Recommended Topic Related To:

Agenerase Oral Solution

"A new analysis of data from 20 major U.S. cities reveals continued signs of sexual risk among gay and bisexual men, but shows dramatically lower sexual risk among those who accurately know their HIV status. The findings were published today in CD"...

Agenerase Oral Solution

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

AGENERASE (amprenavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The following points should be considered when initiating therapy with AGENERASE:

In a study of NRTI-experienced, protease inhibitor-naive patients, AGENERASE was found to be significantly less effective than indinavir (see DESCRIPTION OF CLINICAL STUDIES).

Mild to moderate gastrointestinal adverse events led to discontinuation of AGENERASE primarily during the first 12 weeks of therapy (see ADVERSE REACTIONS).

There are no data on response to therapy with AGENERASE in protease inhibitor-experienced patients.

AGENERASE Oral Solution (amprenavir oral solution) should be used only when AGENERASE Capsules or other protease inhibitor formulations are not therapeutic options.

DOSAGE AND ADMINISTRATION

AGENERASE may be taken with or without food; however, a high- fat meal decreases the absorption of amprenavir and should be avoided (see CLINICAL PHARMACOLOGY: Effects of Food on Oral Absorption). Adult and pediatric patients should be advised not to take supplemental vitamin E since the vitamin E content of AGENERASE Oral Solution (amprenavir oral solution) exceeds the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU) (see DESCRIPTION).

The recommended dose of AGENERASE Oral Solution (amprenavir oral solution) based on body weight and age is shown in Table 12. Consideration should be given to switching patients from AGENERASE Oral Solution (amprenavir oral solution) to AGENERASE Capsules as soon as they are able to take the capsule formulation (see WARNINGS).

Table 12. Recommended Dosages of AGENERASE Oral Solution (amprenavir oral solution)

Age/Weight Criteria Dose
b.i.d. t.i.d.
4 - 12 years or 13 - 16 years and < 50 kg 22.5 mg/kg (1.5 mL/kg)
(maximum dose 2,800 mg per day)
17 mg/kg (1.1 mL/kg)
(maximum dose 2,800 mg per day)
13 - 16 years and ≥ 50 kg or > 16 years 1,400 mg NA

Concomitant Therapy: Concurrent use of AGENERASE Oral Solution (amprenavir oral solution) and NORVIR (ritonavir) Oral Solution is not recommended because the large amount of propylene glycol in AGENERASE Oral Solution (amprenavir oral solution) and ethanol in NORVIR Oral Solution may compete for the same metabolic pathway for elimination.

Patients with Hepatic Impairment: AGENERASE Oral Solution (amprenavir oral solution) is contraindicated in patients with hepatic failure (see CONTRAINDICATIONS).

Patients with hepatic impairment are at increased risk of propylene glycol-associated adverse events (see WARNINGS). AGENERASE Oral Solution (amprenavir oral solution) should be used with caution in patients with hepatic impairment. Based on a study with AGENERASE Capsules, adult patients with a Child-Pugh score ranging from 5 to 8 should receive a reduced dose of AGENERASE Oral Solution (amprenavir oral solution) of 513 mg (34 mL) twice daily, and adult patients with a Child-Pugh score ranging from 9 to 12 should receive a reduced dose of AGENERASE Oral Solution of 342 mg (23 mL) twice daily (see CLINICAL PHARMACOLOGY: Hepatic Insufficiency).

AGENERASE Oral Solution (amprenavir oral solution) has not been studied in children with hepatic impairment.

Renal Insufficiency: AGENERASE Oral Solution (amprenavir oral solution) is contraindicated in patients with renal failure (see CONTRAINDICATIONS).

Patients with renal impairment are at increased risk of propylene glycol-associated adverse events. AGENERASE Oral Solution (amprenavir oral solution) should be used with caution in patients with renal impairment (see WARNINGS).

AGENERASE Capsules and AGENERASE Oral Solution (amprenavir oral solution) are not interchangeable on a milligram-per-milligram basis (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

AGENERASE Oral Solution (amprenavir oral solution) , a clear, pale yellow to yellow, grape-bubblegum-peppermint- flavored liquid, contains 15 mg of amprenavir in each 1 mL.

Bottles of 240 mL with child-resistant closures (NDC 0173-0687-00). This product does not require reconstitution.

Store at controlled room temperature of 25°C (77°F) (see USP).

GlaxoSmithKline, Research Triangle Park, NC 27709. Licensed from: Vertex Pharmaceuticals Incorporated, Cambridge, MA 02139. AGENERASE is a registered trademark of GlaxoSmithKline. May 2005. FDA rev date: 11/4/2005

Last reviewed on RxList: 7/18/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

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.


WebMD Daily

Get breaking medical news.