nevirapine tablet
1 INDICATIONS AND USAGE Nevirapine tablets, USP are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive trials, one of which (BI 1046) is described below. Additional important information regarding the use of Nevirapine tablets, USP for the treatment of HIV-1 infection: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP should not be initiated in adult females with CD4 + cell counts greater than 250 cells/mm 3 or in adult males with CD4 + cell counts greater than 400 cells/mm 3 unless the benefit outweighs the risk [ see Boxed Warning and Warnings and Precautions (5.1) ]. The 14-day lead-in period with Nevirapine tablets, USP 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [ see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ]. 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 tablets, USP are an NNRTI indicated for combination antiretroviral treatment of HIV-1 infection (1) Important Considerations: Initiation of treatment is not recommended in the following populations unless the benefits outweigh the risks (1, 5.1) adult females with CD4 + cell counts greater than 250 cells/mm 3 adult males with CD4 + cell counts greater than 400 cells/mm 3 The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency of rash (2.4, 5.2)
amneal pharmaceuticals llc
OVAL WHITE N 2
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16 HOW SUPPLIED/STORAGE AND HANDLING
NEVIRAPINE Tablets, USP, 200 mg , are supplied as white to off-white oval shaped tablets engraved “N2” with a single bisect separating ‘N’ and ‘2’ on one side and plain on the other side. They are available as follows: Bottles of 60 NDC 65162-209-06 Storage Store below 30 ° C. Protect from light. Store in a safe place out of the reach of children.
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