This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
HIV infection

Adult: Combined with other antiretrovirals: 200 mg once daily for the first 14 days; increase to 200 mg bid if rash does not develop. Interrupting the treatment for >7 days necessitate reintroduction at a lower dose for the first 14 days.
Child: Combined with other antiretrovirals: 2 mth to 8 yr: 4 mg/kg once daily for the first 14 days; increase to 7 mg/kg bid if no rash is present. 8-16 yr: 4 mg/kg once daily for 14 days followed by 4 mg/kg bid. Max: 400 mg daily. Interrupting the treatment for >7 days necessitate reintroduction at a lower dose for the first 14 days.

Renal Impairment

Haemodialysis: A further 200-mg dose is recommended after dialysis.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Lactation. Severe hepatic impairment.

Special Precautions

Pregnancy. Interrupt treatment if severe hepatotoxicity or life-threatening skin reactions develop. Renal or hepatic insufficiency. Monitor liver function periodically.

Adverse Reactions

Skin rash, nausea, vomiting, headache, abnormal LFT, fatigue, diarrhoea, abdominal pain.
Potentially Fatal: Severe and life-threatening hepatotoxic and skin reactions.

Pregnancy Category (US FDA)

PO: B

Overdosage

Symptoms: Oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, wt loss. Management: No known antidote.

Drug Interactions

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

Food Interaction

Reduced serum levels with St John's wort.

Action

Description: 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.
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract; peak plasma concentrations after 4 hr (oral).
Distribution: Crosses the placenta; enters breast milk. Protein-binding: Approx 60%.
Metabolism: Hepatic by microsomal enzymes.
Excretion: Via urine (as glucuronide conjugates of the hydroxylated metabolites).

Storage

Store at 15-30°C (59-86°F).

MIMS Class

Antivirals

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Nevirapine - oral