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 aged 15 days and older. 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, blocking RNA-dependent 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 cytochrome P450 isoenzymes (CYP3A4 and CYP2B6)
- Excretion: Primarily renal (≈80%) and fecal (≈10%)
Benefits
- Significantly reduces HIV-1 RNA viral load in treatment-naïve and experienced patients
- Increases CD4+ T-cell counts, supporting immune reconstitution
- Convenient once-daily dosing after initial lead-in period
- Available in multiple formulations for flexible dosing across age groups
- Demonstrated long-term durability in combination antiretroviral therapy (cART)
- Lower pill burden compared to some alternative regimens
Common use
Viramune is used as part of combination antiretroviral therapy for the treatment of HIV-1 infection. It is typically prescribed for adult and pediatric patients with confirmed HIV-1 who have not previously received nevirapine. It may be used in both treatment-naïve and treatment-experienced individuals, provided there is no documented resistance to nevirapine. Viramune is often included in first-line regimens due to its efficacy, tolerability, and dosing convenience after the initial 14-day lead-in period.
Dosage and direction
Adults:
The initial dose is one 200 mg tablet once daily for 14 days (lead-in period). If no rash or other significant adverse events occur, increase to one 200 mg tablet twice daily.
Pediatric patients (15 days and older):
Dosing is based on body surface area (BSA) or body weight. Oral suspension is available for younger children or those unable to swallow tablets. Consult prescribing information for detailed pediatric dosing tables.
Administration:
May be taken with or without food. Tablets should be swallowed whole; do not crush, chew, or break. Shake oral suspension well before each use.
Precautions
- Severe and potentially fatal hepatotoxicity and skin reactions have been reported. Monitor liver function tests (LFTs) and clinical status closely, especially during the first 18 weeks.
- Discontinue immediately if signs of hepatitis, hypersensitivity, or severe skin reactions occur.
- Use with caution in patients with hepatic impairment (Child-Pugh Class B or C).
- Women with CD4+ counts >250 cells/mm³ and men with CD4+ counts >400 cells/mm³ are at increased risk of hepatic events.
- Not recommended as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens.
Contraindications
- Hypersensitivity to nevirapine or any component of the formulation.
- Moderate to severe hepatic impairment (Child-Pugh Class B or C).
- Use in patients who have experienced previous clinically significant hepatic events or severe skin reactions while on nevirapine.
- Concomitant use with rifampin-based regimens for tuberculosis unless clearly indicated and closely monitored.
- Use in patients with pre-existing liver disease unless potential benefit outweighs risk.
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%): Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatitis, fulminant hepatitis, hypersensitivity reactions, immune reconstitution inflammatory syndrome (IRIS).
Drug interaction
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may decrease nevirapine concentrations.
- Nevirapine may decrease concentrations of: methadone, ethinyl estradiol, ketoconazole, itraconazole, protease inhibitors (e.g., atazanavir, lopinavir).
- Nevirapine may increase concentrations of: efavirenz (use with caution).
- Avoid concomitant use with St. John’s wort.
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.
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 includes supportive measures and monitoring of vital signs and clinical status. Hemodialysis is unlikely to remove significant amounts of nevirapine due to high protein binding.
Storage
Store at 20–25°C (68–77°F); excursions permitted between 15–30°C (59–86°F). Keep tablets in the original container with the cap tightly closed. Protect from light and moisture. Oral suspension should be stored at room temperature; discard any unused portion 30 days after first opening.
Disclaimer
This information is intended for healthcare professionals. Viramune should be used only under the supervision of a physician experienced in the management of HIV infection. Patients must be informed of the risks of severe liver and skin reactions and advised to seek immediate medical attention if symptoms occur. Dosage adjustments or discontinuation may be necessary based on clinical and laboratory findings.
Reviews
Clinical trials and post-marketing surveillance have demonstrated Viramune’s efficacy in reducing viral load and improving immunologic parameters. In the 2NN study, nevirapine-based regimens showed non-inferiority to efavirenz-based regimens at 48 weeks. Long-term observational data support its durability, though careful patient selection and monitoring remain critical. Patient adherence is generally high due to the simplified twice-daily dosing after the initial lead-in period.