Nevirapine


Generic Medicine Info
Indications and Dosage
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.
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.
Patient Counseling Information
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.
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
Description: 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.
Pharmacokinetics:
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.
Chemical Structure

Chemical Structure Image
Nevirapine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4463, Nevirapine. https://pubchem.ncbi.nlm.nih.gov/compound/Nevirapine. Accessed Apr. 28, 2021.

Storage
Store at 25°C.
MIMS Class
ATC Classification
J05AG01 - nevirapine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
References
Anon. Nevirapine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 23/09/2020.

Anon. Nevirapine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/09/2020.

Buckingham R (ed). Nevirapine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/09/2020.

Joint Formulary Committee. Nevirapine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/09/2020.

Nevirapine 200 mg Tablets (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 23/09/2020.

Nevirapine Mylan 400 mg Prolonged-Release Tablets (Generics UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 23/09/2020.

Viramune (Boehringer Ingelheim International GmbH). MIMS Singapore. http://www.mims.com/singapore. Accessed 23/09/2020.

Viramune Tablet and Oral Suspension (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/09/2020.

Viramune XR Extended-Release Tablet (Boehringer Ingelheim Roxane Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 23/09/2020.

Viramune XR Extended-Release Tablets (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/09/2020.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
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