NEVIRAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal-Agila, LLC

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 200 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEVIRAPINE- NEVIRAPINE TABLET
AMNEAL-AGILA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NEVIRAPINE.
NEVIRAPINE TABLETS, USP 200 MG 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._
FATAL AND NON-FATAL HEPATOTOXICITY (5.1)
FATAL AND NON-FATAL SKIN REACTIONS (5.2)
DISCONTINUE IMMEDIATELY IF EXPERIENCING: 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) 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
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
adult males with CD4
cell counts greater than 400 cells/mm
The 14-day lead-in period must be strictly followed; it has been
demonstrated to reduce the frequency of rash (2.4, 5.2)
DOSAGE AND ADMINISTRATION
If any patient experiences rash during the 14-day lead-in period, do
not increase dose until the rash has resolved. Do
not continue the lead-in dosing regimen beyond 28 days (2.4)
If dosing interrupted for greater than 7 days, restart 14-day lead-in
dosing (2.4)
ADULTS
(≥16 yrs)
PE DIATRIC *
(>15 days)
FIRST 14
DAYS
200 mg once daily 150 mg/m once daily
AFTER 14
DAYS
200 mg twice daily150 mg/m twice daily
*Total daily dose should not exceed 400 mg for any patient.
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg (3)
CONTRAINDICATION