Prescription Drug Information: Lamivudine and Zidovudine (Page 5 of 5)

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.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 02/2022

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg/300 mg (60 Tablet Bottle)

NDC 65862-036-60
Rx only
Lamivudine and
Zidovudine Tablets USP
150 mg/300 mg
AUROBINDO 60 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 150 mg/300 mg (60 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg/300 mg Carton (6 x 10 Unit-dose Tablets)

NDC 65862-036-10 Rx only
Lamivudine and
Zidovudine Tablets USP
150 mg/300 mg
AUROBINDO 6 X 10 Unit-Dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 150 mg/300 mg Carton (6 x 10) Unit-dose Tablets
(click image for full-size original)

LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-036
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 C;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-036-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-036-10 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-036-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077558 05/05/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-036), MANUFACTURE (65862-036)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-036), MANUFACTURE (65862-036)

Revised: 05/2022 Aurobindo Pharma Limited

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