Agenerase Oral Solution

(Generic versions may still be available.)

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 »


Agenerase Oral Solution Patient Information Including Side Effects

Brand Names: Agenerase

Generic Name: amprenavir (Pronunciation: am PREN a veer)

  • What is amprenavir (Agenerase Oral Solution)?
  • What are the possible side effects of amprenavir (Agenerase Oral Solution)?
  • What is the most important information I should know about amprenavir (Agenerase Oral Solution)?
  • What should I discuss with my healthcare provider before taking amprenavir (Agenerase Oral Solution)?
  • How should I take amprenavir (Agenerase Oral Solution)?
  • What happens if I miss a dose (Agenerase Oral Solution)?
  • What happens if I overdose (Agenerase Oral Solution)?
  • What should I avoid while taking amprenavir (Agenerase Oral Solution)?
  • What other drugs will affect amprenavir (Agenerase Oral Solution)?
  • Where can I get more information?

What is amprenavir (Agenerase Oral Solution)?

Amprenavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Amprenavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Amprenavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Amprenavir is not a cure for HIV or AIDS.

Amprenavir may also be used for purposes other than those listed in this medication guide.

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

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;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms; or
  • seizures, muscle pain and weakness, fast heart rate, numbness or cold feeling in your arms or legs (while using amprenavir oral liquid).

Keep taking the medication and talk with your doctor if you have any of these less serious side effects:

  • nausea, vomiting, diarrhea, stomach pain;
  • numbness or tingling, especially around your mouth;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about amprenavir (Agenerase Oral Solution)?

Do not take amprenavir with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine, and others. These drugs can cause life-threatening side effects if you use them while you are taking amprenavir.

Amprenavir oral liquid should also not be taken with disulfiram (Antabuse) or metronidazole (Flagyl).

There are many other medicines that can interact with amprenavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking amprenavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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