Nevirapine

Nevirapine is indicated for  combination antiretroviral treatment of HIV-1 infection in adults and in pediatric patients 15 days and older.

Additional important information regarding the use of Nevirapine for the treatment of HIV-1 infection:

• Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm³ or in adult males with CD4+ cell counts greater than 400 cells/mm³ unless the benefit outweighs the risk.
• The 14-day lead-in period with Nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash.
• If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.

Nevirapine is a non-nucleoside reverse transcriptase inhibitor that acts against HIV-1. It binds directly to reverse transcriptase and thereby blocks the RNA-dependent and DNA-dependent DNA polymerase activities by disrupting the enzyme's catalytic site.

Adult Patients: The recommended dose for Nevirapine is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer's recommended dosage and monitoring should be followed.

Pediatric Patients: The recommended oral dose for pediatric patients 15 days and older is 150 mg/m² once daily for 14 days followed by 150 mg/m² twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.

Mutually increased levels effects when used with drugs extensively metabolised by CYP3A. Reduced levels/effects of methadone.

Hypersensitivity. Lactation. Severe hepatic impairment.

Skin rash, nausea, vomiting, headache, abnormal LFT, fatigue, diarrhoea, abdominal pain.

Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Nevirapine is excreted in breast milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving Nevirapine.

There is no known antidote for Nevirapine overdosage. Cases of Nevirapine overdose at doses ranging from 800 to 1800 mg per day for up to 15 days have been reported. Patients have experienced events including edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, and weight decrease. All events subsided following discontinuation of Nevirapine.

Store at 15-30° C

Nevirapine 200mg