Viramune buy cheap online

Order Viramune online without prescription

VIRAMUNE buy cheap online.

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

>>> Buy now Viramune <<<

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.

Customers who bought this product also bought:

Avana, cialis black, viagra, levitra,paxil, fildena, provigil, dapoxetine, bactrim, dutas, aceon, xeloda, Alli.