients with mild to moderate impaired liver function do not need dose selection, but such patients need careful monitoring in order to register adverse drug reactions.

Children (children from 3 months to 16 years old participated in clinical trials)
Nevirapine, used in doses of 4/7 mg / kg and 150 mg / m2, was effective and safe for use in children who had not previously received antiretroviral therapy. When using both dosing regimens, a significant increase in the percentage of CD4 + cells was observed by 48 weeks. Both dosing regimens also effectively reduced the viral load.

After oral administration of nevirapine, the clearance of the drug in children increased with the age of the patients, which coincided with an increase in body surface area. The average basal concentration of nevirapine after using the drug at a dose of 150 mg / m2 twice a day (following a two-week introductory period of taking the drug at a dose of 150 mg / m2 once a day) was 4-6 μg / ml (which is consistent with adult data )

Newborns
In newborns (born to HIV-1-infected mothers who received 200 mg of nevirapine once during childbirth) after applying a suspension of nevirapine at a dose of 2 μg / kg for 72 hours after birth, the half-life of nevirapine was 47 hours. The plasma nevirapine concentration during the first week of life was more than 100 ng / ml.

In children under the age of 3 months, the concentration of nevirapine coincided with the concentration established in adults and in children of a different age, but differed in greater variability, especially in children of the second month of life.

Indications:
Treatment of HIV-1 infection as part of combination antiretroviral therapy.

To prevent the transmission of HIV-1 from mother to child, in women who do not receive antiretroviral therapy during childbirth, VIRAMUNE is indicated and can be used in the mother as monotherapy, as a single dose, taken orally during childbirth, and in the child, in the form of a single dose used after birth.

Contraindications:

  • Hypersensitivity to the active component or any other component of the drug.
  • VIRAMUNE should not be reassigned to patients who had previously, during the treatment with nevirapine, required its withdrawal due to severe rash, hypersensitivity reactions or the development of clinically pronounced hepatitis caused by the drug.
  • Severe hepatic impairment (Child-Pugh class C) or cases of an initial increase in the activity of aspartate aminotransferase (ACT) or alanine aminotransferase (ALT), more than 5 times the upper limit of normal (until the activity of AST / ALT decreases steadily to a level less than 5 times the upper limit of the norm). VIRAMUNE should not be reassigned to patients who have previously noted an increase in ACT or ALT activity to a level more than 5 times the upper limit of normal, or to patients in whom, after repeated use of nevirapine, there has been a resumption of liver dysfunction.
  • During the administration of nevirapine, herbal preparations containing Hypericum perforatum perforatum extract should not be used, due to the risk of a decrease in plasma nevirapine concentration and a decrease in its clinical effect.
  • VIRAMUNE is not recommended for use with efavirenz, rifampicin, ketoconazole, delavirdine, etravirine, rilpivirin, elvitegravir (together with cobicistat), boceprevir; as well as with fosamprenavir, saquinavir, atazanavir (in the case when they are used together with a low dose of ritonavir).
  • Patients with rare hereditary disorders (fructose intolerance, pnosis-galactose malabsorption, sucrose-isomaltase deficiency) should not take VIRAMUNE as a suspension, since the maximum recommended daily dose contains 6 g of sucrose and 6.5 g of sorbitol.

1 1

Carefully:

Mild to moderate liver failure
Simultaneous therapy with telaprevir, rifabutin, warfarin, methadone, lopinavir / ritonavir, clarithromycin, fluconazole, itraconazole, ethinlestradiol, indinavir.

Pregnancy and lactation:
The safety and effectiveness of the drug VIRAMUNE, which is used to prevent the transmission of HIV-1 from mother to child, has been established for oral administration of the drug once by 200 mg by the mother during childbirth.

Adequate and well-controlled studies of the therapy of HIV-1-infected pregnant women have not been conducted.

VIRAMUNE should be used during pregnancy only in cases where the possible benefits to the mother outweigh the potential risk to the fetus.

Pregnant women
Studies have shown that during childbirth in HIV-1-infected women, the half-life of VIRAMUNE, after a single oral dose of 200 mg, is prolonged (up to 60-70 hours), and the clearance varies significantly (2.1 ± 1 5 l / h), which depends on the degree of physiological stress during childbirth. Nevirapine rapidly crosses the placental barrier. The concentration of nevirapine in the blood of the umbilical cord after the mother took a dose of 200 mg, exceeded 100 ng / ml, and the ratio of the concentrations in the blood of the umbilical cord and in the mother’s blood was 0.84 ± 0.19.

Breastfeeding mothers
HIV-infected mothers should not breast-feed newborns in order to avoid the risk of postnatal transmission of HIV. Mothers who receive VIRAMUNE should refuse to breast-feed, because the drug is determined in breast milk.

Dosage and administration:
Inside. Shake the bottle before use.

VIRAMUNE may be taken without regard to meals.

The drug should be taken only in combination with at least two additional antiretroviral drugs, with the exception of the case of the drug to prevent the transmission of HIV-1 from mother to child once, during childbirth, or, within 72 hours after birth, in the newborn.

To reduce the incidence of skin rash, adults and children should take only one dose of the drug per day for the first 14 days (“introductory period”). If a skin rash develops during this period, then you should immediately consult a doctor for advice and do not increase the dose.

Adults:
200 mg once daily for the first 14 days, then the usual dose of 200 mg twice daily should be taken.

Children:
The total daily dose should not exceed 400 mg. VIRAMUNE can be dosed in children, either taking into account body surface area (PPT), or taking into account body weight.

When taking into account body surface area using the Mosteller formula, the recommended dose for oral administration in children of any age is 150 mg / m2 once a day for 14 days, then 150 mg / m2 twice a day.

When taking into account body weight, the recommended dose for oral administration in children under 8 years of age is 4 mg / kg once a day for 14 days, then 7 mg / kg twice a day. In children 8 years of age and older, 4 mg / kg once a day for 14 days, then 4 mg / kg twice a day.

General recommendations. VIRAMUNE should be taken daily according to the instructions for use. If you skip taking the drug, you should not double the next dose, but you need to take the next dose as soon as possible.

Before taking the drug and at appropriate intervals during the course of therapy, biochemical blood tests should be performed, including studies of liver function.

Patients who have a skin rash during a 14-day introductory period of a daily dose of 200 mg per day should not increase the dose until the rash disappears. The dosage regimen using 200 mg of the drug once a day should not last more than 28 days, then it is necessary to choose alternative methods of therapy.

Patients who discontinued the use of the drug VIRAMUNE for a period of more than 7 days, when resuming therapy, should again repeat the recommended regimen, using a two-week induction period.

Prevention of mother-to-child transmission of HIV
The following dosage regimen is recommended for pregnant women and their newborns:
Pregnant: 200 mg as soon as possible after the onset of labor. Newborns: 2 mg / kg once within 72 hours after birth. If the mother received VIRAMUNE less than two hours before delivery, the newborn should be given the first dose (2 mg / kg) immediately after birth, and the second dose (2 mg / kg) within 24-72 hours after the first.

Patients with impaired renal function
For adult patients with end-stage renal failure (creatinine clearance less than 20 ml / min) requiring dialysis, adjuvant therapy with nevirapine is recommended with an additional dose of 200 mg after each dialysis session. Patients whose creatinine clearance is more than 20 ml / min do not require dose adjustment of nevirapine.

Children undergoing hemodialysis are advised to take nevirapine adjuvant therapy with an additional dose of 50% of the recommended daily dose after each dialysis session, which compensates for the effect of dialysis on the clearance of the drug.

Patients with impaired liver function
Patients with mild to moderate hepatic impairment are not required to select a dose, but such patients need careful monitoring in order to register adverse drug reactions.

Side effects:
On the part of the blood and lymphatic system:
Granulocytogenesis, anemia.

From the immune system:
Drug reaction accompanied by eosinophilia and systemic symptoms, anaphylactic reaction, hypersensitivity (including anaphylactic reaction, angioedema, urticaria).

From the nervous system:
Headache.

From the gastrointestinal tract:
Diarrhea, abdominal pain, nausea, vomiting.

On the part of the liver and biliary tract:
Hepatitis (including serious and life-threatening hepatogoxicity), fulminant hepatitis (which can lead to death), jaundice.

On the part of the skin and subcutaneous tissue:
Skin rash, Stevens-Johnson syndrome / toxic epidermal necrolysis (which can lead to death), angioedema, urticaria.

From the musculoskeletal system and connective tissue:
Arthralgia, myalgia.

Influence on the results of laboratory and instrumental studies: impaired liver function tests (increased activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase and hyperbilirubinemia), decreased blood phosphorus, increased blood pressure.

Other:
Pyrexia, fatigue.

In the prevention of vertical transmission of HIV infection, a low incidence of adverse events was observed. Serious dermatological or hepatologic reactions, which would be regarded as associated with taking the drug, were not observed. Post-marketing experience: severe hepatitis, liver failure, kidney damage. Against the background of combined antiretroviral therapy, a redistribution of subcutaneous tissue was noted (thinning of the subcutaneous tissue of the face and limbs and an increase in subcutaneous tissue in the abdomen, internal organs, chest and abdomen, breast hypertrophy); hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactatemia; pancreatitis, peripheral neuropathy, thrombocytopenia; immunity restoration syndrome; osteonecrosis.

Overdose:
Cases of overdose with VIRAMUNE have been reported (intake from 800 to 6000 mg per day for up to 15 days). Symptoms: edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, lung infiltrates, rash, dizziness, vomiting, increased activity of hepatic transaminases and weight loss.

Interaction:
It has been shown that VIRAMUNE is an inducer of liver cytochrome P450 isoenzymes (CYP3A, CYP2B6) and can lead to a decrease in the plasma concentration of other simultaneously used drugs that are intensively metabolized by CYP3A or CYP2B6 isoenzymes. Therefore, if a patient who previously had a dosing regimen selected for a drug metabolized by the CYP3A or CYP2B6 isoenzyme begins treatment with nevirapine, it may be necessary to adjust the dose of this drug. Maximum induction is observed within 2-4 weeks after initiation of therapy.

Antiretroviral drugs:
NRTI (Nucpeoside analogues of reverse transcriptase inhibitors)

  • When using VIRAMUNE in combination with didanosine (at a dose of 100-150 mg twice a day), dose adjustment is not required.
  • When using VIRAMUNE in combination with emtricitabn and abacovir, which are not inhibitors of cytochrome P450 isoenzymes, dose adjustment is not required.
  • When using VIRAMUNE in combination with lamivudine (at a dose of 150 mg twice a day), dose adjustment is not required.
  • When using VIRAMUNE in combination with stavudine (30 – 40 mg twice a day), dose adjustment is not required.
  • When using VIRAMUNE in combination with tenofovir (300 mg once a day) and zidovudine (100 – 200 mg three times a day), which do not affect the pharmacokinetics of nevirapine; dose adjustment is not required.
  • When using VIRAMUNE in combination with zalcitabine (0.125 – 0.25 mg three times a day), dose adjustment is not required.

Non-nucleoside analogues of reverse transcriptase inhibitors
The simultaneous use of efavirenza (600 mg per day) and nevirapine is not recommended, because this combination may increase the risk of adverse reactions resulting in cumulation of toxicity. In addition, this combination does not increase effectiveness compared with monotherapy with non-nucleoside analogues of reverse transcriptase inhibitors (there is a decrease in AUC, Cmin and Cmax efavirenza).

The simultaneous use of nevirapine with delavirdine and rilpivirin is not recommended (since the combined use of these drugs has not been studied); the combined use of nevirapine with etravirine is not recommended, since the combined use of these drugs can lead to a significant decrease in the concentration of etravirine in the plasma and a decrease in its effectiveness.

PI (Protease Inhibitors)
When using atazanavir in combination with nevirapine, atazanavir should be prescribed in a dose of 400 mg along with ritonavir in a low dose of 100 mg. When using this combination (nevirapine with atazanavir / ritonavir at a dose of 400/100 mg 2 times a day), there is a decrease in AUC, Cmin, Cmax of atazanavir and an increase in AUC, Cmin, Cmax of nevirapine.

While taking nevirapine with darunavir / ritonavir (400/100 mg 2 times a day), darupavir / ritonavir inhibits CYP3A4 and thus increases the concentration of nevirapine. Since a change in nevirapine concentration is not considered clinically significant, dose adjustment is not required.

