NEVIRAPINE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Strides Pharma Science Limited

INN (Nome Internazionale):

NEVIRAPINE

Composizione:

NEVIRAPINE 200 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Nevirapine tablets, USP is 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, USP 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, USP 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 Th

Dettagli prodotto:

Nevirapine Tablets, USP, 200 mg , are supplied as white to off-white oval shaped tablets engraved "N2" with a single bisect separating 'N' and '2' on one side and plain on the other side. They are available as follows: Bottles of 60 NDC 64380-709-03 Storage Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Strides Pharma Science Limited
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MEDICATION GUIDE
Nevirapine Tablets
(ne-VIR-a-peen) tablets, USP
.
What is the most important information I should know about Nevirapine?
Nevirapine can cause severe liver and skin problems that may lead to
death. These problems can happen at
anytime during treatment, but your risk is higher during the first 18
weeks of treatment.
Nevirapine 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 than men.
•
People who have abnormal liver test results before starting Nevirapine
and people with hepatitis B or
C also have a greater risk of getting liver problems.
People who have higher CD4+ cell count when they begin Nevirapine 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 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.
•
Women have a higher risk of developing a rash during treatment with
Nevirapine than men.
Stop taking Nevirapine and call your doctor right away if you get a
rash with any of the following

Scheda tecnica

NEVIRAPINE - NEVIRAPINE TABLET
STRIDES PHARMA SCIENCE LIMITED
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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
TABLETS, USP. DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR
TRANSAMINASE ELEVATIONS
COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART
NEVIRAPINE
TABLETS, USP 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 TABLETS, USP AFTER RECOVERY. (5.2)
MONITORINGDURING 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 tablets, USP are 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: (1)
Based on serious and life-threatening hepatotoxicity observed in
controlled and uncontrolled trials,
Nevirapine tablets, USP is not recommended to be initiated, unless the
benefit outweighs the risk, in: (1)
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 per