May 25, 2017
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Combivir

"The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.

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Combivir




Indications
Dosage
How Supplied

INDICATIONS

COMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

DOSAGE AND ADMINISTRATION

Recommended Dosage For Adults and Adolescents

The recommended dosage of COMBIVIR in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) taken orally twice daily.

Recommended Dosage For Pediatric Patients

The recommended dosage of scored COMBIVIR tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered orally twice daily.

Before prescribing COMBIVIR tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a COMBIVIR tablet, the liquid oral formulations should be prescribed: EPIVIR® (lamivudine) oral solution and RETROVIR® (zidovudine) syrup.

Not Recommended Due To Lack Of Dosage Adjustment

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

Liquid and solid oral formulations of the individual components of COMBIVIR are available for these populations.

HOW SUPPLIED

Dosage Forms And Strengths

COMBIVIR tablets contain 150 mg of lamivudine and 300 mg of zidovudine. The tablets are white, scored, film-coated, modified capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GX FC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet).

Storage And Handling

COMBIVIR tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:

60 Tablets/Bottle (NDC 49702-202-18).
Unit Dose Pack of 120 (NDC 49702-202-29).

Store between 2° and 30°C (36° and 86°F).

Manufactured for: Viiv Healthcare, Research Triangle Park, NC 27709. By: GlaxoSmithKline Research Triangle Park, NC 27709. Revised: Feb 2017

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

Last reviewed on RxList: 3/13/2017

Indications
Dosage
How Supplied

Combivir - User Reviews

Combivir 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 Combivir 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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