NEVIRAPINE- nevirapine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals, Inc.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 are not recommended to be initiated, unless the benefit outweighs the risk, in:  - adult females with CD4 + cell counts greater than 250 cells/mm 3 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

Product summary:

Nevirapine Tablets, USP 200 mg, Off-white to pale yellow colored, capsule shaped, biconvex tablets debossed with ‘H’ on one side and ‘7’ on other side with a break line on both sides. Nevirapine Tablets, USP are supplied in bottles of 60 tablets (NDC 68554-3005-0), 100 tablets (NDC 68554-3005-1), 500 tablets (NDC 68554-3005-2), 1000 tablets (NDC 68554-3005-3) Dispense in tight container as defined in the USP/NF. Storage 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Camber Pharmaceuticals, Inc.
----------
SPL MEDGUIDE SECTION
Nevirapine (neh-VEER-ah-pine)
Tablets, USP
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.
o Women have a higher risk of developing liver problems during
treatment with nevirapine tablets
than men.
o 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:
o Women with CD4 + counts higher than 250 cells/mm 3. This group has
the highest risk.
o Men with CD4 + counts higher than 400 cells/mm 3.
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.
o Women have a higher risk of developing a rash during treatment with
nevirapine tablets than men.
Stop taking nevirapine tablets and

Summary of Product characteristics

NEVIRAPINE - NEVIRAPINE TABLET
CAMBER PHARMACEUTICALS, INC.
----------
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 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. DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR TRANSAMINASE
ELEVATIONS
COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART
NEVIRAPINE
TABLETS 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 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 tablet 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 tablet 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 foll