Schedule H

Oral

• Tablet: 150 mg, 300 mg

• Oral solution: 10 mg/mL (240 mL bottle)

• Fixed-dose combinations (FDCs): Available with zidovudine, abacavir, tenofovir (multiple strengths)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. HIV-1 Infection (as part of combination antiretroviral therapy)

Adults and Adolescents ≥16 years:

Component Details

Starting dose 300 mg once daily OR 150 mg twice daily

Titration Not applicable

Usual maintenance dose 300 mg once daily OR 150 mg twice daily

Maximum dose 300 mg/day

Clinical Notes:

• Must always be used in combination with at least one other NRTI plus one agent from another class (INSTI, NNRTI, or PI)

• Once-daily dosing preferred for adherence; twice-daily may be used in fixed-dose combinations

• Monitor HIV viral load for treatment response

1. Chronic Hepatitis B Infection (monoinfected, non-cirrhotic or compensated cirrhosis)

Adults:

Component Details

Starting dose 100 mg once daily

Titration Not applicable

Usual maintenance dose 100 mg once daily

Maximum dose 100 mg/day

Clinical Notes:

• Minimum treatment duration: 12 months; continue based on virological and hepatic response

• Not first-line therapy due to low genetic barrier to resistance

• Tenofovir preferred for long-term HBV treatment

• Monitor HBV DNA every 3–6 months during therapy

• Risk of severe hepatitis flare upon discontinuation

Secondary Indications – Adults (Off-label)

Indication Dose Duration Notes

HIV Post-Exposure Prophylaxis (PEP) — OFF-LABEL as monotherapy 300 mg once daily OR 150 mg twice daily 28 days Must be used only as part of triple-drug regimen (e.g., tenofovir + lamivudine + dolutegravir); NACO protocol-based; Specialist supervision recommended

Evidence basis: NACO national PEP guidelines; WHO PEP recommendations (supportive)

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: HIV-1 Infection

Weight-based dosing (as per IAP/NACO guidelines):

Weight Dose

<14 kg 4 mg/kg twice daily (use oral solution)

14–<20 kg 75 mg twice daily

20–<25 kg 75 mg morning + 150 mg evening

≥25 kg 150 mg twice daily OR 300 mg once daily

Component Details

Starting dose Weight-based as per table above

Titration Not applicable

Usual maintenance dose As per weight band

Maximum dose 300 mg/day

Minimum age: 2 weeks corrected gestational age; used routinely in PMTCT and paediatric ART programmes

Safety Monitoring:

• Complete blood count

• Liver function tests

• HIV viral load suppression

• Growth parameters (weight, height)

• Clinical signs of pancreatitis

Secondary Indications – Paediatrics (Off-label)

Indication Dose Duration Notes

Chronic Hepatitis B — OFF-LABEL 3 mg/kg once daily (maximum 100 mg/day) Minimum 12 months Specialist only; use only when tenofovir not feasible; compensated disease only

Evidence basis: Indian specialist practice; WHO supportive guidance

Age restriction: Not recommended below 2 weeks of age except under specialist supervision

Required — lamivudine is primarily renally excreted

CrCl (mL/min) Dose Adjustment

≥50 300 mg once daily (no adjustment)

30–49 150 mg once daily

15–29 150 mg loading dose, then 100 mg once daily

5–14 150 mg loading dose, then 50 mg once daily

<5 or on haemodialysis 50 mg loading dose, then 25 mg once daily

Haemodialysis: Administer dose after dialysis session on dialysis days

Note: Use oral solution for doses not achievable with tablets

• Mild to moderate impairment: No dose adjustment required

• Severe impairment: Use with caution; not directly hepatotoxic but HBV co-infection may complicate clinical picture

• Monitoring: ALT, AST, bilirubin, and HBV DNA (if applicable) should be monitored regularly

• Known hypersensitivity to lamivudine or any excipient

• Prior hypersensitivity reaction to any fixed-dose combination containing lamivudine

• History of pancreatitis or risk factors for pancreatitis (especially in children)

• HBV co-infection: risk of severe acute hepatitis flare upon discontinuation

• Documented lamivudine resistance in HBV infection

• Lactic acidosis and severe hepatomegaly with steatosis (rare but potentially fatal; NRTIs as a class)

• Avoid prolonged monotherapy — increases risk of resistance development

• Renal impairment — requires dose adjustment

• Obesity and prolonged nucleoside exposure — increased risk of mitochondrial toxicity