With the simultaneous administration of nevirapine with fosamprenavir / ritonavir (700/100 mg 2 times a day), a dose change is not required.

VIRAMUNE should not be used with fosamprsnavir (at a dose of 1400 mg 2 times a day) if ritonavir is not used simultaneously with them.

With the simultaneous administration of nevirapine with nelfinavir (750 mg 3 times a day), there are no clinically significant changes in the pharmacokinetics of nevirapine and nelfinavir, therefore, dose adjustment is not required.

With the simultaneous administration of nevirapine with ritonavir (600 mg 2 times a day), the plasma concentrations of nevirapine and ritonavir are not significantly changed, dose adjustment is not required.

With the simultaneous administration of nevirapine with saquinavir / ritonavir, a dose change is not required.

VIRAMUNE should not be used with saquinavir (at a dose of 600 mg 3 times a day) if ritonavir is not used simultaneously.

With the simultaneous administration of nevirapine with tipranavir / ritonavir (500/200 mg 2 times a day), clinically significant pharmacokinetic changes are not expected, dose adjustment is not required.

With regard to the potential consequences of the combined use of nevirapine and indinavir (at a dose of 800 mg every 8 hours), certain clinical findings have been made. Clinical data on the interaction of nevirapine with indinavir / ritonavir are limited.

While taking nevirapine with lopinavir / ritonavir, it is recommended that the dose of lopinavir / ritoyavir be increased to 533/133 mg (4 capsules) twice a day with meals.

HIV and cell fusion inhibitors
Clinically significant pharmacokinetic interactions between enfuvirtide and concomitantly used drugs metabolized by CYP450 isoenzymes are not expected. With the simultaneous use of enfuvirtide with nevirapine, dose changes are not required.

With the simultaneous use of maraviroc (at a dose of 300 mg once a day) with nevirapine, dose adjustment is not required.

Integrase inhibitors
With the combined use of raltegravir (at a dose of 400 mg 2 times a day) with nevirapine, dose changes are not required.

The combined use of nevirapine and elvitegravir (in combination with cobicistat) is not recommended. Cobicistat is an inhibitor of cytochrome P450 ZA, so the combined use is likely to lead to a change in the concentration of cobicistat and nevirapine in the plasma.

Antiviral drugs for the treatment of hepatitis B and C
Interferons (pegylated interferons alpha-2a and alpha-2b) do not affect the isoenzymes of CYP ZA4 and CYP 2B6. Clinically significant interactions between interferons and nevirapine are not expected. No dose changes are required.

Entecavir is not a substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (CYP450). Clinically significant interactions between entecavir and nevirapine are not expected. No dose changes are required.

Telbivudine is not a substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (CYP450). Clinically significant interactions between telbivurdine and nevirapine are not expected. No dose changes are required.

In vitro studies have shown that there is little antagonism between nevirapine and adefovir. However, this has not been confirmed in clinical studies, therefore, a decrease in the effectiveness of nevirapine and adefovir with their combined use is not expected. Adefovir does not affect known CYP isoenzymes. Dose changes with the combined use of adefovir and nevirapine ns are required.

In vitro studies have shown that there is little antagonism between nevirapine and ribavirin. However, this ns has been confirmed in clinical studies, therefore, a decrease in effectiveness with the combined use of nevirapine and ribavirin is not expected. Ribavirin does not affect the cytochrome P450 isoenzymes. Dose changes with the combined use of nevirapine and ribavirin are not required.

Boceprevir is partially metabolized by isoenzymes CYP3A4 and CYP3A5. The combined use of boceprevir with NNRTIs, in which the metabolic pathway is the same as nevirapine, reduced the basal concentration of boceprevir. The clinical outcome of a decrease in basal concentration of boceprevir is unknown. The combined use of nevirapine and boceprevir is not recommended.

Telaprevir is metabolized in the liver with the participation of the CYP3A isoenzyme and is a substrate for glycoprotein-P. Other isoenzymes can also participate in the metabolism of the drug. The combined use of telaprevir and drugs that induce the CYP3A isoenzyme and / or glycoprotein-P can lead to a decrease in plasma telaprevir concentration. Studies of the interactions of telaprevnr with nevirapine have not been conducted, but studies of the interaction of telaprevir with NNRTIs, which have the same metabolic pathway as nevirapine, have shown that the concentrations of both drugs are reduced. Caution should be exercised when the combined use of nevirapine and telaprevir, since a dose change of telaprevir may be required.

Antibiotics
With the simultaneous use of nevirapine and clarithromycin (500 mg 2 times a day), dose adjustment of any of these drugs is not required. Nevertheless, careful monitoring of liver function is necessary.

When treating patients with infections caused by mycobacterium avium-intracellularc complex, alternative clarithromycin therapy should be taken into account, since the active metabolite of the drug is ineffective in this case.

With the simultaneous use of rifabutin (150 – 300 mg once a day) and nevirapine, a dose change is not required. Due to the high interindividual variability in some patients, the risk of rifabutin toxicity may increase. Therefore, when used together, care must be taken.

VIRAMUNE should not be used in combination with rifampicin (600 mg once daily). Clinical evidence of the need for dose adjustment of nevirapine with concomitant use with rifampicin is limited. If it is necessary to treat patients with tuberculosis and apply a therapy regimen including VIRAMUNE, an alternative drug rifabutin should be used.

Erythromycin significantly inhibits the formation of hydroxylated nevirapine metabolites.

Antifungal drugs
Due to a 2-fold increase in AUC, Cmin and Cmax of nevirapine, with the simultaneous use of nevirapine with fluconazole (200 mg 1 time per day), caution should be exercised and careful monitoring of the patient’s condition should be carried out.

With the simultaneous use of nevirapine with itraconazole (200 mg / day), an increase in the dose of the latter may be required.

Ketocopazole and nevirapine should not be used together, since ketoconazole significantly inhibits the formation of hydroxylated metabolites of nevirapine.

Antacids
With the simultaneous use of cimetidine and nevirapine, changes in the dose of ns are required. The ingestion of food, antacids and drugs with an alkaline buffer medium does not affect the absorption of nevirapine.

Antithrombotic agents
The interaction between nevirapine and the antithrombotic drug warfarin is complex, while the simultaneous use of these drugs there is the possibility of both increasing, reducing and reducing blood coagulation time.

During the first weeks of simultaneous use and after discontinuation of the drug VIRAMUNE, the final result of the interaction may change, so careful monitoring of the parameters of the blood coagulation system is advisable.

Contraceptives
With the simultaneous use of nevirapine with medrokeiprogesterone (depot form, 150 mg every 3 months), dose changes are not required. The simultaneous use of the drug VIRAMUNE does not violate the suppressive effect of medroxyprogesterone on ovulation. Oral hormonal contraceptives (e.g. ethinyl estradiol, 0.035 mg) should not be used as the only method of contraception in women taking VIRAMUNE. Adequate doses for hormonal contraceptives (oral or other dosage forms), except medroxyprogesterone, for combination with the drug VIRAMUNE have not been established with regard to safety and effectiveness.

Analgesics / Opioids
In patients receiving both VIRAMUNE and methadone, withdrawal syndrome was reported. Patients receiving maintenance doses of methadone and starting nevirapine therapy should be monitored for signs of withdrawal syndrome and the need for a corresponding change in methadone dose in these cases.

Herbal preparations
Herbal preparations containing St. John’s wort (Hypericum perforatum) extract should not be used with nevirapine. If the patient is already taking these drugs, you should check the concentration of nevirapine and, if possible, the concentration of the virus, and stop using preparations containing St. John’s wort herb extract. After their withdrawal, the concentration of nevirapine may increase. You may need to change the dose of VIRAMUNE. After discontinuation of preparations containing St. John’s wort herb extract, the inductive effect may persist for at least 2 weeks.

Special instructions:
With monotherapy with VIRAMUNE, resistant strains of the virus quickly and almost always arise. Therefore, VIRAMUNE should always be used in combination with at least two other antiretroviral drugs, with the exception of the case of using the drug to prevent mother-to-child transmission of HIV-1 once, during childbirth and in the newborn within 72 hours after birth.

The first 18 weeks of therapy are important. During this period, careful monitoring of patients is required to identify possible severe and life-threatening skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), hepatitis, or liver failure.

The greatest risk of hepatological and dermatological reactions exists in the first 6 weeks of therapy. However, the risk of adverse reactions from the liver remains in the future, so the need for monitoring remains.

The risk of adverse events from the liver is increased in patients with a higher number of CD4 + cells at the beginning of therapy. Given the pronounced and life-threatening gspatotoxicity, VIRAMUNE ns should be prescribed to women with a CD4 + lymphocyte count of more than 250 in 1 mm3, and men with a CD4 + lymphocyte count of more than 400 in 1 mm3, in whom HIV-1 RNA is determined in plasma, if only the use of the drug Does not exceed the risk of side effects.

In some cases, impaired liver function may persist even after discontinuation of the drug.

In the case of signs or symptoms of hepatitis, serious skin reactions or hypersensitivity reactions, patients should stop taking the drug and immediately contact a medical institution for examination.

VIRAMUNE should not be reassigned to patients in whom, when taking this drug, severe reactions from the liver, skin, or hypersensitivity reactions were previously observed.

Monotherapy with VIRAMUNE is accompanied by the development of resistance to non-nucleoside analogues of reverse transcriptase inhibitors. In women who have previously received a single dose of VIRAMUNE in order to prevent the transmission of HIV-1 from mother to child, the effectiveness of VIRAMUNE, which is used as part of combination therapy, may be reduced. In cases where other antiretroviral drugs are available, the single-dose VIRAMUNE therapy regimen should be combined with additional effective antiretroviral drugs (in accordance with existing international recommendations).
It is necessary to strictly adhere to the recommended dosage regimen.

Skin reactions:
VIRAMUNE should be canceled in any patient in case of severe rash or rash, accompanied by common symptoms (fever, blistering, changes in the oral mucosa, conjunctivitis, swelling of the face, pain in joints and muscles, general malaise), with Stevens-Johnson syndrome or toxic epidermal necrolysis. VIRAMUNE should be canceled and should not be prescribed again in any patient in case of hypersensitivity reactions characterized by a rash and general symptoms of damage to internal organs, such as hepatitis, eosinophilia, granulocygopenia and impaired renal function, as well as in case of other changes in the function of internal organs.

Patients should be informed that the main manifestation of the toxicity of the drug VIRAMUNE is a rash. To reduce the incidence of a rash, an introductory initial treatment period should be used. In most cases, a rash associated with taking the drug occurs in the first six weeks of therapy, therefore it is during this period that careful monitoring of patients regarding dermatological reactions is necessary. Patients should be informed that if any rash develops during the initial introductory period of treatment, the dose should not be increased up to two times a day until the rash disappears. The dosage regimen using 200 mg of the drug once a day should not last more than 28 days, at this point in time another regimen should be developed.

In rare cases, in patients with skin and liver reactions associated with the use of nevirapine, rhabdomyolysis was observed.

It was shown that the simultaneous use of prednisone (40 mg / day, during the first 14 days of taking nevirapine) does not reduce the incidence of a rash, but, on the contrary, can increase the frequency of dermatological reactions during the first 6 weeks of therapy.
Among the risk factors for developing serious skin reactions is a violation of the recommendation on the use of the drug at a dose of 200 mg per day during the initial initial treatment period. The risk of serious complications of dermatological reactions increases if procrastination is delayed after seeking symptoms after the onset of symptoms. The risk of developing a rash in women is higher than in men, both in the case of nevirapine and in the case of therapy that does not contain nevirapine.

Reactions from the liver:
It is necessary to inform the patient that reactions from the liver are the main manifestation of the toxicity of the drug VIRAMUNE. Patients who have symptoms of hepatitis should stop taking the drug and immediately contact a medical institution for examination, which should include an assessment of liver function.

Postexposure prophylaxis for people who have not been infected with HIV is not one of the approved indications for the use of the drug and therefore is strictly not recommended. With repeated use of the drug VIRAMUNE for the purpose of postexposure prophylaxis of persons who were not infected with HIV, severe manifestations of hepatotoxicity were reported, including about the development of liver failure requiring liver transplantation.

