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Amprenavir Safety Reports

Amprenavir is used in combination with other antiretroviral medications to treat human immunodeficiency virus (HIV). Amprenavir belongs to a class of drugs called protease (pro' tee ace) inhibitors, which slow the spread of HIV infection in the body.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?   Return to top

Amprenavir comes as a capsule and liquid to take by mouth. It is usually taken twice a day. Amprenavir may be taken with or without food. However, avoid taking amprenavir with high-fat foods or high-fat meals. The amount of drug in amprenavir capsules is not the same as the amount in amprenavir liquid. Do not switch between amprenavir capsules and amprenavir liquid unless your doctor tells you how many amprenavir capsules or how much amprenavir liquid you should take. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amprenavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Amprenavir is not a cure and may not decrease the number of HIV-related illnesses. Amprenavir does not prevent the spread of HIV to other people. Continue to take amprenavir even if you feel well. Do not stop taking amprenavir without talking to your doctor.

What special precautions should I follow?   Return to top

Before taking amprenavir,

• tell your doctor and pharmacist if you are allergic to amprenavir, sulfa drugs, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking in addition to those listed in the IMPORTANT WARNING section, especially alprazolam (Xanax); amiodarone (Cordarone); antacids; anticoagulants ('blood thinners') such as warfarin (Coumadin); astemizole (Hismanal);atorvastatin (Lipitor); bepridil (Vascor); betamethasone (Celestone); bepridil (Vascor); birth control pills; carbamazepine (Carbatrol, Epitol, Tegretol); cerivastatin (Baycol); cimetidine (Tagamet); cisapride (Propulsid); clorazepate (Tranxene); clozapine (Clozaril); cortisone acetate (Cortone); dapsone (Avlosulfon); delavirdine (Rescriptor); dexamethasone (Decadron, Hexadrol, others); diazepam (Valium); didanosine (Videx); dihydroergotamine (D.H.E. 45, Migranal); diltiazem (Cardizem, Dilacor); efavirenz (Sustiva); ergonovine (Ergotrate); ergotamine (Cafergot, Ercaf, others); erythromycin (E.E.S., E-Mycin, PCE, others); flurazepam (Dalmane); hydrocortisone (Cortef, Cortenema, Hydrocortone); itraconazole (Sporanox); lidocaine (Xylocaine, LidoPen Auto-Injector, others); loratadine (Claritin); lovastatin (Mevacor); medications for depression such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); medications for diabetes; methylprednisolone (Depo-Medrol, others); midazolam (Versed); nevirapine (Viramune); nicardipine (Cardene); nifedipine (Adalat, Procardia); nimodipine (Nimotop); phenobarbital (Barbita); phenytoin (Dilantin, Diphenylan Sodium); pimozide (Orap); prednisolone (Delta-Cortef, Prelone); prednisone (Orasone, Deltasone, others); quinidine (Quinaglute, Cardioquin, Quinidex); rifabutin (Mycobutin); rifampin (Rifadin, Rifamate, Rifater, Rimactane); ritonavir (Norvir); sildenafil (Viagra); simvastatin (Zocor); steroid medications such as estrogen or progesterone; terfenadine (Seldane); triamcinolone (Aristocort, Kenacort); triazolam (Halcion); vitamin E and any other vitamins.
• take amprenavir 1 hour before or 1 hour after you take antacids or didanosine (Videx).
• tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort or products containing St. John's wort.
• if you are taking birth control pills, you should talk to your doctor about using another form of birth control because amprenavir may decrease the effectiveness of your birth control pills.
• tell your doctor if you have or have ever had liver or kidney disease, diabetes, or hemophilia.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Once you begin taking amprenavir, you should not plan to become pregnant or breast-feed. If you become pregnant while taking amprenavir capsules, call your doctor.
• if you are taking amprenavir liquid, you should avoid drinking alcohol.
• you should be aware that your body fat may increase or move to different areas of your body, such as your breasts and your upper back.

What special dietary instructions should I follow?   Return to top

Do not take vitamin E supplements if you are taking amprenavir. Amprenavir capsules and solutions contain vitamin E and you do not need to take additional vitamin E to meet the daily requirement for this vitamin.

What should I do if I forget a dose?   Return to top

If you miss a dose by less than 4 hours, take the missed dose as soon as you remember it. If you miss a dose by more than 4 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

Amprenavir may cause hyperglycemia (high blood sugar). Call your doctor immediately if you have any of the following symptoms:

• extreme thirst
• frequent urination
• extreme hunger
• weakness
• blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

• dry mouth
• upset stomach and vomiting
• shortness of breath
• breath that smells fruity
• decreased consciousness

Amprenavir may cause other side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• diarrhea or loose stools
• stomach pain
• change in taste
• tingling sensation around your mouth

If you experience any of the following symptoms, call your doctor immediately:

• rash
• seizures (if you are taking the liquid)
• confusion (if you are taking the liquid)
• rapid heart rate (if you are taking the liquid)

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?   Return to top

It is important that you do not run out of your supply of amprenavir or other antiviral medications because the amount of HIV in your blood may increase if you stop taking them. When your supply of amprenavir is low, make sure you contact your doctor or pharmacist for a refill.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to amprenavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.