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 mm3 (median in the treated group: 560 cells/mm3) 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 study 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 study, 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 [150/300 mg], containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white colored, oval, film coated tablets with “LZ” engraved on one side and breakline on other side.

They are available as follows:

Bottles of 60 NDC 64380-707-03

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

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 Warnings, 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 tablets 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 tablets and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of zidovudine, a component of lamivudine and zidovudine tablets [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 tablets are started [see Warnings and Precautions (5.7)].

Lipoatrophy

Advise patients that loss of subcutaneous fat may occur in patients receiving lamivudine and zidovudine tablets 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 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 lamivudine and 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)].

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

Manufactured by:

Strides Pharma Science Limited

Bengaluru — 562106, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 07/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-707-03

Lamivudine and Zidovudine

Tablets 150 mg/300 mg

Rx only

60 Tablets

Each tablet contains 150 mg of lamivudine and 300 mg of zidovudine.

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

See prescribing information for dosage information.

Do not use if printed safety seal under cap is broken or missing.

Manufactured by:

Strides Pharma Science Limited

Bengaluru — 562106, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

60s Bottles
(click image for full-size original)
LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-707
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code LZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-707-03 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079128 12/10/2016
Labeler — Strides Pharma Science Limited (650738743)
Registrant — Strides Pharma Science Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 918513263 MANUFACTURE (64380-707), ANALYSIS (64380-707)

Revised: 11/2019 Strides Pharma Science Limited

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