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All about: Lexiva

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Generic Name: Fosamprenavir Tablets (FOS-am-PREN-a-veer)
Brand Name: Lexiva

Lexiva is used for:

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

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

Do NOT use Lexiva if:

  • you are allergic to any ingredient in Lexiva 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 Lexiva :

Some medical conditions may interact with Lexiva . 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 Lexiva . 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 increase 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 Lexiva 's side effects
  • Rifampin or St. John's Wort because they may decrease Lexiva 's effectiveness
  • Certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), conivaptan, or randolazine because the risk of their side effects may be increased by Lexiva
  • Delavirdine because its effectiveness may be decreased by Lexiva
  • Many prescription and nonprescription medicines (eg, used for cancer, infections, 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 this medicine, 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 Lexiva 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 Lexiva :

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

  • An extra patient leaflet is available with Lexiva . Talk to your pharmacist if you have questions about this information.
  • Take Lexiva by mouth with or without food.
  • Eating grapefruit or drinking grapefruit juice while you are taking Lexiva may increase the amount of Lexiva 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 Lexiva .
  • Do not change your dose or stop taking Lexiva without talking with your doctor first. Continue to take Lexiva even if you feel well. Do not miss any doses.
  • Take Lexiva at the same time(s) each day to help you remember to take it. It is important to not miss any doses of Lexiva .
  • If you miss a dose of Lexiva , take it as soon as you remember. If you miss a dose of Lexiva by more than 4 hours, skip the missed dose and return to your normal dosing schedule. Do not take 2 doses at once.

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

Important safety information:

  • Lexiva is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • This medicine 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 pharmacy as soon as you can. Do not stop taking Lexiva , even for a short period of time. If you do, the virus may grow resistent to the medicine and become harder to treat.
  • Lexiva 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 Lexiva .
  • 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 Lexiva . The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Diabetes patients - Lexiva may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Lexiva 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 Lexiva . 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 Lexiva . 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 Lexiva in CHILDREN; they may be more sensitive to its effects, especially vomiting.
  • Lexiva 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 Lexiva while you are pregnant. It is not known if Lexiva is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Lexiva to the baby.

Possible side effects of Lexiva :

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.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); 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/findyour.htm), or emergency room immediately.

Proper storage of Lexiva :

Store Lexiva 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 Lexiva out of the reach of children and away from pets.

General information:

  • If you have any questions about Lexiva , please talk with your doctor, pharmacist, or other health care provider.
  • Lexiva 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 Lexiva . 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 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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