A high risk of adverse reactions from the liver during any antiretroviral therapy (including during therapy involving nevirapine) is noted with an initial increase in the activity of ACT or ALT enzymes by more than 2.5 times compared with the upper limit of normal, and / or in the presence of hepatitis B and / or C.

Liver monitoring
An asymptomatic increase in the activity of liver enzymes and gamma-glutamyltransferase (GGT) is often described and ns is an absolute contraindication for the use of VIRAMUNE. Strict monitoring of liver function indicators is recommended at short intervals, depending on the clinical condition of the patient, especially during the first 18 weeks of treatment. Clinical and laboratory monitoring should continue throughout the treatment period. Doctors and patients should be wary of prodromal signs or symptoms of hepatitis such as anorexia, nausea, jaundice, bilirubinemia, fecal discoloration, hepatomegaly, or liver soreness. Patients should be informed of the need to seek medical advice in such cases. In the case of increased activity of ACT or ALT enzymes more than 2.5 higher than the upper limit of normal before or during treatment, liver function indicators should be monitored more often during regular examinations. VIRAMUNE should not be prescribed to patients in whom the initial activity of ACT or ALT is more than 5 times higher than the upper limit of normal (until it stably decreases to a level of less than 5 times higher than the upper limit of normal). If the activity of ACT or ALT enzymes increases by more than 5 times compared with the upper limit of normal during treatment, VIRAMUNE should be immediately canceled. If the activity of the enzymes ACT and ALT returns to the initial values ​​and if the patient does not have any symptoms of hepatitis or general symptoms or other phenomena indicating impaired function of the internal organs, the use of the drug VIRAMUNE can be resumed (if there is a clinical need). A decision on this should be made in each individual case, based on clinical need. Re-appointment of the drug VIRAMUNE should be carried out in conditions of increased clinical and laboratory alertness, at an initial dose of 200 mg / day (within 14 days), with its subsequent increase to 400 mg / day. If impaired liver function is resumed, VIRAMUNE should be permanently withdrawn.

In the case of hepatitis, accompanied by such clinical manifestations as anorexia, nausea, vomiting, jaundice, and a change in laboratory parameters (moderate or significant changes in liver function indicators, without taking into account the activity of gamma-glutamyl transferase), nevirapine should be completely canceled. VIRAMUNE should not be prescribed again to those patients who required its withdrawal due to the development of clinically expressed hepatitis caused by nevirapine.

Other warnings
When using nevirapine in combination with other antiretroviral drugs, the development of adverse reactions such as pancreatitis, peripheral neuropathy, and thrombocytopenia have been reported. These effects are often associated with other antiretroviral drugs. These conditions may develop with the use of nevirapine in combination with other drugs; the likelihood of a connection between these reactions with the use of VIRAMUNE is low.

Patients receiving VIRAMUNE or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection. Therefore, such patients should remain under the close supervision of a physician with experience in treating diseases associated with HIV infection. There is no evidence of the ability of nevirapine to reduce the risk of horizontal transmission of HIV 1 to each other.

Despite the fact that the ability of VIRAMUNE to prevent transmission of HIV-1 infection from a mother who has not previously received other antiretroviral drugs, the child has been established to minimize the possibility of HIV-1 transmission to the child, more intensive treatment of the mother before delivery with the use of combinations of antiretroviral drugs is recommended (when it is possible).

In women who have previously received a single dose of nevirapine in order to prevent the transmission of HIV-1 from mother to child, the effectiveness of VIRAMUNE, which is used as part of the combination therapy that these women receive for treatment, may be reduced.

In women taking nevirapine, oral contraceptives and other hormonal methods should not be used as the main method of contraception, since nevirapine can reduce their concentration. In addition, if oral contraceptives are used during nevirapine therapy for hormonal regulation, it is necessary to monitor the therapeutic effects of hormonal treatment.

Osteonecrosis: The etiology of osteonecrosis is multifactorial (the use of glucocorticosteroids, alcohol consumption, severe immunosuppression, an increase in body mass index), cases of osteonecrosis were observed in patients with advanced HIV infection and / or long-term combination antiretroviral therapy. Patients should be warned about the need to see a doctor in case of aches and pains in the joints, joint stiffness, or difficulty moving.

Immune restoration syndrome: In patients infected with HIV-1, in the presence of significant immunodeficiency during the initiation of combination antiretroviral therapy, an inflammatory reaction may occur (or intensify) in asymptomatic or residual opportunistic infectious microorganisms, which leads to serious clinical conditions. In typical cases, such reactions are observed during the first few weeks or months after the start of combination antiretroviral therapy. Typical examples are cytomegalovirus retinitis, generalized and / or local infections caused by mycobacteria, and pneumonia caused by Pneumocystic. Autoimmune diseases (e.g. Bazedova’s disease) can also occur in cases of immunity restoration syndrome. However, such diseases can occur several months after the start of treatment. Any symptoms of inflammation should be analyzed and appropriate treatment should be carried out.

The combined use of the drug VIRAMUNE with efavirenz, rifampicin, ketoconazole, delavirdine, etravirine, rilpivirin, elvitegravir (in combination with cobicystag), boceprevir is not recommended; if ritonavir is not used in a small dose at the same time: with fosamprenavir, saquinavir, atazanavir.

The drug contains methyl parahydroxybenzoate and propyl arahydroxybenzoate, these substances can cause allergic reactions (possibly delayed type).

VIRAMUNE is also available in the form of tablets (200 mg), which are convenient for use in adults, older children and adolescents whose weight is more than 50 kg or in children with a body surface area of ​​more than 1.25 square meters.

Impact on the ability to drive vehicles and mechanisms:
Special studies regarding the ability to drive vehicles and control mechanisms have not been conducted. However, patients should be advised that adverse reactions such as fatigue and headache are possible during treatment with VIRAMUNE. Therefore, caution is advised when driving or operating machinery. If the patient feels tired or complains of a headache, then potentially hazardous activities such as driving vehicles or operating machinery should be avoided.

Storage conditions:
Store at a temperature not exceeding 30 ”C.
Keep out of the reach of children.

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Active Ingredient: Capecitabine.

Xeloda (Capecitabine) is used for treating women with breast cancer that is resistant to other more commonly-used drugs.

Other names for this medication:
Capecitabin, Capecitabina, Capécitabine, Capecitabinum, Categor, Xabine.

Composition
The composition of the tablets includes the active ingredient capecitabine.

Additional ingredients: lactose, hypromellose, croscarmellose sodium, hypromellose, magnesium stearate, MCC.

The shell consists of: Opium peach Ys-1-17255-A, talc, titanium dioxide, iron oxide yellow and red.

Release form
Xeloda is produced in the form of coated tablets, packaged in blisters of 10 pieces. Tablets of 150 mg are placed in packs of 6 blisters each, the medication of 500 mg – 12 blisters each. In addition, packaging is possible in bottles of 60 and 120 tablets, respectively.

Pharmachologic effect
For Xeloda is characterized by antitumor action.

Pharmacodynamics and pharmacokinetics
The main substance of the drugcapecitabine, is a derivative of fluoropyrimidine carbamate and oral cytostatic, capable of being activated in the tumor, showing a significant selective cytotoxic effect. In this case, the cytotoxic effect is characteristic of the metabolites of this substance.

Due to the sequential enzymatic biotransformation of capecitabine in 5-FU, increased concentrations of the substance are found, which are found in the tumor, and not in the healthy tissues surrounding it. As a result of a complex mechanism of action, the drug has an effect on harmful cells, inhibiting their further development.
Inside the body, capecitabine undergoes rapid and complete absorption. It is then transformed into metabolites: 5′-deoxy-5-fluorouridine (5′-DFUR) and 5′-deoxy-5-fluorocytidine (5′-DFCT). Eating can reduce the absorption of capecitabine, but does not have a particular effect on metabolites. The maximum concentration is detected after 1.5-3.5 hours.

Metabolism of the drug occurs mainly in the liver, after which the metabolites are formed, which affect the affected areas.

Excretion from the body is carried out in the form of metabolites in the composition of urine, feces and a small part in unchanged form.

Indications for use
As a rule, Xeloda is appointed:
👉in combination therapy with docetaxel metastatic or locally advanced breast cancer, if chemotherapy is ineffective, including a drug from the anthracycline taxan, as well as contraindications to treatment with anthracyclines;
👉for adjuvant treatment of colon cancer;
👉in the treatment of first-line metastatic colorectal cancer, as well as common gastric cancer.

Contraindications
Refrain from taking this drug should:
👉hypersensitivity to capecitabine and other derivatives of fluoropyrimidine, other components of the drug;
👉established dihydropyrimidine dehydrogenase deficiency;
👉simultaneous use of sorivudin, as well as its structural analogues;
👉severe renal failure;
👉lactation, pregnancy;
👉less than 18 years old;
👉incompatibility with other components of combination therapy.

Care must be taken when:
👉CHD;
👉age of patients from 60 years;
👉simultaneous treatment with oral anticoagulants.

Side Effects of Xeloda
In the treatment of Xeloda can develop side effects, characterized by great diversity. Usually they are noted in the form of: diarrhea, stomatitis, nausea, vomiting, palm-plantar syndrome, severe fatigue, weakness, lethargy, drowsiness.

Possible development of disorders associated with the activity of the digestive system, the condition of the skin and appendages, nervous, respiratory, musculoskeletal, cardiovascular and other systems.

Deviations in the work of the sense organs, the hematopoietic system, the development of infectious complications, and changes in laboratory parameters are not excluded.

Other side effects include: fever, dehydration, weight loss, lethargy, pain in the back.

Instructions for use Xeloda (method and dosage)
Instructions for use Xeloda indicates that the drug is intended for ingestion, preferably within half an hour after eating the food, drinking water.

With monotherapy for colorectal cancer, colon and breast cancer, the standard daily dosage of the drug is 1250 mg to 2 single dose – in the morning and evening. Treatment is carried out for 3 weeks, then a break for 7 days is taken.

The purpose of the drug in combination therapy requires a special approach, strict consideration of the compatibility of drugs, features of the disease and the patient’s body.

Overdose
In case of overdose, symptoms may manifest themselves in the form of diarrhea, nausea, vomiting, inflammation of the mucous membrane, bleeding or irritation of the gastrointestinal tract, suppression of bone marrow activity.

In this case, treatment includes therapeutic and supportive procedures, which allow to eliminate clinical symptoms and prevent the development of complications.

Interaction
Appointment of Xeloda in combination with coumarin anticoagulants, for example: Warfarin and Fenprokumon, can have a negative effect on blood coagulation, causing bleeding.

It is recommended to use caution while treating cytochrome P450 substrates.

Combination with phenytoin can increase its concentration in the blood plasma. Therefore, regular monitoring of blood parameters is required.

Calcium folinate has no significant effect on the pharmacokinetics of capecitabine or metabolites, but an increased toxic effect is not excluded, since its influence on their pharmacodynamics is possible.

Combinations with Sorivudine or its analogs cause clinically significant interactions with metabolites that can cause a fatal increase in the toxicity of fluoropyrimidines. For this reason, it is necessary to take a break of at least 4 weeks between taking these medications.

Storage conditions
Storage of this drug requires a cool place out of the reach of children.

Shelf life
3 years.

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Active Ingredient: Perindopril Erbumine.

💚Aceon is used for treating high blood pressure.

Other names for this medication:
Acertil, Acerycal, Agulan, Aldoc, Apo-perindox, Armix, Asyntilsan, Bionoliprel, Biprel, Bipreterax, Cardipen, Co-prenessa, Co-prestarium, Cobathrow, Coveram, Coverene, Coverex, Coverex-as, Coversum, Covinace, Domanion, Dorover, Indapril, Inopil, Midopril, Noliprel, Pendoril, Pendrex, Percarnil, Perindal, Perindan, Perindo, Perindox, Prenessa, Prenix n, Prestance, Prestarium, Preterax, Prexanil, Prexanil a, Prexum, Prindace, Procaptan, Provinace, Reaptan, Repres plus, Spopress, Stopress, Teraxans, Tertensif kombi, Vectoryl, Vidotin.

👉Indications for use
Indications for use are narrow-profile for a therapeutic hospital due to the specificity of the therapeutic effect of the drug Perindopril:

☞arterial hypertension;
☞chronic heart failure;
☞hypertension of renovascular etiology;
☞prevention of recurrent stroke or stroke after a transient ischemic attack;
☞stable ischemic heart disease.

