Buy Epivir Online

Epivir (lamivudine)

BOXED WARNING

Lactic acidosis and severe hepatomegaly w/ steatosis, including fatal cases, reported w/ nucleoside analogues; suspend treatment if lactic acidosis or pronounced hepatotoxicity occurs. Severe acute exacerbations of hepatitis B reported in patients coinfected w/ hepatitis B virus (HBV) upon discontinuation of therapy; closely monitor hepatic function for at least several months. If appropriate, initiation of antihepatitis B therapy may be warranted. Epivir tabs and sol (used to treat HIV-1 infection) contain a higher dose of lamivudine than Epivir-HBV tabs and sol (used to treat chronic HBV infection); patients w/ HIV-1 infection should only receive dosage forms appropriate for HIV-1 treatment.

View FDA-Approved Full Prescribing Information for Epivir

THERAPEUTIC CLASS

Nucleoside reverse transcriptase inhibitor (NRTI)

DEA CLASS

RX

INDICATIONS

Treatment of HIV-1 infection in combination w/ other antiretrovirals.

ADULT DOSAGE

HIV-1 Infection

In Combination w/ Other Antiretrovirals:
150mg bid or 300mg qd

If lamivudine is administered to a patient infected w/ HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen

PEDIATRIC DOSAGE

HIV-1 Infection

In Combination w/ Other Antiretrovirals:
≥3 Months:
Sol:
4mg/kg bid or 8mg/kg qd
Max: 300mg/day

Tab:
QD Dosing Regimen:
14 to <20kg: 150mg
≥20 to <25kg: 225mg
≥25kg: 300mg

BID Dosing Regimen (Using Scored 150mg Tab):
14 to <20kg:
AM Dose: 75mg
PM Dose: 75mg
≥20 to <25kg:
AM Dose: 75mg
PM Dose: 150mg
≥25kg:
AM Dose: 150mg
PM Dose: 150mg

DOSING CONSIDERATIONS

Renal Impairment
Adults and Adolescents ≥25kg:
CrCl 30-49mL/min: 150mg qd
CrCl 15-29mL/min: 150mg 1st dose, then 100mg qd
CrCl 5-14mL/min: 150mg 1st dose, then 50mg qd
CrCl <5mL/min: 50mg 1st dose, then 25mg qd

No additional dosing is required after routine (4-hr) hemodialysis or peritoneal dialysis

Pediatric Patients:
Consider dose reduction and/or increase in dosing interval

ADMINISTRATION

Oral route

Take w/ or w/o food.

HOW SUPPLIED

Oral Sol: 10mg/mL [240mL]; Tab: 150mg*, 300mg *scored

WARNINGS/PRECAUTIONS

Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly w/ steatosis. Caution w/ known risk factors for liver disease. Emergence of lamivudine-resistant HBV reported. Caution in pediatric patients w/ a history of prior antiretroviral nucleoside exposure, history of pancreatitis, or other significant risk factors for development of pancreatitis; d/c if pancreatitis develops. Immune reconstitution syndrome reported. Autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre syndrome) reported to occur in the setting of immune reconstitution and can occur many months after initiation of treatment. Redistribution/accumulation of body fat may occur. Caution in elderly.

ADVERSE REACTIONS

Headache, malaise, fatigue, N/V, diarrhea, nasal signs/symptoms, neuropathy, insomnia, musculoskeletal pain, cough, fever, dizziness.

DRUG INTERACTIONS

Not recommended w/ other lamivudine- and emtricitabine-containing products, and zalcitabine. Hepatic decompensation reported in HIV-1/hepatitis C virus coinfected patients receiving antiretroviral therapy for HIV-1 and interferon-alfa w/ or w/o ribavirin; closely monitor for treatment-associated toxicities during coadministration. Possible interaction w/ drugs whose main route of elimination is active renal secretion via the organic cationic transport system (eg, trimethoprim).

PREGNANCY AND LACTATION

Pregnancy: Physicians are encouraged to register patients in the Antiretroviral Pregnancy Registry. Embryonic toxicity produced in rabbits at a dose that produced similar human exposures as the recommended clinical dose; relevance to human pregnancy registry data is unknown.
Lactation: Mothers should be instructed not to breastfeed due to potential for HIV-1 transmission.

MECHANISM OF ACTION

Nucleoside analogue. Lamivudine is phosphorylated to its active 5'-triphosphate metabolite, lamivudine triphosphate (3TC-TP); 3TC-TP inhibits HIV-1 reverse transcriptase via DNA chain termination after incorporation of the nucleotide analogue into viral DNA.

PHARMACOKINETICS

Absorption: Rapid; absolute bioavailability (86% for tab, 87% for sol); Cmax=1.5mcg/mL; Tmax=0.9 hrs (fasting), 3.2 hrs (fed). Distribution: Vd=1.3L/kg (IV); plasma protein binding (<36%); crosses placenta. Metabolism: Trans-sulfoxide (metabolite). Elimination: Urine (71% unchanged [IV], 5.2% as metabolite [oral]); T1/2=5-7 hrs.

ASSESSMENT

Assess for renal impairment, risk factors for lactic acidosis and liver disease, HIV-1 and HBV coinfection, previous hypersensitivity, pregnancy/nursing status, and possible drug interactions. In pediatric patients, assess for a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or risk factors for pancreatitis. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment w/ oral sol.

MONITORING

Monitor for signs/symptoms of pancreatitis, immune reconstitution syndrome, autoimmune disorders, fat redistribution/accumulation, lactic acidosis, hepatomegaly w/ steatosis, hepatitis B exacerbation, renal dysfunction, and hypersensitivity reactions. Monitor hepatic function closely for several months in patients w/ HIV/HBV coinfection who d/c therapy. Monitor CBC.

PATIENT COUNSELING

Inform that drug may cause a rare, but serious condition called lactic acidosis w/ liver enlargement. Instruct to discuss any changes in regimen w/ physician. Instruct not to take concomitantly w/ emtricitabine- or other lamivudine-containing products. Advise parents or guardians of pediatric patients to monitor for signs and symptoms of pancreatitis. Advise that drug is not a cure for HIV-1 infection and continuous therapy is necessary to control HIV-1 infection and decrease HIV-related illness. Inform that redistribution/accumulation of body fat may occur. Advise diabetic patients that each 15mL dose of sol contains 3g of sucrose. Advise to avoid doing things that can spread HIV-1 to others. Inform to take all HIV medications exactly as prescribed.

STORAGE

(Tab) 25°C (77°F); excursions permitted to 15-30°C (59-86°F). (Sol) 25°C (77°F).

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