July 30, 2016
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Epzicom

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Epzicom




Indications
Dosage
How Supplied

INDICATIONS

EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

DOSAGE AND ADMINISTRATION

Screening For HLA-B*5701 Allele Prior To Starting EPZICOM

Screen for the HLA-B*5701 allele prior to initiating therapy with EPZICOM [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Recommended Dosage For Adult Patients

The recommended dosage of EPZICOM for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food.

Recommended Dosage For Pediatric Patients

The recommended oral dose of EPZICOM for pediatric patients weighing at least 25 kg is one tablet daily in combination with other antiretroviral agents [see Clinical Studies]. Before prescribing EPZICOM tablets, pediatric patients should be assessed for the ability to swallow tablets.

Not Recommended Due To Lack of Dosage Adjustment

Because EPZICOM is a fixed-dose tablet and cannot be dose adjusted, EPZICOM is not recommended for:

Use of EPIVIR® (lamivudine) oral solution or tablets and ZIAGEN® (abacavir) oral solution may be considered.

HOW SUPPLIED

Dosage Forms And Strengths

EPZICOM tablets contain 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are modified capsule-shaped, orange, film-coated, and debossed with “GS FC2” on one side with no markings on the reverse side.

Storage And Handling

EPZICOM is available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange, film-coated, modified capsule-shaped, and debossed with GS FC2 on one side with no markings on the reverse side. They are packaged as follows:

Bottles of 30 tablets (NDC 49702-206-13).

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

Manufactured for : ViiV Healthcare, Research Triangle Park, NC 27709. by: GlaxoSmithKline Research Triangle Park, NC 27709. Revised: September 2015

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

Last reviewed on RxList: 10/23/2015

Indications
Dosage
How Supplied

Epzicom - User Reviews

Epzicom User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Epzicom sorted by most helpful. Patient Discussions FAQs

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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