NEVIRAPINE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Macleods Pharmaceuticals Limited

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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  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 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

Podsumowanie produktu:

Nevirapine tablets  USP, 200 mg, are white to off white, oval, biconvex, uncoated tablets having “M” and “L” debossed on one side, with a deep score separating the “M” & “L” and “1” and “1” debossed on the other side with a breakline separating “1” and “1”. Nevirapine tablets are supplied in Bottles of 60 tablets (NDC 33342-004-09). Nevirapine tablets are supplied in unit dose packages of 60 (6x10) Unit of use tablets (NDC 33342-004-24). Nevirapine tablets are supplied in unit dose packages of 120 (12x10) Unit of use tablets (NDC 33342-004-25). Dispense in tight container as defined in the USP/NF. Storage Store between 20º to 25°C (68°F to 77°F); excursions permitted to 15°to 30°C (59° to 86°F). Store in a safe place out of the reach of children.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

NEVIRAPINE - NEVIRAPINE TABLET
Macleods Pharmaceuticals Limited
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SPL MEDGUIDE SECTION
Nevirapine Tablets
(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.
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 beginnevirapine
tablets have a higher risk of liver
problems, especially:
o Women with CD4+ counts higher than 250 cells/mm3. This group has the
highest risk.
o Men with CD4+ counts higher than 400 cells/mm3.
Stop takingnevirapine 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 n

Charakterystyka produktu

NEVIRAPINE - NEVIRAPINE TABLET
MACLEODS PHARMACEUTICALS 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. 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 tablets 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:
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/mm
• adult males with CD4 cell counts greater than 400 cells/mm (1,
5.1)
DOSAGE AND ADMINISTRATION
• The 14-day lead-in peri