NEVIRAPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla Ltd.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nevirapine 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 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)] . Teratogenic Effects Pregnancy Exposur

Product summary:

Nevirapine Tablets USP, 200 mg, are white oval shaped biconvex tablets (9.3 mm x 19.10 mm) with central break line on one side and 'N' debossed on the other side. Nevirapine Tablets USP, 200 mg are available as follows: Bottle of 60 tablets                             (NDC 53104 0166 2) Bottle of 1000 tablets                         (NDC 53104 0166 6) Storage Store at 20°C-25°C (68°F-77°F) [See USP Controlled room temperature]. Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cipla Ltd.
----------
MEDICATION GUIDE
Nevirapine Tablets USP, 200mg
(ne-VIR-a-peen)
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 any time 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 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 counts 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
symptoms:
blisters
muscle or join

Summary of Product characteristics

NEVIRAPINE- NEVIRAPINE TABLET
CIPLA LTD.
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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 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 HEPATOTOXICITYHAVE 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 frequency