NEVIRAPINE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Aurobindo Pharma Limited

Designación común internacional (DCI):

NEVIRAPINE

Composición:

NEVIRAPINE 200 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit outweighs the risk, in:  - adult females with CD4+ cell counts greater than 250 cells/mm3 or  - adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)]. Nevirapine tablets are contraindicated: - in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions (5.1)  and Use in Specific Populations (8.7) ] . - for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions (5.1)]. Pregnancy Exposure Registry There is a p

Resumen del producto:

Nevirapine Tablets USP, 200 mg are white to off-white, oval shape, biconvex tablets, one side debossed with “C” and “35”, with a single bisect separating “C” and “35”.  The other side has a single bisect.       Bottle of 60 Tablets                               NDC 65862-027-60       Carton of 6 x 10 Unit-dose Tablets       NDC 65862-027-10 Dispense in tight container as defined in the USP/NF. Storage Nevirapine Tablets, USP should be stored at 20 ° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

NEVIRAPINE - NEVIRAPINE TABLET
Aurobindo Pharma Limited
----------
MEDICATION GUIDE Nevirapine Tablets, USP
(ne vir' a peen)
What is the most important information I should know about nevirapine
tablets?
Nevirapine tablets can cause severe liver and skin problems that may
lead to death. These problems can
happen at any time during treatment, but your risk is higher during
the first 18 weeks of treatment.
Nevirapine tablets can cause serious side effects, including:
•
Severe liver problems. Some people taking nevirapine tablets may
develop severe liver problems that
can lead to liver failure and the need for a liver transplant, or
death. If you have liver problems, you
may get a rash.
•
Women have a higher risk of developing liver problems during treatment
with nevirapine tablets than
men.
•
People who have abnormal liver test results before starting nevirapine
tablets and people with
hepatitis B or C also have a greater risk of getting liver problems.
People who have higher CD4+ cell counts when they begin nevirapine
tablets have a higher risk of liver
problems, especially:
•
Women with CD4+ counts higher than 250 cells/mm3. This group has the
highest risk.
•
Men with CD4+ counts higher than 400 cells/mm3.
Stop taking nevirapine tablets and call your doctor right away if you
have any of the following symptoms of
liver problems with or without a skin rash:
•
dark (tea colored) urine
•
yellowing of your skin or whites of your eyes
•
light-colored bowel movements (stools)
•
fever
•
feeling sick to your stomach (nausea)
•
feel unwell or like you have the flu
•
pain or tenderness on your right side below your ribs
•
tiredness
•
loss of appetite
•
Severe skin reactions and rash. Some skin reactions and rashes may be
severe, life-threatening, and in
some people, may lead to death. Most severe skin reactions and rashes
happen in the first 6 weeks of
treatment with nevirapine tablets.
•
Women have a higher risk of developing a rash during treatment with
nevirapine tablets than men.
Stop tak

Ficha técnica

NEVIRAPINE - NEVIRAPINE TABLET
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NEVIRAPINE TABLETS.
NEVIRAPINE TABLETS, 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 HAVE BEEN REPORTED IN PATIENTS
TAKING NEVIRAPINE.
DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR TRANSAMINASE
ELEVATIONS COMBINED
WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART NEVIRAPINE
AFTER
RECOVERY. (5.1)
FATAL AND NON-FATAL SKIN REACTIONS, INCLUDING STEVENS-JOHNSON
SYNDROME, TOXIC
EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS, HAVE BEEN
REPORTED.
DISCONTINUE IMMEDIATELY IF SEVERE SKIN REACTIONS, HYPERSENSITIVITY
REACTIONS, OR ANY
RASH WITH SYSTEMIC SYMPTOMS OCCUR. CHECK TRANSAMINASE LEVELS
IMMEDIATELY FOR ALL
PATIENTS WHO DEVELOP A RASH IN THE FIRST 18 WEEKS OF TREATMENT. DO NOT
RESTART
NEVIRAPINE AFTER RECOVERY. (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. (5.1, 5.2)
INDICATIONS AND USAGE
Nevirapine is an NNRTI indicated in combination with other
antiretroviral agents for the treatment of
human immunodeficiency virus (HIV-1) infection in adults and pediatric
patients 15 days and older. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in
controlled and uncontrolled trials,
nevirapine is not recommended to be initiated, unless the benefit
outweighs the risk, in:
adult females with CD4 cell counts greater than 250 cells/mm
adult males with CD4 cell counts greater than 400 cells/mm (1, 5.1)
DOSAGE AND ADMINISTRATION
The 14-day lead-in period must be strictly followed; it has been
demonstrated to reduce the frequenc