Epivir


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Related to Epivir: Prevacid, lansoprazole, lamivudine

lamivudine

Epivir, Epivir-HBV, 3TC (CA), Heptovir (CA), Zeffix (UK)

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.

Action

Inhibits HIV reverse transcription by viral DNA chain termination. Impedes RNA- and DNA-dependent DNA polymerase activities.

Availability

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

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug or its components

Precautions

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)
• children.

Administration

• 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.

Adverse reactions

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

Interactions

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

Patient monitoring

• 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.

Patient teaching

• 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.

Epivir

(ĕp′ĭ-vîr′)
A trademark for the drug lamivudine.

Epivir®

Heptodin®, Lamivudine Virology An antiviral used with other agents–eg, zidovudine–Retrovir®, to manage HIV and HBV infections Toxicity Renal toxicity. See HAART, Lamivudine.

Epivir

A brand name for LAMIVUDINE.
References in periodicals archive ?
Lupin s Lamivudine tablets 150 mg and 300 mg are the AB-rated generic equivalents of ViiV Healthcare s Epivir tablets and are denoted in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
When the researchers considered people with virologic failure or a change in treatment with Ziagen, Viread, Epivir, or Emtriva, there were 114 failures or drug changes in the Epzicom group and 68 in the Truvada group.
Protease Inhibitors Nucleotide Reverse Agenerase (generic name: amprenavir) Transcriptase Inhibitor Crixivan (indinavir) Viread (tenofovir, PMPA) Fortovase (saquinavir) Kaletra (lopinavir plus ritonavir) Nucleoside Reverse Norvir (ritonavir) Transcriptase Inhibitors Viracept (nelfinavir) Combivir (AZT plus 3TC) Epivir (lamivudine, also Nonnucleoside Reverse known as 3TC) Transcriptase Inhibitors Hivid (zalcitabine, ddC) Rescriptor (delavirdine) Retrovir (zidovudine, AZT) Sustiva (efavirenz) Trizivir (abacavir plus AZT plus 3TC) Viramune (nevirapine) Videx (didanosine, ddl) Zerit (stavudine, d4T) Ziagen (abacavir)
The sales of new drugs such as Atripla have increased by a CAGR of 136% over the last three years; other drugs such as Trizivir, Relenza and Epivir have declined by a CAGR of 11%, 21% and 17% respectively.
Almost all study participants took an antiretroviral active against HBV at some time during the study period: Epivir (lamivudine), Emtriva (emtricitabine), or Viread (tenofovir).
Lamivudine, which is active against HIV and HBV is marketed by GlaxoSmithKline as Epivir for HIV infection and as Epivir-HBV for hepatitis B infection.
M2 EQUITYBITES-April 7, 2016-Mylan unveils generic Epivir Tablets for treating HIVa[euro]'1 infection
M2 PHARMA-April 7, 2016-Mylan unveils generic Epivir Tablets for treating HIVa[euro]'1 infection
5 (intermediate 0 (low penetration) penetration) Nucleoside or nucleotide reverse transcriptase inhibitors Retrovir (zidovudine) Emtriva Videx (didanosine) (emtricitabine) Ziagen (abacavir) Epivir (lamivudine) Viread (tenofovir) Zerit (stavudine) Nonnucleoside reverse transcriptase inhibitors Viramune (nevirapine) Sustiva (efavirenz) Intelence (etravirine) * Protease inhibitors Crixivan (indinavir) Reyataz (atazanavir) Aptivus (tipranavir) + (+ RTV) RTV Kaletra (lopinavir + Reyataz + RTV Invirase (saquinavir) RTV) + RTV Agenerase[dagger] Prezista (darunavir) + Norvir (ritonavir) (amprenavir) + RTV RTV Viracept (nelfinavir) Entry inhibitors Selzentry Fuzeon (enfuvirtide) (maraviroc) * Integrase inhibitors Isentress (raltegravir) * RTV = ritonavir (Norvir).
Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are the generic versions of GlaxoSmithKline's (LON:GSK) Epivir, Gilead Sciences' (NASDAQ:GILD) Viread and Boehringer Ingelheim's Viramune, respectively.
The other failing combinations were three- or four-drug nucleoside combinations, such as Retrovir (zidovudine) plus Epivir (lamivudine) plus Ziagen (abacavir).
Other approved treatments are interferon alfa 2b and Epivir (lamivudine).