👉Indications for useComposition

Perindopril in the form of tablets contains:
☞perindopril erbumin (acts as the main active ingredient) – 4 mg;
☞milk sugar (lactose);
☞microcrystalline cellulose (MCC);
☞croscarmellose or primellose sodium;
☞magnesium stearate.

👉Pharmachologic effect
Perindopril is a pharmaceutical product that belongs to the group of angiotensin-converting enzyme inhibitors. Due to the chemical interaction of this catalyst with zinc ions, it is completely inactivated. As a result of such influences, the conversion of angiotensin I to angiotensin II, which has a vasoconstrictor effect, is inhibited (due to the narrowing of the vascular bed, blood pressure rises). Suppression of ACE is accompanied by effects on the kallikrein-kinin system and prostaglandins – their circulating and tissue concentrations increase.

Active metabolites of Perindopril affect the natural hormones of the human body. The production of aldosterone (the result of interaction with the renin-angiotensin-aldosterone system of the kidneys) decreases, the release of norepinephrine from sympathetic nerve endings and the formation of endothelin by the inner layer of the vascular wall are suppressed. All these changes strengthen the hypotensive effect of the pharmaceutical preparation, allowing, as they say, “to attack on all fronts”, which entails a steady decrease in blood pressure.

The drug to some extent has protective properties – Perindopril contributes to the regenerative restoration of the elasticity of large blood vessels of the arterial bed. The mechanism of this pharmaceutical effect lies in reducing the excess amount of collagen occupying the subendothelial layer of the structure. Thus, the great vessels become stronger in the physiological sense and can respond more actively to changes in blood pressure.

The cardiac effects of an ACE inhibitor consist in reducing the pre and post load on the myocardium (the total peripheral vascular resistance and the volume of blood flow decrease), thereby normalizing the work of the muscular organ, increasing its efficiency – the minute volume of blood increases without increasing the heart rate. Peripheral tissues and organs improve their trophism and regional blood flow, which is reflected in the condition of the patient’s entire body undergoing conservative therapy.

If the muscular pump is subject to such pathology as chronic heart failure, then the degree of clinical signs of this nosological unit decreases. Exercise tolerance, on the contrary, is growing rapidly. Clinical studies were conducted using a bicycle ergometric test, which confirmed the reliability of therapeutic effects in the treatment of chronic heart diseases.

👉Pharmacodynamics and pharmacokinetics
The drug is used orally, after which 25 percent of the constituent components are absorbed from the cavity of the gastrointestinal tract. Bioavailability of the drug is 65-70 percent. Interesting and even somewhat unusual is the time to reach maximum plasma concentration. The largest number of inactive substances reaches 1 hour, and the biologically active perindoprilat, the product of the active ingredient exchange in the internal environment of the body (about 20 percent of Perindopril is metabolized to this form), manifests its extreme abilities only 3-4 hours after taking the medicine.

Perindoprilat is able to bind to plasma proteins to an insignificant degree and with angiotensin-converting enzyme (slightly less than 30 percent of the active fraction). The volume of distribution of the free metabolite is 0.2 l / kg. The product exchanges mainly kidneys with a half-life of 3-5 hours. The same part, which is associated with ACE, is deploying extremely slowly, which prolongs the effective half-life to 25 hours. The cumulation of the active substance is not observed (the amount of perindoprilat and its half-life does not change in any way when the drug is taken again).

Active excretion of the active product of metabolism can be slowed down by physiological deterioration of the renal apparatus in elderly people or in chronic heart and kidney failure, therefore strict dose adjustment is required based on the creatine kinase level (constant diagnostic examinations are required during the course of treatment if the patient is in this risk group ). Dialysis clearance is 70 ml per minute.

👉Contraindications
☞increased individual sensitivity, acquired or inherited intolerance to the constituent components of a pharmaceutical preparation or the whole group of angiotensin-converting enzyme inhibitors;
☞gestation period;
☞lactation or breastfeeding;
☞angioedema of hereditary or idiopathic origin;
☞the drug is not used in pediatric practice (until the age of 18).

Separately, it is worth noting that there are a number of pathological conditions when the use of the drug Perindopril is not completely safe and requires constant diagnostic monitoring of various indicators of the body with the conditions of the hospital. The list consists of such diseases:
☞aortic or mitral stenosis;
☞constrictive pericarditis;
☞leukopenia;
☞severe autoimmune nosological units of the connective tissue (in particular, systemic lupus erythematosus or scleroderma);
☞hyponatremia;
☞the presence of a transplanted donor kidney;
☞hypertrophic cardiomyopathy;
☞thrombocytopenia;
☞cerebrovascular diseases;
☞obliterating atherosclerosis or narrowing of the lumen of vessels of other origin (especially the channel feeding the heart muscle);
☞bilateral stenosis of the renal arterioles;
☞hyperkalemia;
☞moderate or severe renal failure;
☞dehydration and exsiccosis.

👉Side effects
Perindopril is an extremely active pharmaceutical drug, which, in addition to therapeutic effects, is indicated by the frequency of adverse reactions during treatment. It makes up 1-10 percent of all cases of conservative therapy. The side effect of the constituent components can manifest itself in the form of a violation of various body systems:

Digestive tract: nausea, vomiting, indigestion, dry mouth, diarrhea, loss of appetite, cholestatic jaundice, inflammation of the pancreas, intestinal edema.
Since the cardiovascular system: excessive reduction in blood pressure with the development of orthostatic hypotension, arrhythmia, angina, stroke and myocardial infarction.
On the part of the urinary system: reduced functional ability of the kidneys, acute renal failure.
Respiratory organs: dry cough, rhinorrhea, difficulty in inhaling and exhaling, eosinophilic pneumonia, bronchospasm.
On the part of the central nervous system: headache, asthenia, dizziness, fatigue, imbalance of sleep and wakefulness, decreased mood, periodic tinnitus, disorders of the visual apparatus, muscle cramps and paresthesia.
Allergic reactions: pruritus or rash, urticaria, angioedema, erythema multiforme.
From other systems: increased sweating, impaired sexual function.
Changes in laboratory parameters – hypercreatininemia, hypohemoglobinemia, thrombocytopenia, proteinuria, hyperkalemia, hyperuricemia, neutropenia, leukopenia (agranulocytosis), pancytopenia, increased percentage and activity of liver enzymes, hemolytic anemia in the presence of glucose-6-phosphate-6-phospholiphoma-6-phosphorus, and hemolytic anemia, an increase in the percentage ratio and activity of liver enzymes.

👉Perindopril, instructions for use (method and dosage)
Pharmaceutical drug is used orally at a time (once a day). Treatment usually starts with a starting dosage of 1-2 mg per day. Further, depending on the indications for therapy, the instructions for use of Perindopril are somewhat different:

✧in case of congestive heart failure, conservative readjustment is continued with an optimal dosage of 2-4 mg per day;
✧arterial hypertension can be treated with higher amounts of the medication taken, with this pathology 4-8 mg per day is used, the dosage should be increased gradually, within 3-4 weeks;
✧renovascular hypertension is treatable at 2 mg per day;
✧prevention of stroke is carried out according to a special scheme: first, 2 mg per knock for 2 weeks, and then 4 mg per day for the same length of time;
✧therapy of stable coronary heart disease begins with a starting dose of 4 mg per day for 2 weeks, and then the amount of the drug taken increases to 8 mg per day.

👉Overdose

There are significant clinical cases of overdose with a pharmaceutical product, which, as a rule, manifests itself in the following list of symptoms:
☞excessive lowering of blood pressure;
☞shock;
☞stupor;
☞bradycardia;
☞electrolyte imbalance;
☞renal failure.

There is no specific antagonist for the drug. With this complex of adverse effects of treatment, which accompanies increased plasma concentrations of active components, symptomatic therapy is used. The following medical actions are effective:
☞gastric lavage;
☞horizontal position with a raised lower end to restore blood pressure;
☞the use of enterosorbents;
☞correction of water and electrolyte balance isotonic solution of sodium chloride;
☞atropine in the development of bradycardia;
☞effectively using hemodialysis (use of highly permeable polyacrylonitrile membranes is not recommended);
☞in a particularly severe pathological picture of overdose, implantation of an artificial pacemaker can be used.

👉Interaction

Perindopril is an extremely active pharmaceutical product (in this parameter it is even listed in the B list of the International Drug Registry), therefore, it has a long list of interactions of different nature. First of all, it should be noted products that enhance the hypotensive effect of an ACE inhibitor (excessive lowering of blood pressure can lead to orthostatic hypotension or acute cerebrovascular insufficiency):
☞agents used for anesthesia;
☞muscle relaxants;
☞anti hypertensive drugs of any mechanism of action;
☞loop and thiazide diuretics;
☞tricyclic antidepressants;
☞antipsychotic drug group;
☞organic nitrates;
☞non-selective monoamine reuptake inhibitors.
☞Indomethacin may have the opposite effect, that is, a decrease in the hypotensive effect.

Combined use of Perindopril with pharmaceuticals such as potassium-sparing diuretics, digitalis glycosides and potassium-based products (for example, active biological additives) increases the risk of hyperkalemia and all symptoms resulting from this pathological condition.

Separately, it is worth noting the interaction with Nimodipine, since a cardiac rhythm disturbance and an increase in myocardial insufficiency with the combined use of drugs in conservative therapy is clinically important.

Also, patients with diabetes should be cautious, because Perindopril increases the manifestations of the sugar-reducing effect of antidiabetic drugs. Accordingly, there is a risk of hypoglycemia and coma, as its consequences.

👉Storage conditions
Conserve Perindopril should be dry, out of the reach of children, and protected from direct sunlight. The temperature regime of optimal storage should not exceed 25 degrees Celsius.

👉Shelf life
2 years.

👉Special instructions
When using ACE inhibitors and Perindopril in particular, there is a risk of arterial hypotension, headache, dizziness and visual impairment, therefore during the period of conservative treatment it is worth refusing to independently control vehicles or other activities that require increased attention, speed and clarity of motor reactions.

The drug belongs to the pharmaceutical group of angiotensin-converting enzyme inhibitors, so technically all the drugs in this subunit of the classification of antihypertensive drugs can be used as analogues of Perindopril. Most often, with individual contraindications, the therapeutic effect is replaced by the following drugs: Hypernik, Stopress, Noliprel, Prestarium A, Perineva, Prestans.

Separately, it should be noted that Perindopril, due to its breadth of therapeutic effects and pharmacological action, is abundantly used to create combined pharmaceutical preparations. The most popular among this series are:

Perindopril PLUS Indapamide is a drug in which the therapeutic effects of Perindopril are complemented by the diuretic component. The new active component blocks the reabsorption of sodium, chlorine and water ions, selectively suppresses the activity of calcium channels and reduces the total peripheral resistance of blood vessels. A positive feature of this combination of pharmaceutical substances is a well-pronounced hypotensive effect, independent of the position of the body in space and the age of the patient. Also, the action of this drug is not accompanied by reflex tachycardia.
Perindopril Indapamide Richter is an enhanced form of the previous analog. The effect of the drug lasts for 24 hours, and persistent therapeutic effects develop in less than a month of conservative treatment. It should be emphasized that the termination of drug rehabilitation when using this form of medication is not accompanied by withdrawal syndrome, which is sometimes extremely difficult.
Perindopril Arginine is a unique medicine of its kind, because the constituent components of the antihypertensive agent are supplemented with conditionally essential amino acid, the main role of which is to be a source of NO synthase in the process of producing endogenous nitric oxide. The latter is an extremely active mediator of the organism in the pathophysiological sense. In this context, the most important are its vasodilation abilities and the regulating effects on smooth muscle tone. Thus, the hypotensive effect of the drug covers a much wider mechanism of action than Perindopril in its pure form. It should be noted that this drug combination does not prolong the list of side effects of use, since arginine is part of the natural metabolism of the human body.
Amlodipine Perindopril is a pharmaceutical product that includes another slow calcium channel blocker, a dihydropyridine derivative. In addition to the antihypertensive effect, Amlodipine also has an antianginal effect, since, by binding to the dihydropyridine receptors, it reduces the transmembrane current of calcium in smooth muscle cells of the coronary and peripheral beds. This mechanism of action and the consequences of its use put this drug in the first place among the analogues of Perindopril for indications for the treatment of coronary heart disease and angina in particular.
Perindopril-Mik is a Belarusian equivalent of a domestic pharmaceutical product. A key feature of it is the use of Perindopril t-butylamine salt (in the traditional form of the drug, a compound with erbumin is used). Due to this fact, the drug reduces pressor effects on the vascular wall (including adrenergic), which manifests itself as an angioprotective effect. It should also be noted that the therapeutic effects of this combination extend to peripheral tissues to a greater extent – they are sensitized to insulin, and therefore glucose metabolism proceeds with greater intensity.

