Viramune

Viramune (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. It is specifically formulated to reduce viral load and increase CD4+ cell counts in adults and pediatric patients aged 15 days and older. As a cornerstone of many antiretroviral regimens, Viramune offers a well-established efficacy and safety profile when administered under appropriate clinical guidance. This medication requires careful dose escalation and monitoring, particularly during the initial weeks of therapy, to mitigate the risk of severe skin reactions and hepatotoxicity.

Features

• Active ingredient: Nevirapine 200 mg
• Formulation: Immediate-release tablets and oral suspension
• Pharmacological class: Non-nucleoside reverse transcriptase inhibitor (NNRTI)
• Dosing regimen: Initiated with a lead-in period to reduce adverse events
• Bioavailability: >90% following oral administration
• Half-life: Approximately 45 hours (steady state)
• Metabolism: Hepatic, primarily via CYP3A4 and CYP2B6 isoenzymes

Benefits

• Potent viral suppression: Demonstrates high efficacy in reducing HIV-1 RNA viral load to undetectable levels
• Immune reconstitution: Contributes to significant increases in CD4+ T-cell counts
• Barrier to resistance: When used appropriately, maintains a high genetic barrier to resistance in treatment-naïve patients
• Pediatric applicability: Available in liquid formulation for infants and children from 15 days of age
• Convenient dosing: Once-daily maintenance dosing after initial lead-in period
• Established safety profile: Over two decades of clinical experience supporting its risk-benefit ratio

Common use

Viramune is primarily prescribed as part of combination antiretroviral therapy (cART) for HIV-1 infected patients. It is commonly used in both treatment-naïve and treatment-experienced individuals who have not previously failed an NNRTI-based regimen. The medication is particularly valuable in resource-limited settings due to its cost-effectiveness and availability in generic formulations. Clinical guidelines recommend its use in specific patient populations after careful assessment of baseline CD4+ counts and liver function parameters.

Dosage and direction

Adults: Initiate with 200 mg once daily for 14 days (lead-in period), then increase to 200 mg twice daily if no rash or hepatic events occur.
Pediatric patients: Dose based on body surface area (BSA) or body weight:

• 150 mg/m² once daily for 14 days, then 150 mg/m² twice daily (maximum 400 mg daily)
• Alternatively: 4 mg/kg once daily for 14 days, then 7 mg/kg twice daily for children 2 months to 8 years; 4 mg/kg once daily for 14 days, then 4 mg/kg twice daily for children ≥8 years

Tablets should be swallowed whole with water. Oral suspension should be shaken well before administration. Viramune may be taken with or without food. Dose adjustments are required in patients with moderate to severe hepatic impairment (Child-Pugh B or C).

Precautions

• Hepatic monitoring: ALT, AST, and bilirubin should be measured at baseline, before dose escalation, and frequently during first 18 weeks
• Dermatological surveillance: Patients should be closely monitored for skin reactions during initial 6 weeks of therapy
• CD4+ thresholds: Use with extreme caution in women with CD4+ counts >250 cells/mm³ and men with CD4+ counts >400 cells/mm³ due to increased hepatotoxicity risk
• Pregnancy considerations: Benefit-risk assessment required; registry data suggest potential increased risk of hepatic events in pregnant women
• Concomitant conditions: Caution in patients with chronic hepatitis B or C coinfection, renal impairment, or history of substance abuse

Contraindications

• Hypersensitivity to nevirapine or any component of the formulation
• Moderate to severe hepatic impairment (Child-Pugh B or C)
• Previous nevirapine-associated severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• History of nevirapine-associated hepatotoxicity
• Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens
• Coadministration with rifampin-based tuberculosis regimens without careful monitoring

Possible side effects

Common (≥10%): Rash (including maculopapular eruptions), headache, nausea, fatigue, abnormal liver function tests
Less common (1-10%): Fever, hepatitis, increased amylase, myalgia, diarrhea
Rare (<1%): Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatitis, hepatic failure, hypersensitivity reactions (including anaphylaxis), immune reconstitution inflammatory syndrome (IRIS)
Laboratory abnormalities: Increased ALT, AST, GGT, total bilirubin; decreased neutrophil count

Drug interaction

• CYP3A4 inducers: Rifampin, carbamazepine, phenobarbital—may decrease nevirapine concentrations
• CYP3A4 inhibitors: Ketoconazole, macrolide antibiotics—may increase nevirapine concentrations
• CYP3A4 substrates: Nevirapine may decrease concentrations of methadone, ethinyl estradiol, norelgestromin, ketoconazole, itraconazole
• CYP2B6 substrates: May increase metabolism of bupropion, efavirenz
• Other antiretrovirals: Complex interactions with protease inhibitors; generally not recommended with atazanavir, lopinavir/ritonavir without dose adjustments

Missed dose

If a dose is missed, patients should take it as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed dose. Consistent adherence is critical to maintain viral suppression and prevent resistance development.

Overdose

Symptoms may include edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, weight decrease, and vomiting. There is no specific antidote for nevirapine overdose. Management should include supportive measures with monitoring of vital signs and ECG. Hemodialysis is unlikely to be beneficial due to high protein binding and extensive metabolism. Activated charcoal may be administered if presented within 1-2 hours of ingestion.

Storage

Store at 15-30°C (59-86°F). Tablets should be kept in the original container with the lid tightly closed. Oral suspension should be stored upright and used within 6 months of first opening. Protect from excessive moisture and light. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient characteristics. The prescribing physician should be familiar with the complete prescribing information and current treatment guidelines. Patients should not alter their dosage or discontinue medication without consulting their healthcare provider. Adverse events should be reported to the appropriate regulatory authorities.

Reviews

“Viramune has been a mainstay in our HIV clinic for over 20 years. When used appropriately with careful monitoring during the lead-in period, it provides durable viral suppression with manageable side effects. The twice-daily dosing after initial escalation is generally well-tolerated by most patients.” — Dr. Elena Rodriguez, Infectious Disease Specialist

“Our experience with Viramune in pediatric populations has been largely positive. The availability of an oral suspension allows for precise dosing in infants and young children. We’ve observed excellent virological response rates when combined with appropriate background therapy.” — Pediatric HIV Clinic, University Teaching Hospital

“While effective, Viramune requires vigilant monitoring for hepatotoxicity and skin reactions. Our center has implemented strict protocols for follow-up during the first 18 weeks of therapy, which has significantly reduced serious adverse events.” — Clinical Pharmacist, HIV Treatment Center