August 27, 2016
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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 type 1 (HIV-1) infection.

Limitations Of Use

  • The dosage of this product is for HIV-1 and not for HBV.

DOSAGE AND ADMINISTRATION

Recommended Dosage For Adult Patients

The recommended dosage of EPIVIR in HIV-1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. 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].

Recommended Dosage For Pediatric Patients

The recommended dosage of EPIVIR oral solution in HIV-1-infected pediatric patients aged 3 months and older is 4 mg per kg taken orally twice daily or 8 mg per kg taken orally once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

EPIVIR scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow EPIVIR tablets, the oral solution formulation should be prescribed [see WARNINGS AND PRECAUTIONS]. The recommended oral dosage of EPIVIR tablets for HIV-1-infected pediatric patients is presented in Table 1.

Table 1: Dosing Recommendations for EPIVIR Scored (150-mg) Tablets in Pediatric Patients

Weight (kg) Once-Daily Dosing Regimena Twice-Daily Dosing Regimen Using Scored 150-mg Tablet
AM Dose PM Dose Total Daily Dose
14 to < 20 1 tablet
(150 mg)
½tablet
(75 mg)
/ tablet
(75 mg)
150 mg
≥20 to < 25 1½ tablets
(225 mg)
½ tablet
(75 mg)
1 tablet
(150 mg)
225 mg
> 25 2 tablets
(300 mg)b
1 tablet
(150 mg)
1 tablet
(150 mg)
300 mg
a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies].
b Patients may alternatively take one 300-mg tablet, which is not scored.

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 25 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 Scored Tablets

EPIVIR scored tablets contain 150 mg of lamivudine. The tablets are white, diamond-shaped, scored, film-coated tablets debossed with “GX CJ7” on both sides.

EPIVIR Tablets

EPIVIR tablets contain 300 mg of lamivudine. The tablets are gray, modified diamond-shaped, film-coated, and engraved with “GX EJ7” on one side and plain on the reverse side.

EPIVIR Oral Solution

EPIVIR oral solution contains 10 mg of lamivudine per 1 mL. The solution is a clear, colorless to pale yellow, strawberry-banana flavored liquid.

Storage And Handling

EPIVIR scored tablets contain 150 mg of lamivudine, are white, diamond-shaped, film-coated, and debossed with “GX CJ7” on both sides. Packaged as follows:

Bottle of 60 tablets (NDC 49702-203-18) with child-resistant closure.

EPIVIR tablets contain 300 mg of lamivudine, are gray, modified diamond-shaped, film-coated, and engraved with “GX EJ7” on one side and plain on the reverse side. Packaged as follows:

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 is a clear, colorless to pale yellow, strawberry-banana-flavored liquid. Each mL of the solution contains 10 mg of lamivudine. Packaged as follows:

Plastic bottle of 240 mL (NDC 49702-205-48) with child-resistant closure. This product does not require reconstitution.

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

Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709. Manufactured under agreement from Shire Pharmaceuticals Group plc, Basingstoke, UK. Revised: July 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/29/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

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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