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This medication is used in the treatment of infection with the HIV virus (the virus that causes AIDS). It is used in combination with other HIV medications in selected patients. No cure exists for HIV infection, and the illnesses associated with your disease (infections, etc.) may continue.

Brand: Nevirapine

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: May 2024
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Viramune 200 mg
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$253.90 $2.12 $170.06 Add to cart
90 pills - 200 mg
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Product description

Drug Title

Viramune (Nevirapine)

Pharmacological action

Antiviral drug. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. Nevirapine binds directly to reverse transcriptase and blocks the activity of RNA-dependent and DNA-dependent DNA polymerase, causing destruction of the catalytic site of this enzyme. Nevirapine activity does not compete with matrix or nucleoside triphosphates. Nevirapine does not inhibit HIV-2 reverse transcriptase or eukaryotic cell DNA polymerases (such as α, β, γ or δ DNA polymerases).

HIV sensitivity in vitro

The relationship between HIV-1 sensitivity to Viramune in vitro and inhibition of HIV-1 replication in humans has not been established.

The in vitro antiviral activity of nevirapine was evaluated on peripheral blood mononuclear cells, monocytic macrophages and lymphoblast cell lines. IC50 (inhibitory concentration) values against laboratory and clinical HIV-1 isolates ranged from 10 to 100 nmol. Nevirapine activity against HIV-1 in combination with zidovudine, didanosine, lamivudine, stavudine, saquinavir, and indinavir was shown to be additive or synergistic in cell culture.


In vitro, the possibility of HIV isolates with reduced sensitivity (100-250-fold) to nevirapine was established. Genotypic analysis revealed mutations in the HIV RT gene at the 181 and/or 106 amino acid positions, depending on the virus strain and the cell line used. When nevirapine was used in combination with several other NNRTIs, the time of emergence of resistance to nevirapine, in vitro, did not change.

In phase I/II studies, phenotypic and genotypic changes in HIV-1 isolates isolated from patients receiving Viramune (n=24) or Viramune in combination with zidovudine (n=14) were monitored for 1 to ≥12 weeks.

After Viramune monotherapy for 1 week, reduced sensitivity to nevirapine in vitro was observed in isolates isolated in 3/3 of patients. In some patients (at the earliest, 2 weeks after the start of therapy), one or more mutations in the RT gene, at the 103, 106, 108, 181, 188 and 190 amino acid positions, were detected. By week 8 of Viramun® monotherapy, all patients studied (n=24) had HIV isolates with in vitro sensitivity to nevirapine that was reduced more than 100-fold compared to baseline, and one or more RT gene mutations associated with nevirapine resistance were detected. Isolates with the mutation at position 181 were isolated in 80% of patients, regardless of dose.

Viramune + zidovudine combination therapy did not change the incidence of nevirapine-resistant viruses or the degree of nevirapine resistance in vitro. However, a different type of mutation was observed in these cases, predominantly occurring at 103, 106, 188, and 190 amino acid positions. In patients (6 of 14) with initial isolates that had a natural-type RT gene, combination therapy with Viramune® + zidovudine did not delay the appearance of zidovudine-resistant RT gene mutations.




Nevirapine is well (> 90%) absorbed after oral administration. Cmax in plasma after a single dose of 200 mg nevirapine was reached after 4 hours and was 2 + 0.4 µg/ml (7.5 µmol). After multiple doses of 200 to 400 mg/day, the Cmax of nevirapine increased linearly with dose. Nevirapine basal concentrations during steady state pharmacokinetics at 400 mg/day were 4.5±1.9 µg/ml (17±7 µmol).

Intake of food, antacids or drugs whose dosage form contains an alkaline buffer (e.g., didanosine) does not affect the absorption of nevirapine.

Contraindications to use

  • Clinically significant hypersensitivity to Nevirapine or any other component of the drug.

The drug should not be administered in patients with severe liver dysfunction or in case of an initial increase in ACT or ALT levels more than 5 times the ULN, until AST/ALT values decrease (steadily) to a level that does not exceed ULN by a factor of 5.

Viramun should not be re-prescribed to patients who have previously had ACT or ALT elevations greater than 5 times the ULN during nevirapine therapy, or to patients who have experienced a recurrence of liver dysfunction after reapplication of nevirapine.

