Therapeutic Classification: antiretrovirals, antivirals
Pharmacologic Classification: nucleoside reverse transcriptase inhibitors
REMS
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.
Half-Life: 57 hr.
(plasma concentrations)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
PO | unknown | 0.9 hr‡ | 12 hr |
‡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.
Contraindicated in:
Use Cautiously in:
Chronic hepatitis B virus (HBV) infection (may exacerbate following discontinuation)
;Exercise Extreme Caution in:
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)↑ 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
Drug-drug:
HIV-1 Infection
Renal Impairment
Chronic Hepatitis B
Renal Impairment
Lab Test Considerations:
Monitor liver function. May ↑ AST, ALT, CK, bilirubin, and alkaline phosphatase. If therapy is discontinued, may cause severe exacerbation of HBV. Monitor liver function in coinfected patients for several months after stopping therapy.
Lactic acidosis may occur with hepatotoxicity causing hepatic steatosis; may be fatal, especially in women.The dosage of lamivudine for HIV is higher than that used for HBV. If a decision is made to administer lamivudine to patients coinfected with HIV and HBV, the higher dose of lamivudine should be used as part of an appropriate combination regimen.
Do not stop taking without consulting health care provider. Discontinuing therapy may lead to severe exacerbations. Inform patient of importance of HBV testing before starting antiretroviral therapy.
NDC Code