ZIDOVUDINE - zidovudine tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Citron Pharma LLC

DCI (Denominação Comum Internacional):

ZIDOVUDINE

Composição:

ZIDOVUDINE 300 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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, USP 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 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 tablets, USP in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: - In most cases, zidovudine tablets, USP 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 tablets, USP for a prolonged period before pregnancy has not been evaluated. - Because the fetus is most susceptible to the pote

Resumo do produto:

Zidovudine Tablets USP, 300 mg are white colored, biconvex, round, film-coated tablets debossed with ‘D’ on one side and ‘11’ on other side.                      Bottle of 60                               NDC 57237-241-60                       Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ZIDOVUDINE - ZIDOVUDINE TABLET, FILM COATED
CITRON PHARMA LLC
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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._
_ _
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 tablets, USP are 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 components (e.g.,
anaphylaxi