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Pharmacologic class: Nucleoside reverse transcriptase inhibitor
Therapeutic class: Antiretroviral
Pregnancy risk category C
FDA Box Warning
• Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have occurred when drug was used alone or in combination with other nucleoside analogues.
• Epivir tablets and oral solution (used to treat human immunodeficiency virus [HIV] infection) contain higher dose of active ingredient (lamivudine) than Epivir-HBV tablets and oral solution (used to treat chronic hepatitis B). Patients with HIV should receive only dosing forms appropriate for HIV treatment.
• After Epivir discontinuation, severe acute hepatitis B exacerbations have occurred in patients co-infected with hepatitis B virus (HBV) and HIV. Monitor hepatic function closely for at least several months in these patients. If appropriate, begin anti-hepatitis B therapy.
Inhibits HIV reverse transcription by viral DNA chain termination. Impedes RNA- and DNA-dependent DNA polymerase activities.
Oral solution: 5 mg/ml and 10 mg/ml in 240-ml bottles
Tablets: 100 mg, 150 mg, 300 mg
Indications and dosages
➣ HIV infection (given with other antiretrovirals)
Adults and children older than age 16: 150 mg P.O. b.i.d. or 300 mg P.O. daily
Children ages 3 months to 16 years: 4 mg/kg P.O. b.i.d. to a maximum of 150 mg P.O. b.i.d.
➣ Chronic HBV
Adults: 100 mg (Epivir-HBV) P.O. once daily
Children ages 2 to 17: 3 mg/kg (Epivir-HBV) P.O. once daily, to a maximum of 100 mg P.O. daily
• Renal impairment
• Hypersensitivity to drug or its components
Use cautiously in:
• impaired renal function, history of hepatic disease, obesity, granulocyte count below 1,000/mm3
• long-term therapy
• elderly patients
• women (especially if pregnant)
• Give with or without food.
☞ Be aware that Epivir contains 150 mg lamivudine and Epivir-HBV contains 100 mg lamivudine. Strengths are not interchangeable.
☞ Know that when given to patients with unrecognized or untreated HIV, Epivir-HBV is likely to cause rapid emergence of HIV resistance.
CNS: fatigue, headache, insomnia, malaise, asthenia, depression, dizziness, paresthesia, peripheral neuropathy, seizures
GI: nausea, vomiting, diarrhea, anorexia, abdominal discomfort, dyspepsia, splenomegaly, pancreatitis
Hematologic: anemia, neutropenia
Hepatic: hepatomegaly with steatosis
Metabolic: hyperglycemia, lactic acidosis
Musculoskeletal: muscle, joint, or bone pain; muscle weakness; myalgia; rhabdomyolysis
Respiratory: cough, abnormal breath sounds, wheezing
Skin: alopecia, rash, urticaria, erythema multiforme, Stevens-Johnson syndrome
Other: lymphadenopathy, body fat redistribution, hypersensitivity reactions including anaphylaxis; immune reconstitution syndrome
Drug-drug. Co-trimoxazole: increased lamivudine blood level
Zalcitabine: interference with effects of both drugs
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, creatine kinase, liver function tests: increased levels
Hemoglobin, hematocrit, neutrophils: decreased levels
• Check vital signs regularly.
• Monitor CBC and platelet count frequently. Watch for evidence of bone marrow toxicity.
• Monitor blood glucose level and kidney and liver function test results.
• Assess neurologic and mental status. Report signs or symptoms of depression.
• Closely monitor obese patients, women, and patients with a history of hepatic disease; they're at increased risk for lactic acidosis and severe hepatomegaly with steatosis.
• Monitor HIV patients for co-infection with HBV (which may recur when drug is withdrawn).
☞ Monitor patients for signs and symptoms of immune reconstitution syndrome.
• Tell patient he may take with or without food.
• Advise patient to minimize GI upset by eating small, frequent servings of healthy food and drinking plenty of fluids.
• Tell HIV patient that drug doesn't cure virus or prevent its transmission and that opportunistic infections may occur. Advise him to take appropriate precautions during sex.
• Teach patient how to recognize and immediately report signs and symptoms of immune reconstitution syndrome.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Caution HIV patient not to breastfeed, because of risk of passing infection to infant.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
lamivudine/la·miv·u·dine/ (lah-miv´u-dēn) a nucleoside analogue that inhibits reverse transcriptase, used as an antiviral agent in the treatment of chronic hepatitis B and, in combination with zidovudine, the treatment of HIV infection and AIDS.
lamivudine®Epivir, 3TC AIDS An anti-HIV nucleoside analogue with activity against HBV Adverse effects Headache, nausea, ↓ WBCs, rare alopecia. See AIDS, HIV.
lamivudineA reverse transcriptase inhibitor drug used to treat infections with retroviruses, such as HIV. The drug has also been used to treat hepatitis. The drug is on the WHO official list. A brand name is Epivir.
drug class: antiviral, nucleoside analog;
action: inhibition of HIV reverse transcriptase; also inhibits RNA- and DNA-dependent DNA polymerase;
use: in combination with zidovudine for the treatment of HIV infection.