Epivir (Lamivudine) - Indications and Dosage

INDICATIONS AND USAGE

EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.

DOSAGE AND ADMINISTRATION

Adults and Adolescents >16 years of age

The recommended oral dose of EPIVIR in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions].

Pediatric Patients

The recommended oral dose of EPIVIR Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.

EPIVIR is also available as a scored tablet for HIV-1-infected pediatric patients who weigh ≥14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow EPIVIR Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of EPIVIR Tablets for HIV-1-infected pediatric patients is presented in Table 1.

Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients

Weight (kg)	Dosage Regimen Using Scored 150-mg Tablet		Total Daily Dose
	AM Dose	PM Dose
14 to 21	½ tablet (75 mg)	½ tablet (75 mg)	150 mg
>21 to <30	½ tablet (75 mg)	1 tablet (150 mg)	225 mg
≥30	1 tablet (150 mg)	1 tablet (150 mg)	300 mg

Patients With Renal Impairment

Dosing of EPIVIR is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see Clinical Pharmacology].

Table 2. Adjustment of Dosage of EPIVIR in Adults and Adolescents (≥30 kg) in Accordance With Creatinine Clearance

Creatinine Clearance (mL/min)	Recommended Dosage of EPIVIR
≥50	150 mg twice daily or 300 mg once daily
30-49	150 mg once daily
15-29	150 mg first dose, then 100 mg once daily
5-14	150 mg first dose, then 50 mg once daily
<5	50 mg first dose, then 25 mg once daily

No additional dosing of EPIVIR is required after routine (4-hour) hemodialysis or peritoneal dialysis.

Although there are insufficient data to recommend a specific dose adjustment of EPIVIR in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

DOSAGE FORMS AND STRENGTHS

• EPIVIR Scored Tablets

  150 mg, are white, diamond-shaped, scored, film-coated tablets debossed with “GX CJ7â€� on both sides.

• EPIVIR Tablets

  300 mg, are gray, modified diamond-shaped, film-coated tablets engraved with “GX EJ7â€� on one side and plain on the reverse side.

• EPIVIR Oral Solution

  A clear, colorless to pale yellow, strawberry-banana flavored liquid, containing 10 mg of lamivudine per 1 mL.

HOW SUPPLIED/STORAGE AND HANDLING

EPIVIR Scored Tablets, 150 mg

White, diamond-shaped, scored, film-coated tablets debossed with “GX CJ7� on both sides.

Bottle of 60 tablets (NDC 0173-0470-01) with child-resistant closure.

EPIVIR Tablets, 300 mg

Gray, modified diamond-shaped, film-coated tablets engraved with “GX EJ7� on one side and plain on the reverse side.

Bottle of 30 tablets (NDC 0173-0714-00) with child-resistant closure.

Recommended Storage:

Store EPIVIR Tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

EPIVIR Oral Solution, 10 mg/mL

A clear, colorless to pale yellow, strawberry-banana-flavored liquid, contains 10 mg of lamivudine in each 1 mL.

Plastic bottle of 240 mL (NDC 0173-0471-00) with child-resistant closure. This product does not require reconstitution.

Recommended Storage:

Store in tightly closed bottles at 25°C (77°F) [see USP Controlled Room Temperature].