Viramune

Viramune

nevirapine

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Nevirapine anhydrate
Indications/Uses
Use in combination w/ other antiretroviral agents for the treatment of HIV-1 infection.
Dosage/Direction for Use
200-mg tab Adult 1 tab daily for 1st 14 days, then 1 tab bd in combination w/ at least 2 additional antiretroviral agents. Childn per BSA: 150 mg/m2 once daily for 2 wk followed by 150 mg/m2 bd thereafter. Max: 400 mg/day. 400-mg XR tab Adult One 200-mg tab once daily for 1st 14 days followed by one 400-mg XR tab once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe hepatic dysfunction (Child-Pugh C) or pre-treatment ASAT or ALAT >5 times upper limit of normal (ULN). Do not re-administer in patients who required permanent discontinuation for severe rash, rash w/ constitutional symptoms, hypersensitivity reactions, clinical hepatitis due to nevirapine, previous ASAT/ALAT levels >5x ULN during nevirapine therapy or rapid recurrence of liver function abnormalities w/ readministration of nevirapine, herbal prep containing St. John's wort, rare hereditary conditions that may be incompatible w/ an excipient of the product.
Special Precautions
Monitor closely especially in 1st 18 wk of therapy for severe & life-threatening skin reactions & serious hepatitis or hepatic failure. Women & patients w/ higher CD4+ counts at the initiation of therapy are at greater risk of hepatic adverse events if the patient has detectable plasma HIV-1 RNA ie, a conc ≥50 copies/mL. Adhere strictly to dosage especially during 14 days lead-in period. Stop immediately if ASAT or ALAT rise to >5x ULN. Hepatic or renal dysfunction. Discontinue if severe rash or rash w/ accompanying symptoms develops. Rare hereditary condition of fructose & galactose intolerance. Pregnancy & lactation. Childn <3 yr.
Adverse Reactions
Rash, fever, nausea, headache, fatigue, somnolence, vomiting, diarrhea, abdominal pain & myalgia. Granulocytopenia; hypersensitivity; hepatitis & abnormal liver function tests.
Drug Interactions
Drugs extensively metabolised by CYP3A or CYP2B. Efavirenz, rifampicin. Ketoconazole, delavirdine, etravirine, rilpivirine, elvitegravir (in combination w/ cobicistat), ritonavir, fosamprenavir, saquinavir, atazanavir, boceprevir, telaprevir; clarithromycin, fluconazole, itraconazole, warfarin, OC's, St. John's wort.
MIMS Class
Antivirals
ATC Classification
J05AG01 - nevirapine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Viramune oral susp 50 mg/5 mL
Packing/Price
240 mL x 1's
Form
Viramune tab 200 mg
Packing/Price
60's ($427.5/box)
Form
Viramune XR tab 100 mg
Packing/Price
90's
Form
Viramune XR tab 400 mg
Packing/Price
30's
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