Lamivudine and Zidovudine (Page 6 of 6)

14.2 Prevention of Maternal-Fetal HIV-1 Transmission

The utility of zidovudine alone for the prevention of maternal-fetal HIV-1 transmission was demonstrated in a randomized, double-blind, placebo-controlled trial 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

Lamivudine and Zidovudine Tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white, modified capsule shaped, biconvex, film-coated tablets with deep breakline in between ‘J’ and ‘58’ on one side and deep breakline on the other side. They are available as follows:
Unit dose packages of 30 (5 x 6) NDC 68084-416-25

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

17 PATIENT COUNSELING INFORMATION

Neutropenia and Anemia
Inform patients that the important toxicities associated with zidovudine are neutropenia and/or anemia. Inform them of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced 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 [see Warnings and Precautions (5.2)].

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 lamivudine and zidovudine if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.3)].

Patients with Hepatitis B or C Co-infection
Advise patients co-infected with HIV-1 and HBV that worsening of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Advise patients to discuss any changes in regimen with their healthcare provider [see Warnings and Precautions (5.4)].

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)].

Drug Interactions
Advise patients that other medications may interact with lamivudine and zidovudine and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of zidovudine, a component of lamivudine and zidovudine [see Drug Interactions (7.1)].

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 lamivudine and zidovudine is started [see Warnings and Precautions (5.7)].

Lipoatrophy
Advise patients that loss of subcutaneous fat may occur in patients receiving lamivudine and zidovudine and that they will be regularly assessed during therapy [see Warnings and Precautions (5.8)].

Pregnancy Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine 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 lamivudine and zidovudine, 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)].

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Aurobindo Pharma USA, Inc. as follows:
(150 mg/300 mg / 30 UD) NDC 68084-416-25 packaged from NDC 65862-597

Distributed by:
American Health Packaging Columbus, OH 43217

8241625/0321F

Package/Label Display Panel – Carton – 150 mg/300 mg

150 mg/300 mg Lamivudine and Zidovudine Tablets Carton
(click image for full-size original)

NDC 68084- 416 -25

Lamivudine and
Zidovudine
Tablets USP

150 mg/300 mg

30 Tablets (5 x 6)                 Rx Only

Each Film-Coated Tablet Contains:
Lamivudine USP ……………………………………… 150 mg
Zidovudine USP ………………………………………. 300 mg

Usual Dosage: See package insert for full
prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see
USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 65862-597, Aurobindo Pharma USA, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

041625 0241625/0319OS

Package/Label Display Panel – Blister – 150 mg/300 mg

150 mg/300 mg Lamivudine and Zidovudine Tablet Blister
(click image for full-size original)

Lamivudine and
Zidovudine Tablet USP

150 mg/300 mg

LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-416(NDC:65862-597)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score 2 pieces
Shape CAPSULE (Modified Capsule Shaped, Biconvex) Size 17mm
Flavor Imprint Code J;58
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-416-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-416-95)
1 NDC:68084-416-95 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-416-25)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202418 02/15/2014
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-416)

Revised: 08/2021 American Health Packaging

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