ZIDOVUDINE- zidovudine tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)

थमां उपलब्ध:

Mylan Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

ZIDOVUDINE

रचना:

ZIDOVUDINE 300 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Zidovudine tablets USP, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.3)]. The indication is based on a dosing regimen that included three components: Points to consider prior to initiating zidovudine tablets in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: Zidovudine tablets are contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. In humans, treatment with zidovudine during pregnancy reduced the rate of maternal-fetal HIV-1 transmission from 24.9% for infants born to placebo-treated mothers to 7.8% for infants born to mothers treated with zidovudine [see Clinical Studies (14.3)]. There were no differences in pregnancy-r

उत्पाद समीक्षा:

Zidovudine Tablets, USP  are available containing 300 mg of zidovudine, USP. The 300 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M 106 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6106-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ZIDOVUDINE- ZIDOVUDINE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIDOVUDINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZIDOVUDINE TABLETS.
ZIDOVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Zidovudine tablets, USP are a nucleoside analogue reverse
transcriptase inhibitor indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg (3)
CONTRAINDICATIONS
Hypersensitivity to zidovudine or any of the components (e.g.,
anaphylaxis, Stevens-Johnson syndrome). (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA HAVE BEEN
ASSOCIATED WITH THE USE OF
ZIDOVUDINE. (5.1)
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.3)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED
WITH THE USE OF NUCLEOSIDE ANALOGUES INCLUDING ZIDOVUDINE. SUSPEND
TREATMENT IF CLINICAL OR
LABORATORY FINDINGS SUGGESTIVE OF LACTIC ACIDOSIS OR PRONOUNCED
HEPATOTOXICITY OCCUR. (5.4)
Treatment of Human Immunodeficiency Virus (HIV-1) infection in
combination with other antiretroviral agents. (1.1)
Prevention of maternal-fetal HIV-1 transmission. (1.2)
Treatment of HIV-1 infection:
Adults: Recommended oral dosage is 300 mg twice a day with other
antiretroviral agents.
Pediatric patients (aged 4 weeks to less than 18 years): Dosage should
be calculated based on body weight not to
exceed adult dose. (2.2)
Prevention of maternal-fetal HIV-1 transmission: Specific dosage
instructions for mother and infant. (2.3)
Patients with severe anemia and/or neutropenia: Dosage interruption
may be necessary. (2.4)
Renal impairment: Recommended oral dosage in hemodialysis