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Nevirapine indications and usage

Introduction

Nevirapine
VIRAMUNE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages
Indications And Usage

Indications And Usage

VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age [see Clinical Studies (14.1, 14.2)].

Additional important information regarding the use of VIRAMUNE XR for the treatment of HIV-1 infection:

  • Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see Boxed Warning and Warnings and Precautions (5.1)].
  • The 14-day lead-in period with immediate-release VIRAMUNE dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see Dosage and Administration (2.5) and Warnings and Precautions (5.2)].
  • If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, do not begin dosing with VIRAMUNE XR. The lead-in dosing with 200 mg once-daily immediate-release VIRAMUNE should not be continued beyond 28 days, at which point an alternative regimen should be sought.[1]
References

References

Adapted from the FDA Package Insert.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sophia Saad, Associate Editor – WikiDoc [2]