ZIDOVUDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla Ltd.

INN (International Name):

ZIDOVUDINE

Composition:

ZIDOVUDINE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zidovudine, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Zidovudine is 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 3 components: - antepartum therapy of HIV-1 infected mothers - intrapartum therapy of HIV-1 infected mothers - post-partum therapy of HIV-1 exposed neonate Points to consider prior to initiating Zidovudine in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: - In most cases, Zidovudine for prevention of maternal-fetal HIV-1 transmission should be  given in combination with other antiretroviral drugs. - Prevention of HIV-1 transmission in women who have received Zidovudine for a prolonged period before pregnancy has not been evaluated. - Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of ges

Product summary:

Zidovudine tablets USP, 300 mg are white, circular, biconvex , film coated tablets with '300' debossed on one side and 'ZVR' on other side Zidovudine tablets USP,300 mg  are available as follows : Bottle of 60 tablets (NDC 53104- 0101-2) Bottle of 1000 tablets (NDC 53104 - 0101-6) Unit dose boxes of 100 tablets (NDC 53104 – 0101 -9) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZIDOVUDINE- ZIDOVUDINE TABLET, FILM COATED
CIPLA LTD.
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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 AND
SEVERE
HEPATOMEGALY WITH STEATOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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)
INDICATIONS AND USAGE
Zidovudine is a nucleoside analogue reverse transcriptase inhibitor
indicated for:
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)
DOSAGE AND ADMINISTRATION
● Treatment of HIV-1 infection:
Adults: Recommended oral dosage is 300 mg twice a day with other
antiretroviral agents. (2.1)
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 or
peritoneal dialysis or in patients with creatinine
clearance (CrCl) less than 15 mL per minute is 100 mg every 6 to 8
hours. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg (3)
CONTRAINDICATIONS
Hypersensitivity to zidovudine or any of the