RETROVIR- zidovudine capsule RETROVIR- zidovudine solution RETROVIR- zidovudine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ViiV Healthcare Company

INN (International Name):

ZIDOVUDINE

Composition:

ZIDOVUDINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RETROVIR, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. RETROVIR 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: Points to consider prior to initiating RETROVIR in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: RETROVIR is 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. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RETROVIR during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the o

Product summary:

RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex. Bottles of 100 (NDC 49702-211-20). Store at 15° to 25°C (59° to 77°F) and protect from moisture. RETROVIR oral solution is supplied as a colorless to pale yellow, strawberry-flavored solution containing 10 mg zidovudine in each mL. Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap. Store at 15° to 25°C (59° to 77°F). RETROVIR injection, 10 mg zidovudine in each mL. 20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26). Store vials at 15° to 25°C (59° to 77°F) and protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

RETROVIR- ZIDOVUDINE CAPSULE
RETROVIR- ZIDOVUDINE SOLUTION
RETROVIR- ZIDOVUDINE INJECTION, SOLUTION
VIIV HEALTHCARE COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RETROVIR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RETROVIR.
RETROVIR (ZIDOVUDINE) CAPSULES, FOR ORAL USE
RETROVIR (ZIDOVUDINE) ORAL SOLUTION
RETROVIR (ZIDOVUDINE) INJECTION, FOR INTRAVENOUS 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._
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INDICATIONS AND USAGE
RETROVIR is a nucleoside analogue reverse transcriptase inhibitor
indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Hypersensitivity to zidovudine or any of the components (e.g.,
anaphylaxis, Stevens-Johnson syndrome).
(4)
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
RETROVIR.
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. For patients
who are unable to take the oral formulations, the recommended
intravenous dose is 1 mg per kg
infused over 1 hour every 4 hours. (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-feta