👉For children
The drug is not used in pediatric practice until the age of 18.

👉With alcohol
While undergoing a course of conservative drug therapy, alcoholic beverages should be completely excluded, since alcohol increases the hypotensive effect of the drug, which can adversely affect the body and lead to serious consequences (sudden loss of consciousness, acute cerebral or coronary circulation insufficiency, and so on).

👉During pregnancy and lactation
Perindopril is contraindicated for use during periods of pregnancy, lactation or breastfeeding.

👉Perindopril Reviews
Messages on pharmaceutical forums unanimously reiterate the positive effect of the drug on blood pressure parameters and the work of the heart as a whole. Such an active active ingredient of Perindopril can cope with serious pathology in a relatively short course of conservative therapy. People who took a pharmaceutical drug speak very well about it, because in addition to the main therapeutic effects, it improves trophism and the delivery of beneficial nutrients to all peripheral tissues and organs, cleans the macro circulatory bed, which can not but affect the overall well-being .

Reviews of doctors about Perindopril confirm the opinion of grateful patients from a professional point of view. However, there are several points that somewhat cloud the opinion of qualified specialists. First of all, this is the frequent development of side effects during the course of Aceondrug treatment, because the incidence of adverse reactions is a catastrophic large 1-10 percent. Of course, the overwhelming majority of adverse effects is stopped quite easily, but this creates an additional burden on the patient’s body and does not always pass without a trace.

Therefore, in therapeutic hospitals, Perindopril is increasingly being replaced by combined pharmaceutical ingredients. So, for example, in combination with argininin, the number of adverse effects of conservative treatment does not increase, and the therapeutic effect, on the contrary, is growing irresistibly.

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⇝Other names for this medication:
Avidart, Duagen, Duodart, Duprost, Dutasterid, Dutasterida, Dutasteridum, Zytefor.
 

⇝Pharmacology
Drug for the treatment of benign prostatic hyperplasia. Dutasteride is a double inhibitor of 5α-reductase. Inhibits the activity of isoenzymes 5α-reductase 1 and 2 types, which are responsible for the conversion of testosterone to 5α-dihydrotestosterone (DHT). Dihydrotestosterone is the main androgen responsible for the hyperplasia of the glandular tissue of the prostate gland.

The maximum effect of dutasteride on the reduction of DHT concentrations is dose-dependent and is observed 1-2 weeks after the start of treatment. After 1 and 2 weeks of dutasterid dosing at a dose of 500 µg / day, the mean values ​​of serum dihydrotestosterone concentrations are reduced by 85% and 90%.

⇝Pharmacokinetics
Suction

After a single dose of the drug in a dose of 500 µg Cmax of dutasteride in serum is reached within 1-3 hours. Absolute bioavailability is about 60% relative to a 2-hour w / in infusion. Bioavailability of dutasteride does not depend on food intake.

⇝Distribution

Pharmacokinetic data obtained after a single and repeated intake of dutasteride, indicates a large Vd (300 to 500 liters). Dutasteride has a high degree of binding to plasma proteins (> 99.5%).

With daily intake, the concentration of dutasteride in the serum reaches 65% of the stationary level after 1 month and approximately 90% of this level after 3 months. Stationary concentrations of dutasteride in serum (Css), equal to about 40 ng / ml, are achieved after 6 months of daily intake of 500 μg of this drug. In semen, as in serum, steady-state concentrations of dutasteride are also reached after 6 months. After 52 weeks of treatment, the concentration of dutasteride in semen averaged 3.4 ng / ml (from 0.4 to 14 ng / ml). Approximately 11.5% of dutasteride gets into the semen from blood serum.

⇝Metabolism

In vitro, dutasteride is metabolized by a CYP3A2 isoenzyme to form two small monohydroxylated metabolites; however, it is not affected by the isoenzymes CYP2C9, CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2B6, CYP2C19 and CYP2D6. After reaching Css dutasteride, unchanged dutasteride, 3 large metabolites (4′-hydroxydutasteride, 1,2-dihydrodutasteride and 6-hydroxydeasteride) and 2 small metabolites are detected in the serum using the mass spectrometric method.

⇝Removal

In humans, dutasteride is extensively metabolized. After ingestion of dutasteride at a daily dose of 500 µg to achieve Css from 1% to 15.4% (on average 5.4%) of the dose taken is excreted through the intestine unchanged. The rest is excreted in the form of 4 large metabolites, constituting 39%, 21%, 7% and 7%, respectively, and 6 small metabolites (each of which accounts for less than 5%).

Traces of unchanged dutasteride (less than 0.1% of the dose) are excreted through the kidneys in humans.

When receiving therapeutic doses of dutasteride, its final T1 / 2 is 3-5 weeks.

Dutasteride is detected in the serum (at concentrations above 0.1 ng / ml) up to 4-6 months after discontinuation.

⇝Linearity / nonlinearity

The pharmacokinetics of dutasteride can be described as a first-order absorption process and two parallel elimination processes, one saturated (that is, dependent on concentration) and one unsaturated (that is, not dependent on concentration). At low serum concentrations (less than 3 ng / ml), dutasteride is rapidly excreted through both elimination processes. After a single dose in doses of 5 mg or less, dutasteride is quickly eliminated from the body and has a short half-life of 3-9 days.

At serum concentrations above 3 ng / ml, the clearance of dutasteride occurs more slowly (0.35–0.58 l / h), mainly by means of a linear, unsaturated elimination process with a final T1 / 2 of 3-5 weeks. At therapeutic concentrations, with a daily intake of 500 µg, slower clearance of dutasteride prevails; total clearance is linear and not dependent on concentration.

⇝Older men

The pharmacokinetics and pharmacodynamics of dutasteride were studied in 36 healthy men aged from 24 to 87 years after taking one dose (5 mg) of this drug. There were no statistically significant differences between different age groups in pharmacokinetic parameters such as AUC and Cmax. There were also no statistically significant differences in the dutasterid T1 / 2 values ​​between the age groups of men 50-69 years and over 70 years, which include most men with benign prostatic hyperplasia.

Between different age groups there were no significant differences in the degree of reduction of DHT levels. These results demonstrate that there is no need to reduce the dose of dutasteride in elderly patients.

⇝Dosage
The drug can be taken regardless of the meal.

Capsules should be swallowed whole, not chewed and not opened, because the contents of the capsule can cause irritation of the mucous membrane of the oropharynx.

Benign prostatic hyperplasia (BPH)

Adult men (including the elderly) The recommended dose of Avodart is 1 capsule (500 µg) 1 time / day. Capsules should be taken whole.

Although improvement with the use of the drug comes fairly quickly, treatment should be continued for at least 6 months in order to objectively evaluate the therapeutic effect.

For the treatment of BPH, Avodart may be prescribed as monotherapy or in combination with alpha1-blockers.

⇝Special patient groups

When receiving 500 mg / day, the kidneys excrete less than 0.1% of the dose, so there is no need to reduce the dose in patients with impaired renal function.

Currently there are no data on the use of Avodart in patients with impaired liver function. Since dutasteride undergoes intensive metabolism, and its half-life is 3-5 weeks, care must be taken when treating Avodart with patients with impaired liver function.

⇝Overdose
When prescribing dutasteride up to 40 mg / day once (80 times higher than the therapeutic dose) for 7 days, no significant side effects were noted. When conducting clinical trials, patients received dutasteride at a dose of 5 mg daily for 6 months, while no additional side effects were found to those that were observed while receiving 500 μg of dutasteride.

There is no specific antidote for dutasteride; therefore, if an overdose is suspected, it is sufficient to conduct symptomatic and supportive treatment.

⇝Side effects
The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥ 1/10 000 and < 1/1000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration observation.

The frequency of occurrence of adverse events, formed on the basis of post-registration observation

⇝The immune system
– Allergic reactions (including rash, itching, urticaria, localized edema) and angioedema

⇝ From the skin and subcutaneous fat
– alopecia (mainly loss of body hair) or hypertrichosis

⇝Mental disorder
– depressed state

⇝From the reproductive system
– testicular pain, testicular edema

The frequency of occurrence of adverse events, formed on the basis of data from clinical studies (adverse events associated with the use of dutasteride as monotherapy)

⇝Indications
– as monotherapy for the treatment and prevention of progression of benign prostatic hyperplasia by reducing its size, relieving symptoms, improving urination, reducing the risk of acute urinary retention and the need for surgery;
– as a combination therapy with alpha1-blockers for the treatment and prevention of progression of benign prostatic hyperplasia by reducing its size, relieving symptoms, improving urination, reducing the risk of acute urinary retention and the need for surgery. The combination of dutasteride and tamsulosin alpha1-blocker was mainly studied.

⇝Contraindications

– hypersensitivity to dutasteride and other components of the drug;
– hypersensitivity to other 5α-reductase inhibitors;
– caution should be prescribed the drug for liver failure;
Avodart is contraindicated for women and children. Precautions should be prescribed the drug for liver failure.

⇝Special instructions
Dutasteride is absorbed through the skin, so women and children should avoid contact with damaged capsules. In case of contact with damaged capsules, it is necessary to immediately wash the corresponding skin area with soap and water.

⇝Liver dysfunction

Currently there are no data on the use of Avodart in patients with impaired liver function. Since dutasteride undergoes intensive metabolism, and its half-life is 3-5 weeks, care must be taken when treating Avodart with patients with impaired liver function.

⇝Heart failure with combined use of dutasteride and tamsulosin

In two 4-year clinical studies, the incidence of heart failure was higher in patients who received the combination of dutasteride and alpha1-blocker, mainly tamsulosin, than in patients who did not receive the combined treatment. In these two studies, the incidence of heart failure remained low (≤ 1%), with some variability between them. But in general, there was no discrepancy in the incidence of side effects from the cardiovascular system. The causal connection between treatment with dutasteride (as monotherapy or in combination with an alpha1-blocker) and the development of heart failure has not been established.

Effect on the detection of prostate-specific antigen (PSA) and prostate cancer (PCa)

Patients need to conduct a digital rectal examination, as well as use other methods of research of the prostate gland, before starting treatment with dutasteride, and periodically repeat them during treatment to rule out the development of prostate cancer.

The information can not be used to replace direct consultation with a doctor or make a decision on the use of medicines.

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Active Ingredient: Sulfamethoxazole Trimethoprim.

♻Composition
Oral suspension: 200 mg sulfamethoxazole + 40 mg trimethoprim – active substances.

Additional ingredients: dispersible cellulose, propyl parahydroxybenzoate, methyl parahydroxybenzoate, polysorbate 80, sorbitol, banana and vanilla flavors, purified water.

Tablets: 800 mg sulfamethoxazole + 160 mg trimethoprim – active substances.

Additional ingredients: sodium glycolate starch, povidone, sodium dokuzat, magnesium stearate.

♻Release form
Suspension for oral administration – Bactrim 50 ml or 100 ml per pack, complete with a measuring spoon.

The tablets in the shell – Bactrim Forte 10, 20 or 50 pieces per pack.

♻Pharmachologic effec
Antibacterial.

Pharmacodynamics and pharmacokinetics
Bactrim and Bactrim Forte are bactericidal combination chemotherapeutic drugs that include the active components sulfamethoxazole and trimethoprim (co-trimoxazole), exhibiting a synergistic effect. The mechanism of action of co-trimoxazole is the blocking of two enzymes, which in microorganisms boost the stages of sequential replication of folinic acid. Due to this, bactericidal effects (in vitro) are observed in concentrations at which the active ingredients separately, exhibit only a bacteriostatic effect.

In addition, the effectiveness of co-trimoxazole is much greater than the effect of a single component in relation to pathogens resistant to it. The antibacterial effect of co-trimoxazole (in vitro) covers many pathogenic gram-positive and gram-negative microorganisms.

