Agenerase Oral Solution (Amprenavir Oral Solution) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 23, 2012

Agenerase Oral Solution

HIV and AIDS: Antiretroviral Drugs, Treatments and Medications »

Entry Inhibitors (including Fusion Inhibitors) and CCR5 Co-receptor Antagonist

Entry Inhibitors
Entry inhibitors block HIV entry into CD4+ cells.

Fusion inhibitors
The only drug in this class is T-20, which is administered as a twice daily subcutaneous injection. The most common side effect is redness and pain at the site of injection. Rarely, infection can occur at the injection site. There also are reports of generalized allergic reactions.

CCR5 antagonist
Although there were some early concerns of liver inflammation for drugs in this class, MVC appeared to be well tolerated in clinical trials without any specific toxicities attributable to the drug. However, it is a new drug in a new class and the first to actually target the cell. For these reasons, longer follow-up from clinical trials and those followed in the clinic will be very important for assessing the overall safety of the...

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Agenerase Oral Solution

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

AGENERASE®
(amprenavir) Oral Solution

Because of the potential risk of toxicity from the large amount of the excipient, propylene glycol, AGENERASE Oral Solution (amprenavir oral solution) is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic or renal failure, and patients treated with disulfiram or metronidazole (see CONTRAINDICATIONS AND WARNINGS). AGENERASE Oral Solution (amprenavir oral solution) should be used only when AGENERASE Capsules or other protease inhibitor formulations are not therapeutic options.

DRUG DESCRIPTION

AGENERASE (amprenavir) is an inhibitor of the human immunodeficiency virus (HIV) protease. The chemical name of amprenavir is (3S)-tetrahydro-3-furyl N-[(1S,2R)-3-(4-amino-N-isobutylbenzenesulfonamido)-1-benzyl-2-hydroxypropyl]carbamate. Amprenavir is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C₂₅H₃₅N₃O₆S and a molecular weight of 505.64. It has the following structural formula:

AGENERASE® (amprenavir) Structural Formula Illustration

Amprenavir is a white to cream-colored solid with a solubility of approximately 0.04 mg/mL in water at 25°C.

AGENERASE Oral Solution (amprenavir oral solution) is for oral administration. One milliliter (1 mL) of AGENERASE Oral Solution contains 15 mg of amprenavir in solution and the inactive ingredients acesulfame potassium, artificial grape bubblegum flavor, citric acid (anhydrous), d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), menthol, natural peppermint flavor, polyethylene glycol 400 (PEG 400) (170 mg), propylene glycol (550 mg), saccharin sodium, sodium chloride, and sodium citrate (dihydrate). Solutions of sodium hydroxide and/or diluted hydrochloric acid may have been added to adjust pH. Each mL of AGENERASE Oral

Solution contains 46 IU vitamin E in the form of TPGS. Propylene glycol is in the formulation to achieve adequate solubility of amprenavir. The recommended daily dose of AGENERASE Oral Solution (amprenavir oral solution) of 22.5 mg/kg twice daily corresponds to a propylene glycol intake of 1,650 mg/kg/day. Acceptable intake of propylene glycol for pharmaceuticals has not been established.

What are the possible side effects of amprenavir (Agenerase)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking amprenavir and call your doctor at once if you have any of these serious side effects:

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
pale or yellowed skin, dark colored urine, fever, confusion or weakness;
increased urination or extreme thirst;
easy bruising or bleeding;

Read All Potential Side Effects and See Pictures of Agenerase Oral Solution »

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