Nevirapine


Full Generic Medicine Info
Dosage/Direction for Use

Oral
HIV-1 infection
Adult: In combination with other antiretroviral agents: Initially, 200 mg once daily for 14 days. Maintenance: As conventional tab: 200 mg bid. As extended release tab: 400 mg once daily.
Child: As conventional tablet or suspension in combination with other antiretroviral agents: Initially, 150 mg/m2 once daily for 14 days. Maintenance: 150 mg/m2 bid or as extended-release tab 400 mg once daily. ≥16 years or weighing ≥50 kg or with BSA >1.25 m2: Same as adult dose.
Renal impairment: Patient on haemodialysis: An additional 200 mg should be given after dialysis treatment.
Hepatic impairment: Moderate to severe (Child Pugh class B or C): Contraindicated.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of severe rash or rash accompanied by constitutional symptoms or clinical hepatitis caused by nevirapine. Use in postexposure prophylaxis (PEP) regimens. Moderate to severe hepatic impairment (Child Pugh class B or C). Lactation. Concomitant use with St. John's wort.
Special Precautions
Patient with high CD4+ counts (>250 cells/mm3 in females or >400 cell/mm3 in males), chronic hepatitis B or C. Mild hepatic impairment (Child-Pugh class A). Pregnancy. Patient Counselling This drug may cause fatigue, if affected, do not drive or operate machinery. Monitoring Parameters Monitor for signs of adverse skin reactions and hepatotoxicity for the first 18 weeks of treatment, particularly in the first 6 weeks. Monitor CBC, viral load; liver function at baseline then prior and after 2 weeks of dose escalation. Immediately evaluate transaminases level in patients with rash.
Adverse Reactions
Significant: Immune reconstitution syndrome, fat redistribution (e.g. central obesity, buffalo hump, peripheral wasting, facial wasting, breast enlargement, cushingoid appearance), rhabdomyolysis, elevated transaminase. Blood and lymphatic system disorders: Granulocytopenia, neutropenia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain. General disorders and administration site conditions: Fever, fatigue. Hepatobiliary disorders: Hepatitis. Investigations: Increased serum cholesterol, LDL cholesterol, serum alanine aminotransferase, serum aspartate aminotransferase, amylase. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache.
Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions with rash and organ dysfunction, hepatotoxicity.
Drug Interactions
Increased risk of toxicity with efavirenz. May decrease serum concentration of atazanavir and lopinavir, boceprevir, telaprevir, clarithromycin, and methadone. Increased exposure with fluconazole.
Food Interaction
Reduced plasma concentrations with St. John's wort.
Action
Nevirapine, a non-nucleoside reverse transcriptase inhibitor which binds directly to reverse transcriptase which inhibits the RNA-dependent and DNA-dependent DNA polymerase activities including HIV-1 replication.
Absorption: Readily absorbed from the gastrointestinal tract. Bioavailability: 93% (conventional tab); approx 75% (extended release tab); 91% (oral solution). Time to peak plasma concentration: 4 hours (conventional tab/oral solution); approx 24 hours (extended release tab).
Distribution: Crosses placenta, enters breast milk and distributed in the CSF. Volume of distribution: 1.2 L/kg. Plasma protein binding: Approx 60%.
Metabolism: Extensively metabolised in the liver by CYP3A4 and CYP2B6 into several hydroxylated metabolites; undergoes enterohepatic recycling.
Excretion: Mainly via urine (approx 81% as metabolites; <3% as unchanged drug); faeces (approx 10%). Elimination half-life: 45 hours as single dose; decreases to 25-30 hours after multiple doses.
Storage
Oral: Store at 25°C.
CIMS Class
Antivirals
ATC Classification
J05AG01 - nevirapine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by CIMS based on nevirapine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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