After oral administration (inside), co-trimoxazole is rapidly and mostly absorbed in the upper part of the gastrointestinal tract.

In the blood reaches Cmax in a period of time from one hour to four. Keeps antibacterial concentration for 7 hours. One day after taking one dose, a small amount of co-trimoxazole is observed in the plasma. Equilibrium concentration is observed after 2–3 days.

Trimethoprim binds to plasma proteins by 44%, and sulfamethoxazole by 70%.

Biotransformation to inactive metabolites occurs in the liver, through acetylation. Distribution in the body runs evenly, with penetration through histohematogenous barriers. In urine and lungs, the concentration of co-trimoxazole exceeds plasma. In the secrets of the prostate and bronchial; saliva; vaginal discharge; in the interstitial, spinal and middle ear fluids; bile; bones; breast milk; eye mucosa accumulates to a lesser extent.

Both active ingredients have the same elimination rate. T1 / 2 increases depending on age: up to 12 months – 7-8 hours, from year to ten – 5-6 hours, in adults – 10-11 hours. With impaired renal function and in the elderly T1 / 2 increases.

They are mainly excreted by the kidneys in a ratio of 10–30% sulfamethoxazole and 50–70% trimethoprim.

♻Indications for use
Respiratory tract: bronchiectasis, croupous pneumonia, pneumocystic pneumonia, bronchitis (chronic and acute), bronchopneumonia.

Urogenital system: urethritis, pyelitis, cystitis, pyelonephritis, lymphogranuloma venereal, epididymitis, prostatitis, gonorrhea (of both sexes), chancroid, inguinal granuloma.

ENT organs: sinusitis, tonsillitis, otitis media, scarlet fever, laryngitis.

Gastrointestinal tract organs: paratyphoid fever, typhoid fever, cholangitis, salmonello carrier, dysentery, cholera, cholecystitis, gastroenteritis, provoked by the enterotoxic strains of Escherichia coli;

Skin: furunculosis, pyoderma, acne, wound infections;

Others: osteomyelitis (chronic and acute) and other osteoarticular infectious diseases, acute brucellosis, malaria (Plasmodium falciparum), South American blastomycosis, toxoplasmosis (in complex treatment).

♻Contraindications
▶hypersensitivity to co-trimoxazole, other components, including sulfonamides;
▶liver failure;
▶aplastic anemia;
▶kidney function failure, with CC less than 15 ml / min;
▶B12-deficiency anemia;
▶glucose-6-phosphate dehydrogenase deficiency;
▶leukopenia;
▶agranulocytosis;
▶lactation and pregnancy;
▶age up to 3 months;
▶pediatric hyperbilirubinemia.

Carefully:
▶thyroid pathology;
▶porphyria;
▶bronchial asthma;
▶folic acid deficiency.

♻Side effects

Blood formation organs:
➲neutropenia;
➲leukopenia;
➲megaloblastic anemia;
➲thrombocytopenia;
➲agranulocytosis.

Nervous system:
➲tremor;
➲headaches;
➲dizziness;
➲apathy;
➲depression;
➲peripheral neuritis;
➲aseptic meningitis.

Gastrointestinal tract:
➲decreased appetite;
➲nausea, passing into vomiting;
➲gastritis;
➲diarrhea;
➲stomach ache;
➲stomatitis;
➲glossitis;
➲cholestasis;
➲hepatitis;
➲hepatonecrosis;
➲pseudomembranous enterocolitis;
➲increased transaminase activity of the liver.

Respiratory system:
➲bronchospasm;
➲infiltrates of the lungs.

Urinary system:
➲interstitial nephritis;
➲polyuria;
➲kidney impairment;
➲hematuria;
➲crystalluria;
➲hypercreatininemia;
➲urea increase;
➲toxic nephropathy with anuria and oliguria.

Musculoskeletal system:
➲myalgia;
➲arthralgia.

Allergic reactions:
➲photosensitization;
➲rash;
➲itching;
➲exudative erythema multiforme (in particular, Stevens-Johnson syndrome);
➲exfoliative dermatitis;
➲epidermal toxic necrolysis;
➲fever;
➲allergic myocarditis;
➲hyperemia of sclera;
➲angioedema.

Others:
➲hypoglycemia.

♻ Bactrim, instructions for use (method and dosage)
Suspension Bactrim and Bactrim Forte tablets are taken orally after a meal, the tablets are washed down with water.

Instructions for use Bactrim suspension
Acceptance of Bactrim involves the dosage of the drug by means of a measuring spoon containing 5 ml. Since the age of 12 years, the usual dose of Bactrim is 20 ml in the morning and evening. During long-term therapy, a dose of 10 ml in the morning and 10 ml in the evening is indicated. In severe cases of the disease, it is allowed to take matins and evening doses of 30 ml each.

In the case of acute infections, Bactrim is taken for at least 5 days, or until the time of complete disappearance of symptoms within 2 days. Conducting weekly therapy without signs of improvement in the patient’s condition is a reason for dose adjustment or treatment changes.

In the treatment of soft chancre, Bactrim is prescribed 20 ml twice a day. If there is no healing after 7 days, it is possible to prolong the therapy for the next week. It should be borne in mind that the ineffectiveness of treatment may be associated with resistance of the pathogen.

In the treatment of uncomplicated acute urinary tract infections prescribed to women one-time in the amount of 40-60 ml. Take the suspension is recommended in the evening (at bedtime).

When treating patients undergoing hemodialysis, they take the first normal loading dose of Bactrim, and then proceed to receive half or one third of the usual dose, with a break in a day or two.

In the treatment of pneumonia provoked by Pneumocystis carinii, up to 20 mg of trimethoprim and up to 100 mg of sulfamethoxazole per day per kilogram of body weight are prescribed. Bactrim take two weeks every 6 hours, in equal parts. The maximum dose, with a body weight of 8 kg, is 5 ml and increases by 5 ml for each subsequent 8 kg of weight, respectively. For example, a body weight of 32 kg will require a dose of 20 ml.

In order to prevent pneumonia, provoked by Pneumocystis carinii, patients over the age of 12 years are recommended to take 20 ml of suspension (4 spoons) per day. The children’s daily dose is 150 mg / m2 of trimethoprim and 750 mg / m2 of sulfamethoxazole in two equivalent doses, every week for 3 days in a row. The total dose in 24 hours should not exceed 320 mg of trimethoprim and 1600 mg of sulfamethoxazole.

A newborn from 3 to 5 months is shown morning and evening intake of 2.5 ml of suspension. Children from 6 months to 5 years old morning and evening intake of 5 ml, from 6 to 12 years old morning and evening intake of 10 ml.

In the case of severe infections, the dose can be increased by one and a half times.

With Nocardiosis, it is prescribed in adults 60–80 ml, for 3 months and longer (sometimes up to 1.5 years). The dosage depends on the weight, kidney function, age and severity of the infectious disease.

In case of kidney pathologies of CC 15–30 ml / min, the dose is halved and is not recommended for administration with CC less than 15 ml / min.

♻Instructions for use Bactrim Forte
The usual morning and evening dose for patients after 12 years is 960 mg. When conducting long-term treatment, you can get half of this dose, and in particularly difficult situations, increase the usual dose by one and a half times.

Reception of Bactrim Forte continues for at least 5 days, or until the absence of symptoms within 48 hours. Conducting weekly therapy without signs of improvement in the patient’s condition is a reason for dose adjustment or treatment changes.

In the treatment of soft chancre, 960 mg is prescribed twice a day. If there is no healing after 7 days, it is possible to prolong the therapy for the next week. It should be borne in mind that the ineffectiveness of treatment may be associated with resistance of the pathogen.

In the treatment of uncomplicated acute urinary tract infections, women are prescribed one-time 1920-280 mg. It is recommended to take pills before meals in the evening (at bedtime).

When treating patients undergoing hemodialysis, they take the first normal loading dose of Bactrim Forte, and then proceed to receive half or one third of the usual dose, with a break in a day or two.

In the treatment of pneumonia provoked by Pneumocystis carinii, up to 20 mg of trimethoprim and up to 100 mg of sulfamethoxazole per day in four divided doses are taken, for 2 weeks. The maximum dose, with a body weight of 32 kg, is 960 mg (1 tablet) and increases by 480 mg for every subsequent 16 kg of weight, respectively. For example, a body weight of 48 kg will require a dose of 1440 mg.

In order to prevent pneumonia, provoked by Pneumocystis carinii, patients after the age of 12 years are recommended to take 1 tablet daily (960 mg). Patients under 12 years of age are recommended to take Bactrim suspension.

In Nocardiosis, 3-4 tablets (2880-3840 mg) are prescribed in adulthood for 3 months or longer (sometimes up to 1.5 years). The dosage depends on the weight, kidney function, age and severity of the infectious disease.

In case of kidney pathologies of QA more than 30 ml / min, they take the usual dose of Bactrim Forte, with QC less than 15 ml / min, I do not recommend taking this drug.

♻Is baktrim an antibiotic or not?
Medicines Bactrim and Bactrim Forte are sulfonamides in combination, which, like antibiotics, exhibit an antibacterial effect, but unlike them have a chemical, rather than a natural or semi-synthetic structure. It is due to the combination of sulfamethoxazole and trimethoprim, in relation to susceptible microorganisms, it shows not only a bacteriostatic, but also a bactericidal action, which is not as effective as some antibiotics.

♻Overdose
Overdose symptoms manifest as nausea, vomiting, dizziness, intestinal colic, headache, depression, drowsiness, fainting, visual disturbances, confusion, fever, crystalluria and hematuria. Overdose for a long time can lead to leukopenia, thrombocytopenia, jaundice and megaloblastic anemia.

Conduct gastric lavage, internal fluid intake, acidification of urine, in order to enhance the excretion of trimethoprim. Recommended in / m the introduction of 5-15 mg per day of calcium folinata, to eliminate the effects of trimethoprim on the bone marrow. If necessary, conduct hemodialysis.

♻Interaction
Bactrim and Bactrim forte, when administered together with indirect anticoagulants, increase their activity and also enhance the effects of Methotrexate and hypoglycemic drugs.

Co-trimoxazole increases the effects of warfarin and phenytoin, as well as reduces the effectiveness of oral contraceptives and tricyclic antidepressants.

Taking Rifampicin affects T1 / 2 trimethoprim in the direction of its reduction.

Diuretics increase the likelihood of thrombocytopenia, and Pyrimethamine, when taken more than 25 mg in 7 days, increases the possibility of megaloblastic anemia.

Combined co-trimoxazole with diuretics and oral hypoglycemic drugs can cause a cross-allergic reaction.

PAS, barbiturates and phenytoin increase the symptoms of folic acid deficiency.

Parallel administration of indomethacin can lead to an increase in the blood concentration of sulfamethoxazole.

Bactrim and Amantadine, when used together, can cause toxic delirium.

When co-trimoxazole is taken, digoxin serum concentration may increase (especially in the elderly).

With co-trimoxazole therapy, dofetilide is contraindicated.

♻Storage conditions
Bactrim – up to 25 ° C.

Bactrim Forte – up to 35 ° C.

♻Shelf life
Bactrim and Bactrim forte, in unopened packaging, can be stored for 5 years.

♻Special instructions
In the event of a skin rash or other side effects of a severe nature, treatment with Bactrim must be canceled.

Patients suffering from asthma and prone to allergic reactions, co-trimoxazole is prescribed with extreme caution.

The duration of therapy with co-trimoxazole should be minimal, especially for patients in old age.

Kidney pathologies require a dose adjustment of Bactrim.

During long-term treatment with Bactrim, there is a need to regularly determine the number of formed elements in the blood. With a significant decrease in the number of any of the elements, therapy should be canceled. Patients with severe hematological pathologies can be prescribed co-trimoxazole only in the most extreme cases.

With kidney failure, folic acid deficiency, hematological changes characteristic of folic acid deficiency can be observed in old age. These changes are compensated by the appointment of folic acid.

In the case of long-term use of co-trimoxazole, especially when kidney failure, regular monitoring of urine composition and kidney function is necessary.

In order to prevent crystalluria, it is necessary to provide the body with a sufficient volume of fluid and to follow an adequate diuresis.

Patients with glucose-6-phosphate dehydrogenase deficiency can be prescribed co-trimoxazole only in minimal doses and for absolute reasons.

