Viramune: Advanced NNRTI Therapy for Effective HIV-1 Management
| Product dosage: 200mg | |||
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Synonyms | |||
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. As a cornerstone in many antiretroviral regimens, Viramune offers a well-established efficacy and safety profile, supported by extensive clinical data and long-term use in diverse patient populations. Proper adherence and monitoring are essential to maximize therapeutic outcomes and minimize risks.
Features
- Active ingredient: Nevirapine 200 mg
- Formulation: Immediate-release tablets and oral suspension
- Mechanism: Binds directly to reverse transcriptase, inhibiting RNA- and DNA-dependent DNA polymerase activities
- Bioavailability: >90% following oral administration
- Half-life: Approximately 45 hours (single dose), 25–30 hours (multiple dosing)
- Metabolism: Hepatic, primarily via CYP3A4 and CYP2B6 isoenzymes
Benefits
- Potent viral suppression: Effectively reduces HIV-1 RNA levels, supporting long-term virologic control.
- Immune reconstitution: Helps increase and maintain CD4+ T-cell counts, reducing the risk of opportunistic infections.
- Convenient dosing: After the initial lead-in period, twice-daily dosing supports regimen adherence.
- Extensive clinical heritage: Backed by decades of real-world use and robust clinical trial data.
- Pediatric formulation availability: Oral suspension allows for weight-based dosing in children aged 15 days and older.
- Compatibility: Can be integrated into a wide range of combination antiretroviral therapies.
Common use
Viramune is used as part of combination antiretroviral therapy (cART) for the treatment of HIV-1 infection. It is typically prescribed for antiretroviral-naïve patients or as a switch option in virologically suppressed individuals. It may also be used in certain scenarios for the prevention of mother-to-child transmission of HIV, though this is off-label and requires careful risk-benefit assessment. Viramune is not active against HIV-2 and should not be used as monotherapy.
Dosage and direction
Adults: The recommended initial dose is one 200 mg tablet once daily for the first 14 days (lead-in period), followed by one 200 mg tablet twice daily. This gradual introduction helps reduce the incidence of rash.
Pediatric patients: Dosing is based on body surface area (mg/m²) or body weight. Oral suspension is available for younger children.
Viramune may be taken with or without food. Tablets should be swallowed whole; do not crush, chew, or break.
Dosage adjustment is required in patients with moderate to severe hepatic impairment. Not recommended for use in patients with severe renal impairment unless benefits clearly outweigh risks.
Precautions
- Hepatotoxicity: Severe, life-threatening hepatotoxicity has been reported. Monitor ALT, AST, and bilirubin at baseline, before dose escalation, and frequently during therapy.
- Skin reactions: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur. Discontinue immediately if severe rash or rash accompanied by systemic symptoms appears.
- Immune reconstitution syndrome: Inflammatory response to opportunistic infections may occur shortly after initiation of cART.
- Fat redistribution: Long-term use may be associated with redistribution/accumulation of body fat.
- Laboratory monitoring: Regular assessment of liver function, viral load, and CD4+ count is essential.
Contraindications
- Hypersensitivity to nevirapine or any component of the formulation.
- Moderate or severe hepatic impairment (Child-Pugh Class B or C).
- Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens.
- Co-administration with drugs highly dependent on CYP3A4 for clearance and with narrow therapeutic indices (e.g., certain antifungals, immunosuppressants).
Possible side effects
Common side effects include rash, headache, nausea, fatigue, and abnormal liver function tests.
Serious adverse reactions may include:
- Severe hepatotoxicity
- Stevens-Johnson syndrome / toxic epidermal necrolysis
- Hypersensitivity reactions
- Hematologic abnormalities
Most side effects occur within the first several weeks of therapy. Patients should be advised to report any new or worsening symptoms promptly.
Drug interaction
Nevirapine is a moderate inducer of CYP3A4 and may decrease concentrations of:
- Protease inhibitors (e.g., atazanavir, lopinavir)
- Methadone
- Oral contraceptives
- Warfarin
- Ketoconazole, itraconazole
Conversely, drugs that induce or inhibit CYP3A4 (e.g., rifampin, fluconazole) may alter nevirapine concentrations. A comprehensive medication review is essential before initiation.
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 schedule. Do not double the dose.
Overdose
There is no specific antidote for nevirapine overdose. Symptoms may include edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, and vomiting. Management is supportive and should include monitoring of vital signs and ECG. Hemodialysis is unlikely to be beneficial 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 the original container, tightly closed, and protect from light and moisture. Keep out of reach of children.
Disclaimer
This information is intended for healthcare professionals. Viramune must be prescribed by a qualified medical practitioner experienced in the management of HIV infection. Patient evaluation, including assessment of hepatic function and review of concomitant medications, is mandatory before initiation. Always follow local prescribing information and guidelines.
Reviews
Clinical studies and post-marketing surveillance have consistently demonstrated the efficacy of Viramune in reducing viral load and improving immunologic status when used as part of a combination regimen. Its role in both initial and maintenance therapy remains relevant, though careful patient selection and monitoring are critical. Long-term data support its durability in adherent patients without baseline resistance. Rash and hepatic events remain the most frequently reported adverse effects, underscoring the importance of the 14-day lead-in dosing period and ongoing laboratory surveillance.