Contraindicated in:
- Hypersensitivity
- Concurrent use of antiretroviral combination products containing lamivudine or emtricitabine.
Use Cautiously in:
- Renal impairment (↑ dosing interval/↓ dose if CCr <50 mL/min)
- Women and obesity (↑ risk of lactic acidosis and severe hepatomegaly with steatosis)
- Patients with HIV who are coinfected with HBV (hepatitis may recur after discontinuation of lamivudine)
- OB: Considered a preferred nucleoside reverse transcriptase inhibitor (NRTI) for pregnant patients with HIV infection who are antiretroviral-naive, who have had antiretroviral therapy in the past but are restarting, or who require a new antiretroviral regimen; use has also been studied in pregnant women with HBV
- Lactation: Breastfeeding should be supported in people with HIV who are taking antiretroviral therapy, as prescribed, and are maintaining an undetectable amount of virus in the body
- Pedi: Safety and effectiveness not established in children <3 mo (HIV) or <2 yr (HBV)
- Geri: ↓dose may be necessary in older adults due to age-related ↓ in renal function.
Exercise Extreme Caution in:
- Pedi: Pediatric patients with a history of or significant risk factors for pancreatitis (use only if no alternative).
Derm: alopecia, erythema multiforme, rash, urticaria.
Endo: hyperglycemia.
F and E: lactic acidosis.
GI: anorexia, diarrhea, nausea, vomiting, ↑ liver enzymes, abdominal discomfort, dyspepsia, HEPATOMEGALY WITH STEATOSIS, PANCREATITIS (↑ IN PEDIATRIC PATIENTS).
Hemat: anemia, neutropenia, pure red cell aplasia.
MS: musculoskeletal pain, arthralgia, muscle weakness, myalgia, rhabdomyolysis.
Neuro: fatigue, headache, insomnia, malaise, neuropathy, depression, dizziness, SEIZURES.
Resp: cough.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), immune reconstitution syndrome.
Therapeutic Classification: antiretrovirals, antivirals
Pharmacologic Classification: nucleoside reverse transcriptase inhibitors
Absorption: Well absorbed after oral administration (86% in adults, 66% in infants and children).
Distribution: Distributes into the extravascular space. Some penetration into CSF; remainder of distribution unknown.
Metabolism/Excretion: Mostly excreted unchanged in urine; <5% metabolized by the liver.
Half-life: 5–7 hr.
(plasma concentrations)
†On an empty stomach; peak levels occur at 3.2 hr if lamivudine is taken with food. Food does not affect total amount of drug absorbed.
3 mo): Oral solution: 5 mg/kg twice daily or 10 mg/kg once daily (max dose = 300 mg/day); Tablets: 14–19 kg: 75 mg twice daily or 150 mg once daily; 20–24 kg: 75 mg in AM, 150 mg in PM (or 225 mg once daily);