With proper diet, trimethoprim, disrupting the exchange of phenylalanine, does not affect patients suffering from phenylketonuria.

The appointment of co-trimoxazole requires extreme caution in diseases of the thyroid gland and porphyria.

Patients whose metabolism is “slow acetylation” are more susceptible to idiosyncrasy to sulfonyl amides.

♻For children
Bactrim and Bactrim Forte are contraindicated for children up to 3 months, at a different age are prescribed according to the recommendations for use.

♻During pregnancy (and lactation)
Co-trimoxazole preparations are contraindicated during lactation and pregnancy.

♻ Reviews Bactrim
Different people who took these drugs, put aside the opposite reviews about Bactrim and Bactrim forte. For some, these drugs have become a great helper; for others, their intake turned out to be only side effects. It is worth noting that co-trimoxazole preparations indeed have many contraindications and a rather significant list of side effects, in connection with which, their purpose is advisable only in the case of reliable indications taking into account the history and reactions of the individual patient.

For children, reviews of Bactrim suspension are also varied and do not provide an opportunity to form an unequivocal opinion about its effectiveness and safety. The only conclusion that can be made by examining parents reviews is that only an experienced doctor should prescribe this drug, after conducting various tests and studies, and only in this case therapy will be effective and relatively safe.

♻ Other names for this medication:
Actrim, Adrenol, Alfatrim, Altavit, Anitrim, Apo-bactotrim, Apo-sulfatrim,  Assepium, Astrim, Avlotrin, Bacin, Bacsul, Bacta, Bactekod, Bactelan, Bacterol, Bacticel, Bactipront, Bactiver, Bactoprim, Bactramin, Bactricid, Bactricida, Bactrimel, Bactrizol, Bactron, Bactropin, Baktar, Baktimol, Bakton, Balkatrin, Balsoprim, Bascul, Berlocid, Betam, Bioprim, Biotrim, Biseptol, Biseptrin, Bismoral, Bitrim, Broncoflam, Bucktrygama, Cadaprim-r,  Cadiprim,  Canibioprim, Casicot, Chemitrim, Chevi-trim, Ciplin, Clotrimazol al, Co-sultrin, Co-trim, Co-trimoxazol, Co-try, Colizole, Comox, Cosat, Cotreich,  Cotribene, Cotrim, Cotrimol, Cotrimox, Cotrimoxazol, Cotrimstada, Cotripharm, Cotrix, Cotrizol-g, Cots, Cozole, Daiphen, Danferane, Deprim,  Dhatrin, Diatrim 24, Dientrin, Diseptyl, Ditrim, Doctrim, Dosulfin,  Dotrim, Droxol, Drylin, Ectaprim, Editrim, Eliprim, Epitrim, Erphatrim, Esbesul, Escoprim, Eusaprim, Exazol, Feedmix ts, Fisat, Forcrim, Gantrisin,  Gentrim, Globaxol, Groprim, Groseptol, Ifitrim, Ikaprim, Infatrim, Infectrim, Infectrin, Irgagen, Jasotrim, Kaftrim, Kanprim, Kemoprim, Kepinol, Kombitrim, Lagatrim, Lapikot, Letus, Licoprima, Linaris, Lupectrin, Medibiot, Megaset, Megatrim, Meprim, Methotrin, Methoxasol, Metoprim, Metoxiprim, Metrim, Momentol, Navatrim, Neoset, Neotrim, Netocur, Nopil, Novidrine, Novo-trimel, Novotrim, Noxaprim, Nu-cotrimox, Nufaprim,  Octrim,  Omsat, Onetrim, Organosol, Oribact, Oriprim, Ottoprim, Pehatrim, Pharex co-trimoxazole, Plocanmad, Politrim, Primadex, Primazol,  Primazole,  Primotren, Primsulfon, Purbac, Qiftrim, Regtin, Resprim, Ribatrim, Roxtrim, Sanprima, Sepmax, Septra, Septran, Septrin, Servitrim, Shatrim, Sigaprim, Sinatrim, Sinersul, Sitrim, Soltrim, Spectrem, Suftrex, Sulbron, Sulfa, Sulfagrand, Sulfamethoxazol, Sulfaméthoxazole, Sulfamethoxazolum, Sulfametoxazol, Sulfatalpin, Sulfatrim, Sulfoid, Sulfoprima, Sulmetrim, Sulotrim, Sulphatrim, Sulphax, Sulphytrim, Sulprim, Sultri-c, Sultrian, Sultrim,  Sultrima, Sumetoprin, Sumetrolim, Sunatrim, Suprasulf, Supreme, Suprim, Suprimass, Sutrim, Tabrol, Tagremin, Terasul-f, Terbosulfa,  Theraprim,  Tmps, Trelibec, Trifen, Triforam, Trim sulfa, Trima-kel, Trimaxazole,  Trimecor, Trimesulf, Trimesulfin, Trimethazol, Trimethox, Trimetoger, Trimetoprim sulfa, Trimexazol, Trimexole-f, Trimezol, Trimidar-m, Trimoks, Trimol, Trimosazol, Trimosul, Trimoxsul, Trimsulint, Tripur, Trisolvat, Trisul, Trisulf, Trisulfose, Trisulin, Tritenk, Trizole, Two-septol, Urisept, Urobactrim, Vanadyl, Vanasulf, Wiatrim, Xepaprim, Yen kuang, Zaxol, Zoltrim.
 

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Other names for this medication :
Aczone, Dapoxetin, Dapoxetina, Dapoxetine hydrochloride,  Dapoxetinum, Dapsone, Everlast, Priligy .
 

DAPOXETIN: COMPOSITION, THERAPEUTIC EFFECTIVENESS AND OTHER PHARMACOLOGICAL PARAMETERS.

To date, pharmacies pharmacists offer a huge range of drugs to increase potency. However, how to be in a situation when the erection is ok, but its duration is not enough for a full sexual intercourse and the satisfaction of the partner?

According to doctors, such problems are usually associated with increased sensitivity of nerve endings located in the area of ​​erogenous zones of the genitals and a malfunctioning of the smooth muscles of the penis.

Dapoxetine is a drug intended for the relief of disorders associated with premature ejaculation.

In this article, you can read the instructions for use of the drug Priligy. Presented are reviews of visitors to the site – consumers of this medication, as well as opinions of doctors specialists on the use of Dapoxetine in their practice.

A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation.

Analogues or generics of Dapoxetine in the presence of existing structural analogues.

Use to treat premature ejaculation in men and enhance potency. Composition and interaction of the drug with alcohol.

Method of application (dosage)
A day drink on the pill, drinking plenty. The best effect is achieved when taking a couple of hours before sexual intercourse. The maximum daily dose is 60 mg.
During therapy, refusal of alcohol is required. The pressure on the vessels and heart is increased, special vigilance should be shown. In addition, Dapoxetine does not relieve the risk of contracting sexually transmitted diseases.
You can not use it simultaneously with thioridazine, tramadol, antidepressants, as well as with lithium, monoamine oxidase inhibitors, sedatives. Plus with nelfinavir, tryptophan, many medicinal doses, ketoconazole, telithromycin, as well as ritonavir, itraconazole.

The effect of Dapoxetine

The main active component of the drug is Dapoxetine hydrochloride. In addition, Priligy contains auxiliary substances that enhance the medicinal properties of the drug and minimize the likelihood of side effects.

Under the influence of the drug there is a blockage of serotonin, which allows:
➢ delay the process of ejaculation;
➢ prolong the sexual intercourse several times.

Dapoxetine with alcohol

Dapoksetin is not recommended for taking in combination with alcoholic beverages. Ethanol, which is part of any alcohol, disrupts the effectiveness of the drug Dapoxetine and significantly slows the appearance of the result.
Moreover, in some cases, this combination can cause serious and dangerous poisoning. Experts insist on complete refusal of alcohol during the period of taking the drug.

Description
It is unlikely that in our time you can meet a man who would be pleased with the size of his penis. Low sensitivity of the penis head, insufficient level of erection, problems with potency, development of erectile dysfunction – such factors can not positively affect the sexual life of a married couple.

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Dapoxetine is the best modern drug used in the fight against early ejaculation, impotence and erectile dysfunction. The advantages of using the product are undeniable: the quality of tablets is confirmed by numerous certificates in the field of medicine and pharmacology.
In the process of treatment, you do not need to adhere to a special rhythm of life and monitor the condition of your body. The product does not cause habituation, severe allergic reaction and side effects.
You can not worry about hygiene: unlike various gels and creams, Dapoxetine tablets leave no traces on the skin and underwear. The formula of Dapoxetine is designed in such a way that it is immediately absorbed by the walls of the stomach and begins its action.

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Provigil
Active Ingredient:
Modafinil

Other names for this medication :
Modalert, Modvigil

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Modafinil is a prescription drug for patients with narcolepsy, increases concentration of attention and relieves drowsiness, also enhances the perception and memory capacity. Modafinil as a biologically active additive takes an honorable place among nootropic drugs. Modafinil is a drug that relieves sleepiness in the daytime and for the treatment of narcolepsy. It is possible to improve perception by stimulating neurotransmitters in the brain, used to improve mental abilities.

Description
Provigil or benzhydryl sulfinylacetamide is a central stimulant (psychostimulant). The substance has been approved by the FDA for the treatment of narcolepsy (a disease characterized by sudden and uncontrolled bouts of deep sleep, fatigue or excessive drowsiness), sleep apnea, and sleep disorders caused by changes in the mode of operation.
The quality of the drug was tested, including, as a remedy for the treatment of Alzheimer’s disease, depression and attention deficit disorder. Modafinil belongs to a group of drugs known as eugeroics (stimulants) that promote mental alertness and attention.
One of the known mechanisms of action of these drugs is the agonism of alpha-1-adrenergic receptors, as a result of which drugs affect the mood, increasing energy by increasing the release of dopamine in the central nervous system. This also leads to changes in the levels of GABA and glutamate. In studies of modafinil as a stimulant, the advantages of the drug were shown in comparison with amphetamines.
To begin with, the substance is supposed to have a much lower potential for abuse due to the fact that its effect does not cause the same euphoria. In addition, the drug has a lesser effect on peripheral CNS stimulation (that is, it shows fewer side effects), has minimal effect on blood pressure, does not cause sleep interruptions (no hangover or need to catch up on sleep), and, according to clinical trials, has a more reliable security profile.
The drug is used even by the US military as an energy stimulant for pilots and soldiers needed to work for long periods of time without sleep. This is not so strange as it may seem at first glance, since in the past military pilots and soldiers widely used dexedrine (amphetamine) during long periods of lack of sleep.
Provigil has been tested in recent combat situations, such as Afghanistan and Iraq, and may in the future be officially recognized as a special preparation for the military.

Recently, modafinil has gained popularity among competitive athletes. They use it not just as a medicine for “vivacity”, but as a stimulant, increasing productivity and endurance. This use is likely to be a surprise to the developers of this drug, as previously it was reported that this “gently” vigilant drug does not have strong stimulatory effects, and can not improve athletic performance.
Recent research contradicts these statements. A study in Canada showed that taking Provigil can provide significant sports benefits. In a double-blind study, 15 male volunteers took the drug at a dose of 4 mg per kg of body weight (equivalent to 200 mg for a person weighing 220 pounds), or a placebo.
Three hours after the meal, aerobic exercises were performed on the veloergometer at 85% of the maximum aerobic capacity, until exhaustion. Taking Provigil, men could exercise for significantly longer periods of time (up to 30% longer), and used more inhaled oxygen for exercise. Also reported was a decrease in subjectively perceived tension, resulting in increased productivity during training.

History
Provigil was developed by Lafon Laboratories in France. In 1998, the drug was approved by the FDA for sale in the United States, where it was sold under the brand name Provigil.
Provigil also occurs in the international market under this and several other trade names, including Modiodal, Vigil, Alertec and Modasomil. Although the drug has favorable safety indicators, in the United States for some time it was considered a drug capable of provoking possible abuses.
Currently, Provigil is on the list of IV controlled substances, along with Valium and Xanax. Thus, its use for non-medical purposes is limited by significant legal sanctions for possession and import of the drug. The drug has a fairly wide medical use, including sleep disorders associated with changes in the mode of operation.
The drug is often prescribed by prescription. In 2000-2004, Modafinil became popular among competitive athletes, before sports authorities did not begin to worry about the use of the drug. In 2004, a doping scandal erupted in connection with the company Valco, when it became known that many of the athletes who gave a positive result for the use of tetrahydrogestrenone, also used Provigil.
After this, the IOC prohibits the use of Modafinil, and a number of studies have developed a methodology for detecting this chemical in the urine. Now this testing is part of the standard survey of athletes before the Olympic Games. Most other international sports bodies have followed the example of the IOC to ban and test Modafinil.
Since then, the drug has lost its appeal as “invisible” in checks, although it is still used by many athletes who do not undergo random urine testing.

