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All about: Agenerase Solution

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Generic Name: Amprenavir Oral Solution (am-PREN-ah-veer)
Brand Name: Agenerase

This form of amprenavir contains propylene glycol. Therefore, it must not be used in infants and children younger than 4 years of age, pregnant women, patients with severe kidney or liver problems, or in patients who take disulfiram or metronidazole. The oral solution form of amprenavir should be used only if other treatment options are not available.

Agenerase Solution is used for:

Treating HIV infection. Agenerase Solution is used in combination with other medicines.

Agenerase Solution is an HIV-protease inhibitor. It works by inhibiting the growth of HIV.

Do NOT use Agenerase Solution if:

  • you are allergic to any ingredient in Agenerase Solution
  • you have severe kidney or liver problems
  • you are pregnant
  • you are taking astemizole, cisapride, delavirdine, disulfiram, an ergot derivative (eg, ergotamine), eletriptan, erythromycin, certain HMG-CoA reductase inhibitors (lovastatin, simvastatin), metronidazole, midazolam, nevirapine, an oral contraceptive (birth control pills), pimozide, a quinazoline (eg, alfuzosin), rifampin, St. John's wort, sumatriptan, terfenadine, or triazolam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Agenerase Solution:

Some medical conditions may interact with Agenerase Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
  • if you have diabetes, hemophilia or other bleeding disorders, high cholesterol or triglyceride levels, high blood sugar, liver disease, skin rash, or kidney problems

Some MEDICINES MAY INTERACT with Agenerase Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine, dexamethasone, methadone, non-nucleoside reverse transcriptase inhibitors (NNRTIs) (eg, efavirenz, nevirapine), oral contraceptives (birth control pills ), phenobarbital, phenytoin, rifampin, saquinavir, or St. John's wort because the effectiveness of Agenerase Solution may be decreased
  • HIV protease inhibitors (eg, indinavir, ritonavir) because the actions and side effects of Agenerase Solution may be increased
  • Astemizole, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, eletriptan, ergot derivatives (eg, ergotamine), erythromycin, midazolam, pimozide, quinazolines (eg, alfuzosin), sumatriptan, terfenadine, or triazolam because the risk of side effects may be increased by Agenerase Solution
  • Aldosterone blockers (eg, eplerenone), antiarrhythmics (eg, amiodarone, bepridil, flecainide, lidocaine, propafenone, quinidine), azole antifungals (eg, itraconazole, ketoconazole), benzodiazepines (eg, alprazolam), calcium channel blockers (eg, diltiazem, amlodipine), fluoxetine, fluticasone, immunosuppressants (eg, cyclosporine, tacrolimus), muscarinic receptor antagonists (eg, darifenacin), narcotic analgesics (eg, fentanyl), rifabutin, sildenafil, trazodone, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects may be increased by Agenerase Solution
  • Delavirdine because effectiveness may be decreased by Agenerase Solution
  • Anticoagulants (eg, warfarin) because actions and effectiveness may be altered by Agenerase Solution
  • Disulfiram or metronidazole because risk of serious side effects, including flushing, headache, vomiting, or irregular heartbeat, may be increased by Agenerase Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Agenerase Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Agenerase Solution:

Use Agenerase Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Agenerase Solution may be taken with or without food. If you take it with food, do not take it with a high fat meal.
  • Agenerase Solution comes with an additional patient leaflet. Read it carefully and reread it each time you get Agenerase Solution refilled.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Do not take antacids or a buffered form of didanosine within 1 hour before or 1 hour after taking Agenerase Solution.
  • Continue to use Agenerase Solution even if you feel well. Do not miss any doses.
  • Amprenavir oral solution should only be used if you cannot take amprenavir capsules. Amprenavir oral solution contains propylene glycol, which may cause side effects in some patients.
  • Do not switch between the capsule and liquid forms of Agenerase Solution. They are not equal milligram to milligram. Consult with your doctor or pharmacist.
  • If you miss a dose of Agenerase Solution, take it as soon as possible. If you miss a dose by more than 4 hours, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Agenerase Solution. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Agenerase Solution.

Important safety information:

  • Do not drink alcohol while you are using Agenerase Solution.
  • Agenerase Solution is not a cure for HIV infection and patients may continue to acquire illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Agenerase Solution may not prevent other infections. If your health changes, check with your doctor.
  • When your medicine supply begins to run low, get more from your doctor or pharmacist as soon as possible. The virus may develop resistance to Agenerase Solution and become more difficult to treat if you stop taking it, even for a short period of time.
  • Agenerase Solution offers no protection from the transmission of HIV to others through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) if you are infected with HIV. Do not share needles, other injection equipment, or personal items such as toothbrushes or razor blades.
  • Certain birth control pills may decrease the effectiveness of Agenerase Solution. Women should not take birth control pills and should use additional or other birth control measures (eg, condoms, diaphragms) while taking Agenerase Solution.
  • Do not take vitamin E supplements while you are taking Agenerase Solution. Agenerase Solution already contains vitamin E.
  • Women, Asians, Eskimos, and Native Americans may be at increased risk of the side effects associated with taking Agenerase Solution. Ask your doctor for more information.
  • Agenerase Solution may cause high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, fruity breath odor). If these symptoms occur, tell your doctor immediately.
  • Changes in body fat may occur in some patients taking this type of medicine. These changes may include increased amount of fat in the upper back and neck, breast, and around the trunk, and loss of fat from the legs, arms, and face. The cause and long-term effects are unknown. Discuss any concerns with your doctor.
  • LAB TESTS, including liver function, blood cholesterol or triglyceride levels, and white blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Agenerase Solution with caution in the ELDERLY because they may be more sensitive to its effects.
  • Agenerase Solution is not recommended for use in CHILDREN younger than 4 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Agenerase Solution if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Agenerase Solution is excreted in breast milk. Do not breast-feed while taking Agenerase Solution. HIV-infected mothers should not breast-feed their infants because of the risk of transmitting the HIV infection or Agenerase Solution.

Possible side effects of Agenerase Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea/loose stools; headache; nausea; numbness or tingling around the mouth and in the hands and feet; rash; shift of body fat to stomach and upper back; stomach pain; taste disorders; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in mood, emotions, or behavior; clumsiness; depression; excessive thirst or hunger; fast heartbeat; fast, shallow breathing; fever, chills, or sore throat; increased or decreased urination; muscle pain or cramping; muscle stiffness; red, swollen, or blistered skin; seizures; severe muscle pain or cramping; stomach discomfort; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Agenerase Solution:

Store Agenerase Solution at room temperature, at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Agenerase Solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Agenerase Solution, please talk with your doctor, pharmacist, or other health care provider.
  • Agenerase Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Agenerase Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition
Copyright © 2007 Wolters Kluwer Health, Inc.

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