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Lamivudine: Indications, Dosing, Side Effects and Interactions
Lamivudine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Lamivudine: Indications, Dosing, Side Effects and Interactions
Lamivudine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**HIV infection in combination with other antiretroviral drugs**
- **Adult** (By Mouth): 150 mg every 12 hours, alternatively 300 mg once daily.
**Chronic hepatitis B infection either with compensated liver disease (with evidence of viral replication and histology of active liver inflammation or fibrosis) when first-line treatments cannot be used, or (in combination with another antiviral drug without cross-resistance to lamivudine) with decompensated liver disease**
- **Adult** (By Mouth): 100 mg once daily, patients receiving lamivudine for concomitant HIV infection should continue to receive lamivudine in a dose appropriate for HIV infection.
**HIV infection in combination with other antiretroviral drugs for Epivir oral solution**
- **Child 1-2 months** (By mouth): 4 mg/kg twice daily.
- **Child 3 months-11 years (body-weight up to 14 kg)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg).
- **Child 3 months-11 years (body-weight 14-20 kg)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg), alternatively 75 mg twice daily, alternatively 150 mg once daily.
- **Child 3 months-11 years (body-weight 21-29 kg)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg), alternatively 75 mg daily, dose to be taken in the morning and 150 mg daily, dose to be taken in the evening, alternatively 225 mg once daily.
- **Child 3 months-11 years (body-weight 30 kg and above)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg), alternatively 150 mg twice daily, alternatively 300 mg once daily.
- **Child 12-17 years** (By mouth): 150 mg twice daily, alternatively 300 mg once daily.
**HIV infection in combination with other antiretroviral drugs for Epivir tablets**
- **Child 1-2 months** (By mouth): 4 mg/kg twice daily.
- **Child 3 months-11 years (body-weight up to 14 kg)** (By mouth): 4 mg/kg twice daily, alternatively 8 mg/kg once daily.
- **Child 3 months-11 years (body-weight 14-20 kg)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg), alternatively 75 mg twice daily, alternatively 150 mg once daily.
- **Child 3 months-11 years (body-weight 21-29 kg)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg), alternatively 75 mg daily, dose to be taken in the morning and 150 mg daily, dose to be taken in the evening, alternatively 225 mg once daily.
- **Child 3 months-11 years (body-weight 30 kg and above)** (By mouth): 4 mg/kg twice daily (max. per dose 150 mg), alternatively 8 mg/kg once daily (max. per dose 300 mg), alternatively 150 mg twice daily, alternatively 300 mg once daily.
- **Child 12-17 years** (By mouth): 150 mg twice daily, alternatively 300 mg once daily.
**Chronic hepatitis B infection either with compensated liver disease (with evidence of viral replication and histology of active liver inflammation or fibrosis) when first-line treatments cannot be used, or (in combination with another antiviral drug without cross-resistance to lamivudine) with decompensated liver disease for Zeffix**
- **Child 2-11 years** (By mouth): 3 mg/kg once daily (max. per dose 100 mg), children receiving lamivudine for concomitant HIV infection should continue to receive lamivudine in a dose appropriate for HIV infection.
- **Child 12-17 years** (By mouth): 100 mg once daily, patients receiving lamivudine for concomitant HIV infection should continue to receive lamivudine in a dose appropriate for HIV infection.
Cautions
Recurrent hepatitis in patients with chronic hepatitis B may occur on discontinuation of lamivudine
Side effects
For all nucleoside reverse transcriptase inhibitors Common or very common Abdominal pain; anaemia (may require transfusion); asthenia; diarrhoea; dizziness; fever; flatulence; headache; insomnia; nausea; neutropenia; skin reactions; vomiting Uncommon Angioedema; pancreatitis Rare or very rare Lactic acidosis Frequency not known Immune reconstitution inflammatory syndrome; osteonecrosis; weight increased Side-effects, further information Osteonecrosis has been reported in patients with advanced HIV disease or following long-term exposure to combination antiretroviral therapy. Side-effects For lamivudine Common or very common Alopecia; arthralgia; cough; gastrointestinal discomfort; hepatic disorders; malaise; muscle complaints; myopathy; nasal disorder Uncommon Thrombocytopenia Rare or very rare Paraesthesia; peripheral neuropathy; pure red cell aplasia Frequency not known Respiratory tract infection; throat complaints
Interactions
**Severe interactions:**
- Substances shown to be predominately excreted either via the active organic anionic pathway, or by glomerular filtration are unlikely to yield clinically significant interactions with lamivudine.
- A modest increase in C max (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
- There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e.g.
**Other interactions (15):**
- Lamivudine is predominantly eliminated by active organic cationic secretion.
- The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the...
- Other medicinal products (e.g.
- Administration of trimethoprim/sulphamethoxazole 160 mg/800 mg increased lamivudine exposure by about 40%.
- Lamivudine had no effect on the pharmacokinetics of trimethoprim or sulphamethoxazole.
- However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary.
Pregnancy
For all nucleoside reverse transcriptase inhibitors Monitoring in pregnancy Mitochondrial dysfunction has been reported in infants exposed to nucleoside reverse transcriptase inhibitors in utero; the main effects include haematological, metabolic, and neurological disorders; all infants whose mothers received nucleoside reverse transcriptase inhibitors during pregnancy should be monitored for relevant signs or symptoms.
Breast feeding
Can be used with caution in women infected with chronic hepatitis B alone, providing that adequate measures are taken to prevent hepatitis B infection in infants.
Hepatic impairment
For all nucleoside reverse transcriptase inhibitors In general, manufacturers advise caution in patients with chronic hepatitis B or C (increased risk of hepatic side-effects).
Renal impairment
Dose adjustments Reduce dose if creatinine clearance less than 50 mL/minute (consult product literature). M See Prescribing in renal impairment .
Medicinal forms
Tablet,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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