NEVIRAPINE- nevirapine tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Micro Labs Limited

INN (nemzetközi neve):

NEVIRAPINE

Összetétel:

NEVIRAPINE 200 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Nevirapine tablet 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 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 3 or - adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnings and Precautions (5.1)] . Nevirapine is 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 Po

Termék összefoglaló:

Nevirapine Tablets USP, 200 mg are White to off-white, oval, biconvex tablet, marked on one side as “I” and “11” separated with a breakline and plain on other side. Pack style: Blister Pack of 60 (6 x 10) Unit-dose Tablets Packing configuration: 10 Tablets packed in a Blister and such 6 Blister are packed in one Carton (NDC code: 42571-131-29). Pack style: HDPE Bottle pack of 60s Tablets (NDC code: 42571-131-60). Dispense in tight container as defined in the USP/NF.   Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

NEVIRAPINE - NEVIRAPINE TABLET
Micro Labs Limited
----------
MEDICATION GUIDE
Nevirapine (ne-VIR-a-peen) tablets, USP
What is the most important information I should know about nevirapine?
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 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 counts when they begin nevirapine
have a higher risk of liver problems,
especially:
•
Women with CD4 + counts higher than 250 cells/mm 3. This group has the
highest risk.
•
Men with CD4 + counts higher than 400 cells/mm 3.
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:
•
yellowing of your skin or whites of your
•
dark (tea colored) urine
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 than men.
Stop taking nevirapine and call your doctor right away if you get

Termékjellemzők

NEVIRAPINE - NEVIRAPINE TABLET
MICRO LABS 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 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 followed; it has been
demonstrated to reduce