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 in antiretroviral therapy (ART), Viramune targets the reverse transcriptase enzyme, critical for viral replication, thereby impeding the progression of HIV infection. Its well-established efficacy and pharmacokinetic profile make it a viable option within comprehensive treatment regimens, subject to appropriate clinical monitoring and adherence to dosing guidelines.

Features

• Active pharmaceutical ingredient: Nevirapine 200 mg
• Available in immediate-release tablet and oral suspension formulations
• Bioavailability approximately 90% following oral administration
• Metabolized primarily by the cytochrome P450 isozymes CYP3A4 and CYP2B6
• Half-life of 25–30 hours in adults, allowing for twice-daily dosing
• Demonstrated efficacy in treatment-naïve and treatment-experienced patients

Benefits

• Effectively suppresses HIV-1 replication through non-competitive inhibition of reverse transcriptase
• Contributes to immunologic recovery as evidenced by increased CD4+ cell counts
• Compatible with a wide range of other antiretroviral agents for tailored combination therapy
• Available in multiple formulations to support adherence across diverse patient populations
• Supported by extensive clinical data demonstrating durable virologic response
• May be used in certain scenarios for prevention of mother-to-child transmission (under specific guidelines)

Common use

Viramune is indicated as part of combination antiretroviral therapy for the treatment of HIV-1 infection. It is used in both treatment-naïve and treatment-experienced patients who have not previously failed an NNRTI-based regimen. In certain circumstances, it may also be utilized for the prevention of maternal-fetal HIV transmission, though this is off-label in some regions and requires careful risk-benefit assessment.

Dosage and direction

Adults: The recommended initiation dose is one 200 mg tablet once daily for the first 14 days (lead-in period), followed by one 200 mg tablet twice daily thereafter. This gradual introduction is critical to reducing the risk of skin rash and hepatotoxicity.
Pediatric patients: Dosing is based on body surface area (mg/m²) or body weight. Consult official prescribing information for detailed pediatric dosing tables.
Administration: Tablets may be taken with or without food. Oral suspension should be shaken gently before use and administered using an appropriate measuring device.

Precautions

• Hepatic enzyme elevations and clinical hepatitis have been reported. Monitor ALT, AST, and bilirubin at baseline, before dose escalation, and frequently during the first 18 weeks.
• Severe and life-threatening skin reactions, including Stevens-Jinson syndrome and toxic epidermal necrolysis, have occurred. Discontinue immediately if severe rash or rash accompanied by constitutional symptoms appears.
• Immune reconstitution inflammatory syndrome (IRIS) may occur during initial treatment.
• Use with caution in patients with renal impairment; no dose adjustment is required for mild to moderate impairment, but monitoring is advised.
• Women with CD4+ counts >250 cells/mm³ and men with CD4+ counts >400 cells/mm³ are at increased risk of hepatic events.

Contraindications

• Hypersensitivity to nevirapine or any component of the formulation.
• Use in patients with moderate to severe hepatic impairment (Child-Pugh B or C).
• As part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens.
• Co-administration with rifampin in patients with prior virologic failure on an NNRTI-containing regimen.

Possible side effect

Common (≥10%): rash, headache, nausea, fatigue, abnormal liver function tests.
Less common (1–10%): fever, vomiting, diarrhea, abdominal pain, myalgia.
Serious but rare (<1%): severe hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions, granulocytopenia.

Drug interaction

• Induces CYP3A4 and may decrease concentrations of: methadone, ethinyl estradiol, ketoconazole, itraconazole, protease inhibitors (except possibly boosted regimens), and some anticonvulsants.
• Concentrations may be decreased by: rifampin, rifabutin, St. John’s wort.
• Concentrations may be increased by: fluconazole, macrolide antibiotics.
• Use with other hepatotoxic drugs increases risk of liver injury.

Missed dose

If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one.

Overdose

Symptoms may include edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. There is no specific antidote. Management involves supportive care and monitoring of vital signs, hepatic function, and general symptomology. Hemodialysis is unlikely to be effective due to high protein binding.

Storage

Store at 20–25°C (68–77°F); excursions permitted between 15–30°C (59–86°F). Keep in original container, tightly closed. Protect from light and moisture. Keep oral suspension at room temperature; do not freeze. Discard any unused suspension 6 months after first opening the bottle.

Disclaimer

This information is intended for healthcare professionals. It is not exhaustive and does not replace professional medical advice, diagnosis, or treatment. Always consult the full prescribing information and clinical guidelines before initiating therapy. Dosage and administration must be individualized based on patient status, concomitant medications, and treatment response.

Reviews

Clinical trials and post-marketing surveillance have consistently demonstrated the efficacy of Viramune in reducing viral load and improving immunologic parameters when used as part of a combination ART regimen. Key studies such as the INCAS and BI 1090 trials established its role in treatment-naïve adults, with durable response observed over extended follow-up. Real-world evidence supports its utility in resource-limited settings due to its affordability and dosing schedule. However, careful patient selection and adherence to monitoring protocols are emphasized in all major treatment guidelines to mitigate risks of hepatotoxicity and cutaneous reactions.