The drug should not be administered again to patients who have required its withdrawal due to the development of severe rash (including those accompanied by general symptoms), hypersensitivity reactions or development of clinically pronounced hepatitis caused by nevirapine.

Use in pregnancy and lactation

To date, there have been no fully controlled studies of Viramun® use in HIV-1-infected pregnant women. Viramun® should be used in pregnancy only when the possible benefit exceeds the potential risk to the fetus.

The safety and efficacy of Viramune to prevent HIV-1 transmission from mother to child has been established when used as part of a regimen that included a single oral dose of 200 mg by the mother at delivery and a single oral dose of 2 mg/kg body weight to the newborn within 72 hours after birth.

In accordance with the recommendation that HIV-infected mothers should not breastfeed their newborns to avoid the risk of postnatal HIV transmission, mothers receiving Viramun therapy should stop breastfeeding.

Use in patients with liver dysfunction

This medicine is not administered in patients with severe liver dysfunction or in case of ACT or ALT level increasing more than 5 times higher than the upper limit of normal, until AST/ALT level decreases (steadily) up to 5 times higher than the upper limit of normal. Viramun® should not be repeatedly administered to patients with ACT or ALT elevations greater than 5 times the upper limit of normal values during previous therapy with nevirapine or to patients with recurrence of liver dysfunction after reapplication of nevirapine.

Use in impaired renal function

Pharmacokinetic studies conducted in patients with impaired renal function who have been on hemodialysis have shown that adjunctive therapy with Viramun with an added dose of 200 mg after each dialysis session may help to compensate for the effects of dialysis on Viramun clearance. Thus, no changes in Viramune dosing are required in patients with CK greater than 20 mL/min.

Administration in children

It is possible to use according to the indication.

Indications for Viramun

  • Treatment of HIV-infection in combination with other antiretroviral drugs used to treat HIV-1 infection (Viramun monotherapy rapidly and almost always produces resistant strains of the virus, therefore Viramun should always be used in combination with at least two other antiretroviral drugs);
  • to prevent mother-to-child transmission of HIV-1, in pregnant women who do not receive antiretroviral therapy during delivery. Viramun is indicated and may be used in the mother as monotherapy, as a single dose taken orally during delivery, and in the child, also as a single dose given orally after birth. In order to minimize the risk of HIV-1 transmission to the baby, combination therapy in the mother before delivery is recommended when possible.

Dosing regimen

In adults, the drug is given initially in a dose of 200 mg once daily for the first 14 days (this has been shown to reduce the incidence of rash), then the dose is increased to 200 mg twice daily (in combination with at least two additional antiretrovirals). If combination therapy is used, the dosing and monitoring guidelines recommended by the manufacturers must be followed.

In children aged 2 months to 8 years, the drug is administered at a dose of 4 mg/kg body weight once daily for the first 14 days, then at 7 mg/kg body weight twice daily. The recommended dose for children aged 8 years and older is 4 mg/kg 1 time/day for the first 14 days, then 4 mg/kg 2 times/day.

The total daily dose in any patient should not exceed 400 mg.

Patients should be advised to take Viramun daily as directed. If a patient misses a dose, the next dose should not be doubled, the next dose should be taken as soon as possible.

Biochemical tests, including liver function tests, should be performed before starting Viramun and at appropriate intervals during therapy.

Patients who experience a rash during the 14-day initial period of daily dosing of 200 mg/day should not increase the dose until the rash disappears.

Patients who have interrupted Viramune for more than 7 days should resume the recommended dosing regimen: take the drug at a dose of 200 mg (4 mg/kg/day in children) once daily (initial period) and then 200 mg twice daily (4 mg/kg or 7 mg/kg twice daily in children, depending on age).

To prevent HIV transmission from mother to child, a single administration of Viramun to a pregnant woman during labor (as soon as possible after the start of labor) at a dose of 200 mg followed by a single oral administration to the newborn within 72 hours after birth at a dose of 2 mg/kg body weight is recommended. If the mother took Viramun less than 2 hours before delivery, the newborn should receive the first dose (2 mg/kg) immediately after birth and the second dose (2 mg/kg) within 24-72 hours after the first.