NEVIRAPINE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEVIRAPINE (UNII: 99DK7FVK1H) (NEVIRAPINE - UNII:99DK7FVK1H)

Available from:

Roxane Laboratories, Inc.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 50 mg in 5 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

NEVIRAPINE- NEVIRAPINE SUSPENSION
NEVIRAPINE- NEVIRAPINE TABLET
ROXANE LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE TABLETS AND ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NEVIRAPINE TABLETS AND ORAL SUSPENSION.
NEVIRAPINE TABLETS, FOR ORAL USE
NEVIRAPINE ORAL SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY AND SKIN
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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DISCONTINUE IMMEDIATELY IF EXPERIENCING:
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•
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MONITORING DURING THE FIRST 18 WEEKS OF THERAPY IS ESSENTIAL. EXTRA
VIGILANCE IS WARRANTED DURING THE FIRST 6
WEEKS OF THERAPY, WHICH IS THE PERIOD OF GREATEST RISK OF THESE
EVENTS. (5)
INDICATIONS AND USAGE
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Important Considerations:
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DOSAGE AND ADMINISTRATION
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*Total daily dose should not exceed 400 mg for any patient.
ADULTS
(≥16 yrs)
PEDIATRIC PATIENTS
(≥15 days)
FIRST 14 DAYS
200 mg once daily
150 mg/m once daily
AFTER 14 DAYS
200 mg twice daily
150 mg/m twice daily
DOSAGE FORMS AND STRENGTHS
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FATAL AND NON-FATAL HEPATOTOXICITY (5.1)
FATAL AND NON-FATAL SKIN REACTIONS (5.2)
SIGNS OR SYMPTOMS OF HEPATITIS (5.1)
INCREASED TRANSAMINASES COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS
(5.1)
SEVERE SKIN OR HYPERSENSITIVITY REACTIONS (5.2)
ANY RASH WITH SYSTEMIC SYMPTOMS (5.2)
Nevirapine is an NNRTI indicated for combination antiretroviral
treatment of HIV-1 infection in adults and in pediatric
patients 15 days and older. (1)
Initiation of treatment is not recommended in the following
populations unless the benefits outweigh the risks. (1, 5.1)
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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)
If any patient experiences rash during the 14-day l