Fosamprenavir

Fosamprenavir is used for:

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Treating HIV infection in some patients when used in combination with certain other medicines.

Fosamprenavir is an HIV protease inhibitor. It works by slowing the growth of HIV, the virus that causes AIDS.

Do NOT use Fosamprenavir if:

• you are allergic to any ingredient in Fosamprenavir or to amprenavir
• you are taking amprenavir, cisapride, conivaptan, delavirdine, erythromycin, an ergot alkaloid (eg, ergotamine), an H₁ antagonist (eg, astemizole, terfenadine), pimozide, rifampin, or St. John's wort
• you are taking a hormonal contraceptive (eg, birth control pills), certain benzodiazepines (eg, midazolam, triazolam), or certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin)
• you are taking flecainide or propafenone along with ritonavir

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

Before using Fosamprenavir :

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

• if you are pregnant, 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, a severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
• if you have liver problems, hepatitis, or a history of abnormal liver function tests
• if you have kidney problems, diabetes, bleeding problems (eg, hemophilia), high blood cholesterol or lipid levels, or a skin rash

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

• Cisapride, ergot alkaloids (eg, ergotamine), erythromycin, H₁ antagonists (eg, astemizole, terfenadine), or pimozide because serious side effects such as seizures, blood vessel problems, or heart problems (eg, irregular heartbeat) may occur
• Flecainide or propafenone along with ritonavir because serious heart problems (eg, irregular heartbeat) may occur
• Benzodiazepines (eg, midazolam, triazolam) because serious side effects such as increased or prolonged sedation or breathing problems may occur
• Hormonal contraceptives (eg, birth control pills), especially if taken along with ritonavir, because their effectiveness may be decreased and liver problems may occur
• Amprenavir because it may increase the risk of Fosamprenavir 's side effects
• Rifampin or St. John's wort because they may decrease Fosamprenavir 's effectiveness
• HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), conivaptan, or ranolazine because the risk of their side effects may be increased by Fosamprenavir
• Delavirdine because its effectiveness may be decreased by Fosamprenavir
• Many prescription and nonprescription medicines (eg, used for cancer, infections, asthma, immune suppression, inflammation, aches and pains, high blood pressure, high cholesterol, heart problems, irregular heartbeat, angina, blood clotting problems, mood or mental problems, sinus problems, stomach problems or indigestion, erectile dysfunction, seizures, sleeping problems, urinary problems, HIV infection), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Fosamprenavir , increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosamprenavir 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 Fosamprenavir :

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

• An extra patient leaflet is available with Fosamprenavir . Talk to your pharmacist if you have questions about this information.
• Take Fosamprenavir by mouth with or without food.
• Eating grapefruit or drinking grapefruit juice while you are taking Fosamprenavir may increase the amount of Fosamprenavir in your blood. This may increase your risk for serious side effects. Talk with your doctor before including grapefruit juice in your diet.
• If you take an aluminum- or magnesium-containing antacid, ask your doctor or pharmacist how to take it with Fosamprenavir .
• Do not change your dose or stop taking Fosamprenavir without talking with your doctor first. Continue to take Fosamprenavir even if you feel well. Do not miss any doses.
• Taking Fosamprenavir at the same time(s) each day will help you remember to take it. It is important to not miss any doses of Fosamprenavir .
• If you miss a dose of Fosamprenavir , take it as soon as you remember. If you miss a dose of Fosamprenavir by more than 4 hours, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Fosamprenavir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Fosamprenavir does not stop the spread of HIV to others through blood or sexual contact. Use barrier forms of contraception (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Fosamprenavir , even for a short period of time. If you do, the virus may grow resistent to the medicine and become harder to treat.
• Fosamprenavir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice signs or symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Fosamprenavir .
• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Fosamprenavir . The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• Diabetes patients - Fosamprenavir may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before adjusting the dose of your diabetes medicine.
• Fosamprenavir may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Fosamprenavir . To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Lab tests, including liver function, cholesterol or triglyceride levels, white blood cell count, and blood sugar levels, may be performed while you use Fosamprenavir . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Fosamprenavir in CHILDREN; they may be more sensitive to its effects, especially vomiting.
• Fosamprenavir should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosamprenavir while you are pregnant. It is not known if Fosamprenavir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Fosamprenavir to the baby.

Possible side effects of Fosamprenavir :

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:

Changes in body fat distribution; diarrhea; headache; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); loss of appetite; signs of infection (eg, fever, chills, sore throat); swollen, reddened, or blistered skin; unusual increase in thirst or urination; weight loss; yellowing of 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 / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately.

Store Fosamprenavir at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep the container tightly closed. Do not use after the expiration date. Keep Fosamprenavir out of the reach of children and away from pets.

General information:

• If you have any questions about Fosamprenavir , please talk with your doctor, pharmacist, or other health care provider.
• Fosamprenavir 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 Fosamprenavir . 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.

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