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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.
Pharmacologic: nucleoside reverse transcriptase inhibitors
Time/action profile (blood levels)
|PO||unknown||0.9 hr†||12 hr|
Adverse Reactions/Side EffectsNoted for combination of lamivudine plus zidovudine
Central nervous system
- seizures (life-threatening)
- fatigue (most frequent)
- headache (most frequent)
- insomnia (most frequent)
- malaise (most frequent)
- cough (most frequent)
- hepatomegaly with steatosis (life-threatening)
- pancreatitis (↑ in pediatric patients) (life-threatening)
- anorexia (most frequent)
- diarrhea (most frequent)
- nausea (most frequent)
- vomiting (most frequent)
- abdominal discomfort
- ↑ liver enzymes
- erythema multiforme
Fluid and Electrolyte
- lactic acidosis
- pure red cell aplasia
- musculoskeletal pain (most frequent)
- muscle weakness
- neuropathy (most frequent)
- hypersensitivity reactions including anaphylaxis (life-threatening)
- immune reconstitution syndrome
Drug-Drug interactionTrimethoprim/sulfamethoxazole ↑ levels (dose alteration may be necessary in renal impairment).↑ risk of pancreatitis with concurrent use of other drugs causing pancreatitis.↑ risk of neuropathy with concurrent use of other drugs causing neuropathy.Combination therapy with tenofovir and abacavir may lead to virologic nonresponse and should not be used.
Renal ImpairmentOral (Adults) CCr 30–49 mL/min—150 mg once daily; CCr 15–29 mL/min—150 mg first dose, then 100 mg once daily; CCr 5–14 mL/min—150 mg first dose, then 50 mg once daily; CCr <5 mL/min—50 mg first dose, then 25 mg once daily.
Renal ImpairmentOral (Adults) CCr 30–49 mL/min—100 mg first dose, then 50 mg once daily; CCr 15–29 mL/min—100 mg first dose, then 25 mg once daily; CCr 5–14 mL/min—35 mg first dose, then 15 mg once daily; CCr <5 mL/min—35 mg first dose, then 10 mg once daily.
Availability (generic available)
- Assess patient, especially pediatric patients, for signs of pancreatitis (nausea, vomiting, abdominal pain) periodically during therapy. May require discontinuation of therapy.
- HIV: Assess patient for change in severity of symptoms of HIV infection and for symptoms of opportunistic infection during therapy.
- Monitor patient for signs and symptoms of peripheral neuropathy (tingling, burning, numbness, or pain in hands or feet); may be difficult to differentiate from peripheral neuropathy of severe HIV disease. May require discontinuation of therapy.
- Chronic Hepatitis B Infection: Monitor signs of hepatitis (jaundice, fatigue, anorexia, pruritus) during therapy.
- Lab Test Considerations: Monitor viral load and CD4 levels before and periodically during therapy.
- Monitor serum amylase, lipase, and triglycerides periodically during therapy. Elevated serum levels may indicate pancreatitis and require discontinuation.
- Monitor liver function. May cause ↑ levels of AST, ALT, CPK, bilirubin, and alkaline phosphatase, which usually resolve after interruption of therapy. Lactic acidosis may occur with hepatic toxicity causing hepatic steatosis; may be fatal, especially in women.
- May rarely cause neutropenia and anemia.
Potential Nursing DiagnosesRisk for infection (Indications)
- Do not confuse lamivudine with lamotrigine. Do not confuse Epivir tablets and oral solution with Epivir-HBV tablets and oral solutions. Epivir Tablets and Oral Solution contain a higher dose of the same active ingredient (lamivudine) than in Epivir-HBV Tablets and Oral Solution. Epivir-HBV was developed for patients with hepatitis B and should not be used for patients dually infected with HIV and hepatitis B; use may lead to lamivudine-resistant HIV due to subtherapeutic dose.
- Oral: May be administered without regard to food.
- Instruct patient to take lamivudine as directed, every 12 hr. Explain the difference between Epivir and Epivir-HBV to patients. Emphasize the importance of compliance with full course of therapy, not taking more than the prescribed amount, and not discontinuing without consulting health care professional. Take missed doses as soon as possible unless almost time for next dose. Do not double doses. Caution patient not to share medication with others.
- Inform patient that lamivudine does not cure HIV disease or prevent associated or opportunistic infections. Lamivudine does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and avoid sharing needles or donating blood to prevent spreading HIV to others. Advise patient that the long-term effects of lamivudine are unknown at this time.
- Instruct patient to notify health care professional promptly if signs of peripheral neuropathy or pancreatitis occur.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
- Emphasize the importance of regular follow-up exams and blood tests to determine progress and monitor for side effects.
- Slowing of the progression of HIV infection and its sequelae.
- Decrease in viral load and improvement in CD4 levels in patients with advanced HIV infection.
- Protection from liver damage caused by chronic hepatitis B infection; decreases viral load.