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Fixed-dose combination

Lamivudine and Zidovudine

Also known as lamivudine, zidovudine
Available on requestHIV
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Lamivudine and Zidovudine is a fixed-dose combination of a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor and a hepatitis B virus nucleoside analog reverse transcriptase inhibitor. It is available as tablets for oral use. MedsAcross supplies Lamivudine and Zidovudine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Analog, Nucleoside Reverse Transcriptase Inhibitors
ATC classification
J05AR01 Lamivudine and Zidovudine · Efavirenz/lamivudine/tenofovir
US FDA first approval
26 September 1997
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Fixed-dose combination of
Lamivudine, Zidovudine
Identifiers
RxCUI 214671CAS 165456-81-5Q6482030

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

COMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection.

Source: US FDA prescribing information

Dosing overview

• Adults and Adolescents weighing greater than or equal to 30 kg: 1 tablet orally twice daily. • Pediatrics weighing greater than or equal to 30 kg: 1 tablet orally twice daily. • Because COMBIVIR is a fixed‑dose tablet and cannot be dose adjusted, COMBIVIR is not recommended in patients requiring dosage adjustment or with hepatic impairment or experiencing dose‑limiting adverse reactions.

Source: US FDA prescribing information

Contraindications

COMBIVIR is contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning: Zidovudine, a component of COMBIVIR (lamivudine and zidovudine) tablets, has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV ‑ 1) disease. Prolonged use of zidovudine has been associated with symptomatic myopathy. • Hepatic decompensation, some fatal, has occurred in HIV‑1/HCV co‑infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Discontinue COMBIVIR as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. • Exacerbation of anemia has been reported in HIV‑1/HCV co‑infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia. • Symptomatic myopathy. • Lactic acidosis and severe hepatomegaly with steatosis. • Exacerbations of hepatitis B. • Hepatic decompensation in patients co-infected with HIV‑1 and hepatitis C. • Exacerbation of anemia in HIV‑1/HCV co-infected patients receiving ribavirin and zidovudine. • Pancreatitis. • Immune reconstitution syndrome. • Lipoatrophy. • 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.

Source: US FDA prescribing information

Interactions

• Agents antagonistic with zidovudine: Concomitant use should be avoided. • Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations, when possible, avoid chronic coadministration.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Lamivudine and Zidovudine, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Lamivudine and Zidovudine 150 mg/300 mg tabletOralGeneric nameLamivudine and Zidovudine—US FDAAvailable on request
Combivir 150 mg/300 mg tabletOralLamivudine and ZidovudineViiV HealthcareUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 26 September 1997Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Lamivudine and Zidovudine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Lamivudine and Zidovudine available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Lamivudine and Zidovudine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Lamivudine and Zidovudine have?

The catalogue lists 1 brand names for Lamivudine and Zidovudine, including Combivir.

Is Lamivudine and Zidovudine approved by the US FDA?

Yes. The US FDA first approved Lamivudine and Zidovudine on 26 September 1997, according to Drugs@FDA.

Is Lamivudine and Zidovudine authorised in the European Union?

Yes. Lamivudine and Zidovudine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Lamivudine and Zidovudine need cold chain shipping?

No listed presentation of Lamivudine and Zidovudine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Lamivudine and Zidovudine in?

Lamivudine and Zidovudine is classified under ATC code J05AR01 (Lamivudine and Zidovudine).

References

  1. COMBIVIR prescribing information (ViiV Healthcare). U.S. National Library of Medicine, DailyMed. Retrieved 22 August 2023
  2. Combivir: European public assessment report (EPAR). European Medicines Agency. Retrieved 29 August 2022

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