July 4, 2015
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Epivir

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Epivir




Indications
Dosage
How Supplied

INDICATIONS

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

Adult Patients

The recommended oral dose of EPIVIR in HIV-1-infected adults and adolescents older than 16 years 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 aged 3 months to 16 years is 4 mg per 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 at least 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 (Greater than or Equal to 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.

HOW SUPPLIED

Dosage Forms And Strengths

  • EPIVIR Functionally Scored Tablets
    150 mg, are white, diamond-shaped, functionally scored, film-coated tablets debossed with “GX CJ7” on both sides.
  • EPIVIR Tablets
    300 mg, are gray, modified diamond-shaped, film-coated tablets engraved with “GX EJ7” 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.

Storage And Handling

EPIVIR Functionally Scored Tablets, 150 mg

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

Bottle of 60 tablets (NDC 49702-203-18) 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 49702-204-13) 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 per 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 49702-205-48) 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].

Manufactured for: VnV Healthcare, Research Triangle Park, NC 27709. by:GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Feb 2015

Last reviewed on RxList: 3/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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