HIGHLIGHTS OF PRESCRIBING INFORMATION

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), NEVIRAPINE (UNII: 99DK7FVK1H) (NEVIRAPINE - UNII:99DK7FVK1H), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)

Dostupno od:

Micro Labs Limited

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Lamivudine, nevirapine, and zidovudine tablets is indicated alone as a complete regimen or in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg. Additional important use regarding the use of nevirapine, a component of lamivudine, nevirapine, and zidovudine tablets, for the treatment of HIV-1 infection: - Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, lamivudine, nevirapine, and zidovudine tablets is not recommended to be initiated, unless the benefit outweighs the risk in: adult females with CD4 + cell counts greater than 250 cells per mm 3 or adult males with CD4 + cell counts greater than 400 cells per mm 3 [ see Warnings and Precautions (5.1) ]. - adult females with CD4 + cell counts greater than 250 cells per mm 3 or - adult males with CD4 + cell counts greater than 400 cells per mm 3 [ see Warnings and Pre

Proizvod sažetak:

Lamivudine, nevirapine, and zidovudine tablets contain 150 mg of lamivudine, 200 mg of nevirapine, and 300 mg of zidovudine. The tablets are white to off-white colored, capsule shaped, bevelled edged, biconvex, film-coated, debossed with “I” on one side and “47” on other side. They are available as follows. Bottles of 60 with induction seal and child-resistant closure                            NDC 42571-166-60 Storage:   Store below 30°C (86°F). Store in tight, light-resistant containers.

Status autorizacije:

New Drug Application

Uputa o lijeku

COATED
Micro Labs Limited
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MEDICATION GUIDE
lamivudine, nevirapine, and zidovudine tablets,
150 mg/200 mg/300 mg
What is the most important information I should know about lamivudine,
nevirapine, and zidovudine
tablets?
Lamivudine, nevirapine, and zidovudine 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.
Lamivudine, nevirapine, and zidovudine tablets can cause serious side
effects, including:
•
Severe liver problems. Some people taking lamivudine, nevirapine, and
zidovudine tablets and
other nevirapine-containing products may develop severe liver problems
that can lead to liver
failure and the need for a liver transplant, or death. Your liver may
become enlarge
(hepatomegaly) and you may develop fat in your liver (steatosis). If
you have liver problems, you
may get a rash.
•
Women have a higher risk of developing liver problems during treatment
with lamivudine,
nevirapine, and zidovudine tablets than men.
•
People who have abnormal liver test results before starting
lamivudine, nevirapine, and
zidovudine 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 lamivudine,
nevirapine, and zidovudine
tablets 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 lamivudine, nevirapine, and zidovudine tablets and call
your healthcare provider right awayif
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
•
tiredne

Svojstava lijeka

LAMIVUDINE, NEVIRAPINE, AND ZIDOVUDINE - LAMIVUDINE, NEVIRAPINE, AND
ZIDOVUDINE TABLET, FILM COATED
MICRO LABS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMIVUDINE, NEVIRAPINE, AND
ZIDOVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LAMIVUDINE, NEVIRAPINE,
AND ZIDOVUDINE TABLETS. LAMIVUDINE, NEVIRAPINE, AND ZIDOVUDINE,
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: XXXX
WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXOCITY, SKIN
REACTIONS,
HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE
HEPATOMEGALY,
EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FATAL AND NON-FATAL HEPATOTOXICITY HAVE BEEN REPORTED IN PATIENTS
TAKING NEVIRAPINE, A COMPONENT OF
LAMIVUDINE, NEVIRAPINE, AND ZIDOVUDINE TABLETS. DISCONTINUE
IMMEDIATELY IF CLINICAL HEPATITIS OR
TRANSAMINASE ELEVATIONS COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS
OCCUR. DO NOT RESTART
LAMIVUDINE, NEVIRAPINE, AND ZIDOVUDINE 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
LAMIVUDINE, NEVIRAPINE, AND ZIDOVUDINE 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)
HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA HAVE BEEN
ASSOCIATED WITH THE USE OF
ZIDOVUDINE, A COMPONENT OF LAMIVUDINE, NEVIRAPINE, AND ZIDOVUDINE
TABLETS. ( 5.3)
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE. (
5.4)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS