Zidovudine (Page 9 of 9)

14.3 Prevention of Maternal-Fetal HIV-1 Transmission

The utility of zidovudine for the prevention of maternal-fetal HIV-1 transmission was demonstrated in a randomized, double-blind, placebo-controlled trial (ACTG 076) conducted in HIV-1-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells per mm 3 (median in the treated group: 560 cells per mm 3) who had little or no previous exposure to zidovudine. Oral zidovudine was initiated between 14 and 34 weeks of gestation (median 11 weeks of therapy) followed by IV administration of zidovudine during labor and delivery. Following birth, neonates received oral zidovudine syrup for 6 weeks. The trial showed a statistically significant difference in the incidence of HIV-1 infection in the neonates (based on viral culture from peripheral blood) between the group receiving zidovudine and the group receiving placebo. Of 363 neonates evaluated in the trial, the estimated risk of HIV-1 infection was 7.8% in the group receiving zidovudine and 24.9% in the placebo group, a relative reduction in transmission risk of 68.7%. Zidovudine was well tolerated by mothers and infants. There was no difference in pregnancy-related adverse events between the treatment groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

Zidovudine 300-mg tablets are supplied as white, biconvex, round, film-coated tablets containing 300 mg of zidovudine per tablet. Each tablet has one side debossed with “S2” and blank on the other side.

Bottles of 60 (NDC 0527-1905-06).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions

Inform patients that potentially life-threatening hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) can occur while receiving zidovudine tablets. Instruct patients to immediately contact their healthcare provider if they develop rash, as it may be a sign of a more serious reaction. Advise patients that it is very important that they remain under a healthcare provider’s care during treatment with zidovudine tablets [ see Contraindications (4) ].

Neutropenia and Anemia

Inform patients that the major toxicities of zidovudine tablets are neutropenia and/or anemia. The frequency and severity of these toxicities are greater in patients with more advanced disease and in those who initiate therapy later in the course of their infection. Advise patients that if toxicity develops, they may require transfusions or drug discontinuation. Advise patients of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced symptomatic HIV-1 disease [see Boxed Warning, Warnings and Precautions (5.1)] .

Myopathy

Inform patients that myopathy and myositis with pathological changes, similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine tablets [see Boxed Warning, Warnings and Precautions (5.3)] .

Lactic Acidosis/Hepatomegaly with Steatosis

Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking zidovudine tablets if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Boxed Warning, Warnings and Precautions (5.4)] .

HIV-1/HCV Co-infection

Inform patients with HIV-1/HCV co-infection that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see Warnings and Precautions (5.5)] .

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when zidovudine tablets are started [see Warnings and Precautions (5.6)].

Lipoatrophy

Advise patients that loss of subcutaneous fat may occur in patients receiving zidovudine tablets and that they will be regularly assessed during therapy [see Warnings and Precautions (5.7)] .

Common Adverse Reactions

Inform patients that the most commonly reported adverse reactions in adult patients being treated with zidovudine tablets were headache, malaise, nausea, anorexia, and vomiting. The most commonly reported adverse reactions in pediatric patients receiving zidovudine tablets were fever, cough, and digestive disorders. Patients also should be encouraged to contact their physician if they experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis, or any other unexpected adverse events while being treated with zidovudine tablets [see Adverse Reactions (6)] .

Drug Interactions

Advise patients that other medications may interact with zidovudine tablets and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of zidovudine tablets [see Drug Interactions (7)] .

Pregnancy

Inform pregnant women considering the use of zidovudine tablets during pregnancy for prevention of HIV-1 transmission to their infants that transmission may still occur in some cases despite therapy.

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine tablets during pregnancy [see Use in Specific Populations (8.1)] .

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)] .

Missed Dose

Instruct patients that if they miss a dose of zidovudine tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [ see Dosage and Administration (2) ].

EPIVIR is registered trademarks of the ViiV Healthcare group of companies.

Manufactured by:

LogoSunshine Lake Pharma Co., Ltd.

Guangdong Province 523808

P.R. China

Manufactured for:

Lannett Company, Inc.

Philadelphia, PA 19136

Revised: 11/2019

1426

PRINCIPAL DISPLAY PANEL – 300 mg

NDC 0527-1905-06

ZIDOVUDINE
TABLETS, USP
300 mg
Rx only
60 Tablets

Each tablet contains 300 mg of zidovudine.

Usual Dosage: See package insert for Dosage and Administration.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preserve in tight, light-resistant containers.

Manufactured for:
Lannett Company, Inc.
Philadelphia, PA19136

by:
Sunshine Lake Pharma Co., Ltd.
Guangdong Province, China

Rev. 11/19 1426

Zidovudine Tablets, USP 300 mg Bottle Label
(click image for full-size original)
ZIDOVUDINE zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1905
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL
TALC
LECITHIN, SOYBEAN
Product Characteristics
Color white (white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code S;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1905-06 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202058 03/25/2014
Labeler — Lannett Company, Inc. (002277481)

Revised: 11/2019 Lannett Company, Inc.

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