Fixed-dose combination
Abacavir and Lamivudine 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 Abacavir and 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
From the regulator-approved product information. Each section names its source.
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, are combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Source: US FDA prescribing information
Abacavir and lamivudine is an antiretroviral agent with activity against HIV-1.
Source: US FDA prescribing information
Before initiating abacavir and lamivudine tablets, screen for the HLA-B*5701 allele because abacavir and lamivudine tablets contain abacavir. Adults: One tablet orally once daily. Pediatric patients weighing at least 25 kg: One tablet daily. Because abacavir and lamivudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir and lamivudine tablets are not recommended in patients with creatinine clearance less than 30 mL per minute or patients with hepatic impairment.
Source: US FDA prescribing information
Abacavir and lamivudine tablets are contraindicated in patients: who have the HLA-B*5701 allele. with prior hypersensitivity reaction to abacavir or lamivudine. with moderate or severe hepatic impairment. Presence of HLA-B*5701 allele. Prior hypersensitivity reaction to abacavir or lamivudine. Moderate or severe hepatic impairment.
Source: US FDA prescribing information
Boxed warning (hypersensitivity reactions and exacerbations of hepatitis b): Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of abacavir and lamivudine. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
Source: US FDA prescribing information
The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions. Exacerbations of hepatitis B. Lactic acidosis and severe hepatomegaly with steatosis. Immune reconstitution syndrome. Myocardial infarction. The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea.
Source: US FDA prescribing information
Methadone: An increased methadone dose may be required in a small number of patients. Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations, when possible, avoid chronic coadministration. Riociguat: The riociguat dose may need to be reduced.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Abacavir and Lamivudine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Abacavir and Lamivudine 600 mg/300 mg tabletOralGeneric name | Abacavir and Lamivudine | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Abacavir and Lamivudine and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Abacavir and Lamivudine on 2 August 2004, according to Drugs@FDA.
Yes. Abacavir and Lamivudine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Abacavir and Lamivudine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Abacavir and Lamivudine is classified under ATC code J05AR02 (Abacavir and Lamivudine).
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