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Viramune Suspension
  • Professionals
  • FDA PI

Viramune Suspension

Generic name:nevirapine
Dosage form: tablet, oral suspension
Drug class:NNRTIs

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS

HEPATOTOXICITY:

Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with VIRAMUNE. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm3, including pregnant women receiving VIRAMUNE in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with VIRAMUNE use can occur in both genders, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking VIRAMUNE for post-exposure prophylaxis (PEP). Use of VIRAMUNE for occupational and non-occupational PEP is contraindicated [see Contraindications (4)]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue VIRAMUNE and seek medical evaluation immediately [see Warnings and Precautions (5.1)].

SKIN REACTIONS:

Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE. These have include...