Drugplain

LAMIVUDINE AND ZIDOVUDINE 150 mg/1

lamivudine and zidovudine · TABLET, FILM COATED · XLCare Pharmaceuticals, Inc

No Recall History
Plain English

LAMIVUDINE AND ZIDOVUDINE is a tablet, film coated containing lamivudine and zidovudine at 150 mg/1, taken oral. Manufactured by XLCare Pharmaceuticals, Inc.

Key Facts

Brand Name
LAMIVUDINE AND ZIDOVUDINE
Generic Name
lamivudine and zidovudine
NDC Code (Product)
72865-144
Manufacturer
XLCare Pharmaceuticals, Inc
Strength
150 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA203259
Drug Class
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Marketing Start
04/17/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

foetal exposure during pregnancy189 reports
maternal exposure during pregnancy132 reports
exposure during pregnancy98 reports
pathogen resistance89 reports
virologic failure79 reports
viral mutation identified75 reports
abortion spontaneous61 reports
lipodystrophy acquired49 reports
treatment noncompliance49 reports
premature baby48 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & USAGE Lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)

Dosage & Administration

2 DOSAGE & ADMINISTRATION • Adults and Adolescents weighing greater than or equal to 30 kg: 1 tablet orally twice daily. (2.1) • Pediatrics weighing greater than or equal to 30 kg: 1 tablet orally twice daily. (2.2) • Because lamivudine and zidovudine tablet is a fixed-dose tablet and cannot be dose adjusted, lamivudine and zidovudine tablet is not recommended in patients requiring dosage adjustment or with hepatic impairment or experiencing dose-limiting adverse reactions. (2.3, 4) 2.1 Recommended Dosage for Adults and Adolescents The recommended dosage of lamivudine and zidovudine tablet in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) taken orally twice daily. 2.2 Recommended Dosage for Pediatric Patients The recommended dosage of scored lamivudine and zidovudine tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily. Before prescribing lamivudine and zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably…

Contraindications

4 CONTRAINDICATIONS Lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. Lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. (4)

Drug Interactions

7 DRUG INTERACTIONS • Agents antagonistic with zidovudine: Concomitant use should be avoided. (7.1) • Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. (7.1) • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. (7.2) • Agents antagonistic with zidovudine: Concomitant use should be avoided. (7.1) • Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. (7.1) • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. (7.2) 7.1 Zidovudine Agents Antagonistic with Zidovudine Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro : • Stavudine • Doxorubicine • Nucleoside analogues, e.g., ribavirin Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration with the following drugs may increase the hematologic toxicity of zidovudine: • Ganciclovir • Interferon alfa • Ribavirin • Other bone marrow suppressive or cytoto…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions (5.1)]. • Symptomatic myopathy [see Boxed Warning, Warnings and Precautions (5.2)]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.3)]. • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions (5.4)]. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.5)]. • Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see Warnings and Precautions (5.5)]. • Pancreatitis [see Warnings and Precautions (5.6)]. • Immune reconstitution syndrome [see Warnings and Precautions (5.7)]. • Lipoatrophy [see Warnings and Precautions (5.8)]. • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in clinical trials of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hetero La…

Frequently Asked Questions

What is LAMIVUDINE AND ZIDOVUDINE used for?

LAMIVUDINE AND ZIDOVUDINE contains lamivudine and zidovudine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is LAMIVUDINE AND ZIDOVUDINE a controlled substance?

LAMIVUDINE AND ZIDOVUDINE is not classified as a controlled substance by the DEA.

What is the generic name for LAMIVUDINE AND ZIDOVUDINE?

The generic name for LAMIVUDINE AND ZIDOVUDINE is lamivudine and zidovudine. There are 9 other brand versions of lamivudine and zidovudine.

What is the NDC code for LAMIVUDINE AND ZIDOVUDINE 150 mg/1?

The NDC (National Drug Code) for LAMIVUDINE AND ZIDOVUDINE 150 mg/1 is 72865-144, listed by XLCare Pharmaceuticals, Inc.

Product NDC

72865-144

Package NDC

72865-144-60

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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