Amprenavir is known to interact with many different types of medicines, in some cases causing severe (sometimes fatal) reactions. Consult your doctor or pharmacist about which medications should not be taken with amprenavir. (See also Drug Interactions section.)

This drug, used in combination with at least 2 other medications, helps to control your HIV infection, thereby improving your quality of life. It also lowers your risk of getting HIV complications (e.g., new infections, cancer). Amprenavir belongs to a class of drugs known as protease inhibitors.

Amprenavir is not a cure for HIV, and it does not prevent the spread of HIV to others through sexual contact or blood contamination (e.g., sharing used needles).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent HIV infection after contact with the virus.

Read the Patient Information Leaflet provided by your pharmacist before you start taking amprenavir and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth with or without a meal (low-fat) or up to 2 hours after a meal, usually 2 times daily or as directed by your doctor.

The dosage is based on your weight, liver function, medical condition, other medications, and response to therapy.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

This medication contains vitamin E to help preserve the amprenavir. Do not take any other vitamin E supplements unless directed to do so by your doctor because too much vitamin E can cause health problems.

If you are taking antacids (including didanosine dispersible tablets /solution), take amprenavir at least 1 hour before or after the antacid.

The capsule and liquid forms of amprenavir are not equal in strength. Do not switch forms without consulting your doctor or pharmacist.

See also Warning section.

Diarrhea, nausea, vomiting, heartburn, stomach pain, gas, loss of appetite, headache, tiredness, strange taste in the mouth, or tingling/numbness of hands/feet/mouth area may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin, decreased sexual interest, mental/mood changes (e.g., depression, anxiety), increasing tiredness, increased urination (especially at night), increased thirst, fruity breath odor.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe tiredness, fainting, pale lips/nails/skin, fast heartbeat, fast breathing.

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

If you are taking HIV medications for the first time, you may experience symptoms of an old infection. This may happen as your immune system begins to work better. Contact your doctor immediately if you notice any of the following symptoms: new cough, trouble breathing, fever, new vision problems, new headaches, new skin problems.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking amprenavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (e.g., hepatitis B, hepatitis C), alcohol use, diabetes, hemophilia, high blood fats (high cholesterol/triglycerides).

If you have diabetes, this product may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication should be used only when clearly needed during pregnancy. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Amprenavir may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: amiodarone, bepridil, delavirdine, etravirine, quinidine, tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine), cisapride, pimozide, dihydroergotamine, ergonovine, ergotamine, methylergonovine, St John's wort, midazolam, triazolam, simvastatin, lovastatin, rifampin, ranolazine, artemether/lumefantrine.

Avoid using hormonal birth control (e.g., pills, patch, ring) while taking this medication. Using hormonal birth control while also taking this medication can make both drugs less effective. Consult your doctor or pharmacist for more details and for information about other birth control methods. To reduce the risk of spreading HIV to others, always use effective barrier protection during all sexual activity. (See also Notes section.)

If amprenavir is taken with ritonavir, the following medications should also not be used: flecainide, propafenone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: garlic capsules, sildenafil, tadalafil, vardenafil, trazodone, ketoconazole, itraconazole, saquinavir, lopinavir/ritonavir, indinavir, nelfinavir, didanosine (dispersible tablets/solution), nevirapine, efavirenz, carbamazepine, phenobarbital, phenytoin, rifabutin, fluticasone, atorvastatin, certain calcium channel blockers (e.g., nifedipine, felodipine, nicardipine), warfarin, ranitidine, dexamethasone, certain drugs that weaken the immune system (cyclosporine, tacrolimus, sirolimus), temsirolimus, alprazolam, diazepam, flurazepam, clonazepam, clorazepate, estazolam, methadone.

If any of these medications are taken with amprenavir, your doctor may change your dose of amprenavir or the other drug(s), or your doctor may monitor you specially. Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

To reduce the risk of spreading HIV to others, always use effective barrier protections (e.g., latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver tests, triglycerides/cholesterol, viral load, t-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical and laboratory appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Refrigerate the U.S. product between 36-46 degrees F (2-8 degrees C) away from light and moisture. Amprenavir may also be stored at room temperature below 77 degrees F (25 degrees C), but in this case it should be used within 30 days. Do not store in the bathroom.

Store the Canadian product between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised September 2009 Copyright(c) 2009 First DataBank, Inc.