Aspect Details

Overall safety Compatible; safe across all trimesters

India guidelines Included in NACO and WHO PMTCT regimens

Evidence No increased risk of birth defects in pregnancy registries

Preferred regimen Tenofovir + lamivudine + dolutegravir (NACO 2021 guideline)

Monitoring Liver function tests, HIV viral load

Aspect Details

Compatibility Compatible with breastfeeding (NACO, WHO)

Drug levels in milk Low

Infant monitoring Observe for hypersensitivity; regular growth monitoring

Counselling Emphasize maternal ART adherence and continuation

• Start at standard adult dose after assessing renal function

• Renal function assessment mandatory before initiation (age-related decline common)

• Monitor closely for signs of renal deterioration, especially in patients >65 years

• Increased susceptibility to lactic acidosis if hepatic or renal reserve is limited

• Slower titration not typically required if renal function is adequate

Interacting Drug Effect/Mechanism Recommendation

Emtricitabine Overlapping mechanism (both cytidine analogues); no added efficacy; increased resistance risk Avoid combination

Sorbitol-containing products Reduces lamivudine absorption (especially with oral solution) Avoid co-administration where possible

Interacting Drug Effect/Mechanism Recommendation

Co-trimoxazole Increases lamivudine plasma concentration (inhibits renal tubular secretion) Monitor closely, especially in renal impairment

Tenofovir Synergistic antiviral effect Safe combination; standard in NACO regimens

Interferon (alfa) Additive hepatotoxicity when treating HBV/HIV co-infection Monitor hepatic function closely

Nephrotoxic drugs (aminoglycosides, amphotericin B) May compound renal toxicity Monitor renal function closely

• Headache

• Nausea

• Vomiting

• Fatigue and malaise

• Diarrhoea

• Cough and nasal symptoms

• Transient elevation of liver enzymes

• Abdominal discomfort

• Lactic acidosis with hepatic steatosis — rare but potentially fatal; requires immediate discontinuation

• Pancreatitis — especially in paediatric population; discontinue if suspected

• Severe hepatomegaly

• Hypersensitivity reactions

• Immune reconstitution inflammatory syndrome (IRIS) — in HIV patients after ART initiation

• Severe acute exacerbation of hepatitis B — upon discontinuation in HBV-infected patients

→ All serious adverse effects require prompt discontinuation and specialist referral

Phase Parameters

Baseline CBC, renal function (serum creatinine, eGFR), hepatic panel (ALT, AST, bilirubin), HIV viral load, HBV serology (if status unknown)

During treatment Renal function every 3 months (more frequently if impaired); liver enzymes every 3–6 months; HIV or HBV viral load as per indication

Long-term Signs of lactic acidosis; lipodystrophy; pancreatitis symptoms (especially in children)

• Lamivir® (Cipla)

• Heptavir® (Cipla) — for HBV

• Lamivudine IP (Hetero, Emcure, Natco, Aurobindo)

• FDCs:

• Duovir® (lamivudine + zidovudine)

• Tenvir-L® (lamivudine + tenofovir)

• Abamune-L® (lamivudine + abacavir)

• Telura® (lamivudine + tenofovir + efavirenz)

• NLEM status: Yes (monotherapy and FDCs included)

• Price controlled: Under NPPA ceiling

• Government supply: Available free through NACO ART centres

• Lamivudine is well tolerated and forms the backbone of many first-line ART regimens in India

• Low genetic barrier to resistance — never use as monotherapy for HIV; HBV monotherapy also carries resistance risk

• In HBV/HIV co-infected patients, use HIV-dose (300 mg) rather than HBV-dose (100 mg)

• Essential to continue lamivudine in HBV-positive patients even when used primarily for HIV — abrupt discontinuation may trigger severe hepatitis flare

• Preferred NRTI for pregnant women and neonates in PMTCT programmes

• Oral solution useful for paediatric dosing and fine dose adjustments in renal impairment

• Always check HBV status before initiating lamivudine for HIV — and before stopping it

Lamivudine; HIV; Hepatitis B; NRTI; antiretroviral; pregnancy-safe; renal-dose-adjust; paediatric-HIV; ART India; NPPA-controlled; NLEM

RxIndia v1.1 — 18 Jan 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• NACO National Technical Guidelines on Antiretroviral Therapy (2021)

• API Textbook of Medicine (11th Edition) — HIV and Hepatitis B chapters

• IAP Guidelines on Paediatric HIV Management

• WHO Consolidated Guidelines on HIV (supportive safety information)

• AIIMS HIV/HBV Treatment Protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)

• National List of Essential Medicines (NLEM) 2022, India