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Molecule

Lamivudine

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Available on requestHepatitis B and CHIV
Presentations
7
Brands
1
Manufacturers
1
Available from stock
0

Lamivudine is a hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. It is available as tablets and oral solution. MedsAcross supplies Lamivudine 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
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Analog, Nucleoside Reverse Transcriptase Inhibitors
ATC classification
J05AF05 Lamivudine · Direct acting antiviral, subgroup J05AF
US FDA first approval
17 November 1995
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, Oral solution
Identifiers
UNII 2T8Q726O95RxCUI 68244CAS 134678-17-4DrugBank DB00709Q422631

Clinical information

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

Uses

EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: • The dosage of this product is for HIV‑1 and not for HBV. EPIVIR is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection.

Source: US FDA prescribing information

Dosing overview

• Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 300 mg daily. • Patients with Renal Impairment: Doses of EPIVIR must be adjusted in accordance with renal function.

Source: US FDA prescribing information

Contraindications

EPIVIR is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. EPIVIR is contraindicated in patients with previous hypersensitivity reaction to lamivudine.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (exacerbations of hepatitis b and different formulations of epivir): Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. • Co-infected HIV‑1/HBV Patients: Emergence of lamivudine-resistant HBV variants associated with lamivudine‑containing antiretroviral regimens has been reported. • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. • Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis B. • Lactic acidosis and severe hepatomegaly with steatosis. • Pancreatitis. • Immune reconstitution syndrome. • The most common reported adverse reactions (incidence greater than or equal to 15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. • The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough.

Source: US FDA prescribing information

Interactions

Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations, when possible, avoid chronic coadministration. Drugs Inhibiting Organic Cation Transporters Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim). No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine. Sorbitol Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine.

Source: US FDA prescribing information

Storage

Store EPIVIR tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store in tightly closed bottles at 25°C (77°F).

Source: US FDA prescribing information

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

All presentations

7 presentations of Lamivudine, sorted by availability.

MedicineManufacturerRegisterAvailability
Lamivudine 150 mg tabletOralGeneric name—US FDAAvailable on request
Lamivudine 300 mg tabletOralGeneric name—US FDAAvailable on request
Lamivudine 100 mg tabletOralGeneric name—US FDAAvailable on request
Lamivudine 10 mg/mL oral solutionOralGeneric name—US FDAAvailable on request
Epivir 10 mg/mL oral solutionOralViiV HealthcareUS FDAAvailable on request
Epivir 150 mg tabletOralViiV HealthcareUS FDAAvailable on request
Epivir 300 mg tabletOralViiV 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 17 November 1995Drugs@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 in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Lamivudine available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Lamivudine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Lamivudine have?

The catalogue lists 1 brand names for Lamivudine, including Epivir.

Is Lamivudine approved by the US FDA?

Yes. The US FDA first approved Lamivudine on 17 November 1995, according to Drugs@FDA.

Is Lamivudine authorised in the European Union?

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

Does Lamivudine need cold chain shipping?

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

Which ATC class is Lamivudine in?

Lamivudine is classified under ATC code J05AF05 (Lamivudine).

References

  1. EPIVIR prescribing information (ViiV Healthcare). U.S. National Library of Medicine, DailyMed. Retrieved 15 August 2024
  2. Epivir: European public assessment report (EPAR). European Medicines Agency. Retrieved 20 August 2026
  3. Zeffix: European public assessment report (EPAR). European Medicines Agency. Retrieved 22 July 2026

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