How Supplied
Provigil is most often supplied in the form of tablets of 100 mg and 200 mg each.

How to use?
The drug “Modafinil“, the instruction to which must necessarily be attached, should be prescribed only by a doctor. The doctor also prescribes the necessary dose for a particular patient. Usually the specialist prescribes 2-4 tablets per day. The drug should be taken in the morning and at lunch.
If a patient has arterial hypertension, then during treatment with Medafinil medication, the price of which will be indicated below, he needs to control blood pressure. If the patient has liver function, then the dose is reduced to 0.1-0.2 g per day.

Pharmacology
Blood serum
The half-life of modafinil is 13-15 hours, and the concentration in the serum in the equilibrium state reaches 2 days after the onset of admission. The half-life of the S-isomer of modafinil is 4-5 hours, whereas in the R-isomer of modafinil, the period is longer (15 hours) and thus the intake of armodafinil is almost equivalent to taking Provigil.
The results of the experiments showed that the concentration of ardomafinil in the blood is 18% higher than in the case of modafinil (5.44 +/- 1.64 mg / ml versus 4.61 +/- 0.73 mg / ml) and accumulates in a shorter time interval (1.8 hours against 2.5 hours), and the total concentration of ardomafinil in the urine is higher by 32-40%.
Although both variants of modafinil (modafinil and armomafinil) have the same half-life, the effect of armomofinil on the body is more pronounced (according to the content in the urine and blood).

Localization
According to the immunocytochemistry data of the c-Fos gene (the gene responsible for the stimulation response and detected by neural stimulation or sleep deprivation), the introduction of modafinil to cats caused a sharp activation of the c-Fos gene in the anterior hypothalamic nucleus and adjacent areas and was weak in the suprachiasmatic nucleus and minimal activation of the gene in other areas, for example, in the cerebral cortex or striatum.
Such a pinpoint activation of the hypothalamus was noticeable everywhere, and amygdala was involved in the process. Studies in humans showed clear differences between the effects on humans of modafinil and amphetamine.

In contrast to the effects of amphetamine or methylphenidate – excessive vivacity (which indicates a widespread neuronal activation), modafinil also acts selectively: the hypothalamus and amygdala.

Neurology
Dopaminergic effect
Provigil is able to increase extracellular levels of dopamine in the prefrontal cortex in rats and in the caudate nucleus in dogs.
Modafinil acted on dopamine and noradrenaline receptors (in the striatum), and the absence of such an effect in mice was associated with the disappearance of the effects associated with sleep, which was confirmed by the fact that the Provigil exposure mechanism does affect sleep.
Recent studies have shown an insufficient effect of modafinil on dopaminergic systems, which may be due to a lower dosage used previously.

Andrenergic effect
The invigorating effect of modafinil is significantly weakened by antagonists of adrenergic receptors (alpha and beta subunit), however, inhibition of catecholamine synthesis by α-methylparathyrosine does not reduce the effect.

Orexinergic effects
In people with deficiency of orexin (nalotics) modafinil shows good results, directly affecting orexin neurons. This effect has had the greatest effect on mice with deficiency, the effect of modafinil on the orexin system of healthy individuals and humans is unknown. 3.5.
Sedative and stimulatory effects The results of some studies are negative for the effects of modafinil during intentional sleep deprivation, since the effect of 300 mg of Provigil during sleep deprivation is equivalent to taking 20 mg of D-amphetamine.
However, it was noted that the deterioration of self-control (the ability to accurately assess yourself and your environment) changes toward excessive self-confidence (an incorrect assessment of what is really capable of). These studies continued for 64 hours (two nights without sleep) with a single dose of Provigil every 15 hours.
Taking modafinil before going to bed can seriously change the sleep cycle and lead to subsequent lethargy, and can also cause side effects (worsening of mood and mental abilities). Recurrent hypersomnia is a phenomenon in which, after the end of the action of drugs against drowsiness, it tends to sleep even more than before they are taken.
Unlike amphetamine-based drugs, modafinil does not cause this phenomenon in cats, rats and mice. People who did not sleep for 64 hours and took modafinil, this phenomenon is also not seen, in contrast to the results when taking D-amphetamine. Provigil does not cause recurrent hypersomnia. Exacerbation of attention is observed with sleep deprivation for 10-12 hours after a single intake of 300 mg of modafinil, which is equivalent to 20 mg of D-amphetamine.
The dose of Provigil 300 mg from drowsiness is equivalent to a 20 mg dose of D-amphetamine. The brain cycle of sleep is the balance of the “ascending activating system”, consisting of activating neurotransmitters (catecholamines, acetylcholine, nuts, etc.) and neurotransmitters (GABA, galanin), which suppress stimulation and contribute to falling asleep. Changing levels of activation and suppression of neurotransmitters forms a kind of cycle “switch-on-switch”.
In general, the regulation of the cycle of vivacity and rest depends, on the one hand, on the daily biorhythm caused by the suprachiasimatic nucleus, and on the other hand, on the homeostatic need for sleep that occurs during wakefulness. Provigil is able to contact with various stimulant systems, including serotonergic, noradrenergic, dopaminergic, glutaminergic, histaminergic, oroxynergic and GABAergic pathways of metabolism.
During some studies, Provigil was used in the treatment of a number of other diseases, and it was found that the side effect of insomnia lasted longer than in the placebo group, and that modafinil taken at bedtime did not let the experiment participants fall asleep. The use of modafinil promotes mental stress.

Memory and thought processes
In healthy people, when taking 100-200 mg of Provigil 2 hours before the test (arithmetic test), the memory properties, spatial-visual planning and reaction rate were improved. Short-term memory and accuracy of information processing improved after taking 200 mg of modafinil. In addition to the above, improvements are observed when performing the task as a whole – increasing motivation, enjoying the work done.
In methamphetamine-dependent cognitive impairments, the dose of Provigil in 400 grams, broken down for 3 days, is able to improve the properties of short-term memory, which was previously not possible, but a single dose of 200 mg modafinil is not capable of causing such an effect.

Impact on the appetite
Researchers who condemn the drug, sometimes report a violation of appetite as a side effect in 16% (164 people). Some researchers consider this fact the cause of weight loss within a week, however, statistically.

Addiction
Provigil is unable to activate the neural pathways of metabolism, which occurs with dependence, and therefore it is believed that the drug has a low threshold of habituation with respect to other similar drugs. It is unlikely that modafinil will be used as a drug in the environment of drug addicts.
Provigil is able to help alleviate the breakdown in methamphetamine-dependent, alcoholics and gamers, but the effect of exposure varies. Provigil also reduces the impulsivity of the dependent, but this effect only affects the subjects whose impulse threshold before the experiments was already low.

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Multiple sclerosis
One-time administration of ardomofinil (250 mg) in patients with multiple sclerosis showed improved mnemonic reproduction, the effect was comparable to the placebo effect, but the fatigue, the ability to focus and the processing speed of the information did not affect the drug in any way.

Precautionary measures. Toxicology
The tests revealed the following adverse effects of the drug – headache, dizziness, diuresis, heart palpitations, tachycardia, anxiety, nervousness, gastrointestinal problems such as nausea, and dry mouth and abdominal pain. Apart from the above, Provigil is considered a well tolerated drug.
Common side effects of modafinil include insomnia and decreased appetite.

Provigil side effects
Side effects Provigil, as a rule, associated with stimulation of the central nervous system and may include nervousness, insomnia, trembling, euphoria, personality changes and arousal. The drug can also cause gastrointestinal disorders such as nausea, vomiting, abdominal pain, dry mouth, anorexia and headache.
Hypertension, heart palpitations or abnormal heart rhythms may also occur.
In rare cases, an allergic rash, an increase in alkaline phosphatase or a disorder in voluntary movements may occur.

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INSTRUCTIONS FOR USE FILDENA SUPER ACTIVE 100 MG

FILDENA SUPER ACTIV – IT IS NOT STANDARD GENERIC, REPEATING THE EXACT FORMULA OF BRAND PREPARATION. PREPARATION, BETWEEN POWERFUL FORMULA FOR SILDENAFIL, CONTAINS ANOTHER AND INTEGRATED HERBAL COMPLEX AND ACTIVES MUCH PRODUCTIVE CONVENTIONAL SILDENAFILE.

This tool, in addition to the powerful formula of the Sildenafil already familiar to you, also contains a whole complex of medicinal herbs that are synergists of sildenafil, which in the end provides not only a more prolonged intimate contact, but also works much more efficiently than Sildenafil in a standard dosage.

As soon as the cavernous bodies of the penis are filled with blood, immediately the penis grows in size and becomes firm, so the usual mechanism of erection occurs. In order for the blood flow to go directly to the penis, sexual stimulation is needed, then the internal humoral factors of the organism come into play, namely, the cyclic hyanosine monophosphate or CGMP is involved. It is produced under the action of nitric oxide and is the key point of the appearance of a long and quality erection.

CGMP completely controls the amount and force of blood flow to the reproductive system, as well as controls its outflow, so the action of sildenafil is aimed at increasing CGMP by blocking another active enzyme PDE5, which contributes to the destruction of CGMP. It is Sildenafil and medicinal herbs that are part of the Sildenafil Super Active actively prevent the decomposition of CGMP into fractions, contribute to its accumulation in the body and, accordingly, a longer erection.

Sildenafil capsules is a new generation drug, it is provided with a more productive formula capable of more effectively solving male problems associated with potency. Active medicinal herbs safely enhance the positive effect of the drug, allowing you to help even in the most difficult situations associated with violations of erectile dysfunction.

Advice to a doctor before using Fildena Super Active 100 mg is necessary, especially if the use of the drug occurs for the first time. It is necessary to evaluate the possibilities of your body and the compatibility of sildenafil and medicinal herbs that are part of the Fildena Active Super Active 100mg and the drugs you use for other diseases.

Possible restrictions on taking the drug:
☞ Any manifestations of allergic reactions to the ingredients of the product;
☞ Limitations to physical and sexual loads;
The intake of nitrate preparations in any form is incompatible with the use ☞ of Fildena Super Active 100 mg;
☞ With a predisposition to bleeding;
At the expressed infringements of work of internal organs.
Use capsules once a day at a daily dosage of 100 mg. It should be noted that the capsules are much faster than tablets, so use Sildenafil in capsules, not for 40-50 minutes, as happens when taking a standard tablet form, but 20-25 minutes before sexual intercourse. Medicinal herbs that are part of the drug even more contribute to the rapid onset of a positive effect, so the drug Sildenafil capsules is productive in the most difficult situations.

The main advantages of the Fildena Super Active 100 mg (capsules):
☞ Capsules contribute to a faster onset of a positive result, which is especially useful for unplanned sexual intercourse;
☞ Active substance Sildenafil in combination with herbs, enhancing its effect, provides potent potency for a longer period;
☞ Medicinal herbs help quickly cope with stressful situations, increasing vitality;
☞ Stimulate spermatogenesis.
When using Fildena Super Active at a dosage of 100 mg, negative effects are observed in about 15% of cases. This percentage can be greatly increased if you take the drug in combination with alcohol or exceed the daily dosage equal to 100 mg, so the use of the Fildena Active Super Active should not be accompanied by potentially dangerous actions, for example, driving the car until you know exactly how the drug acts individually on you.

Dizziness or even loss of consciousness can occur when consuming hot drinks, being in the heat or at elevated body temperature. Once you feel bad, you should sit or lie down, in case the symptoms become worse, you need to seek medical help.

Other frequent side effects will be redness of the face and neck area, due to a sharp flow of blood to the face area. Also, one in seven patients observes the inability to distinguish between blue and green colors, as well as dyspepsia. In general, with strict adherence to dosage, the drug is well tolerated without causing side effects, especially with repeated administration.

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