Tipranavir

Tipranavir is an antiviral medicine used to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). Tipranavir is not a cure for HIV or AIDS.

Tipranavir is taken along with another drug called ritonavir.

Tipranavir may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tipranavir is taken together with ritonavir (Norvir). Use tipranavir and ritonavir regularly to get the most benefit.

Take your medicine with food if you are taking tipranavir with ritonavir tablets.

You may take your medicine with or without food if you are taking tipranavir with ritonavir capsules or liquid.

Swallow the tipranavir capsule whole. Do not open or chew it.

Measure tipranavir liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Tell your doctor if the child using tipranavir has any changes in height or weight. Tipranavir doses are based on body surface area (height and weight) in children, and any changes may affect your dose.

You will need frequent medical tests.

If you need surgery, tell the surgeon ahead of time that you are using tipranavir.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store an unopened bottle of tipranavir capsules in the refrigerator. Do not freeze. After opening the bottle, store the capsules at room temperature.

Store tipranavir liquid at room temperature away from moisture and heat. Do not store the liquid in the refrigerator.

Throw away any capsules or liquid you have not used within 60 days after you first opened the medicine bottle.

You should not use tipranavir if you have moderate to severe liver disease.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Some people taking tipranavir with ritonavir have developed serious medical issues, including liver damage and bleeding in the brain. Stop taking these medicines and get emergency medical help if you have: right-sided upper stomach pain, nausea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), unusual bleeding, sudden severe headache, or problems with speech or vision.

You should not use tipranavir if you are allergic to it, or if you have:

• moderate to severe liver disease.

Some medicines can cause unwanted or dangerous effects when used with tipranavir. Your doctor may change your treatment plan if you also use:

• alfuzosin;
• cisapride;
• lurasidone;
• pimozide;
• rifampin;
• sildenafil (Revatio for pulmonary arterial hypertension);
• St. John's wort;
• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine;
• heart medication--amiodarone, flecainide, propafenone, quinidine;
• a sedative--oral midazolam, triazolam; or
• "statin" cholesterol medicine--atorvastatin, lovastatin, simvastatin.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);
• diabetes;
• high cholesterol or triglycerides;
• a bleeding disorder such as hemophilia; or
• an allergy to sulfa drugs.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Tipranavir can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Tipranavir should not be given to a child younger than 2 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking tipranavir with ritonavir have experienced life-threatening medical issues, including liver damage and bleeding in the brain. Stop taking tipranavir and seek emergency medical help if you have:

• pain in the upper right side of your stomach, nausea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• unusual bleeding, sudden severe headache, problems with speech or vision.

Tipranavir may lead to serious side effects. Contact your doctor immediately if you have:

• severe skin rash, blistering, peeling, redness or sunburn;
• skin rash along with joint or muscle pain, fever, or tightness in your throat; or
• increased thirst, increased urination, hunger, dry mouth.

Tipranavir affects your immune system, which may result in certain side effects (even weeks or months after taking this medicine). Inform your doctor if you have:

• signs of a new infection—fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• difficulty speaking or swallowing, problems with balance or eye movement, weakness or a prickly sensation; or
• swelling in your neck or throat (enlarged thyroid), changes in your menstrual cycle, impotence.

Common side effects of tipranavir may include:

• nausea, vomiting, diarrhea, stomach pain;
• skin rash (especially in children);
• headache, fever, feeling tired; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for HIV Infection:

Tipranavir 500 mg plus ritonavir 200 mg orally twice a dayUse: In combination with ritonavir and other antiretrovirals, for the treatment of HIV-1 infection in therapy-experienced patients infected with HIV-1 strains resistant to more than 1 protease inhibitor

Usual Pediatric Dose for HIV Infection:

2 to 18 years:-Based on weight: Tipranavir 14 mg/kg plus ritonavir 6 mg/kg orally twice a day-Based on BSA: Tipranavir 375 mg/m2 plus ritonavir 150 mg/m2 orally twice a dayMaximum dose: Tipranavir 500 mg/dose plus ritonavir 200 mg/doseComments:-Special vigilance recommended during dose calculation, medication order transcription, dispensing information, and dosing instructions to reduce risk for medication errors, overdose, and underdose.-Pediatric dose should not exceed the usual adult dose.Use: In combination with ritonavir and other antiretrovirals, for the treatment of HIV-1 infection in therapy-experienced patients infected with HIV-1 strains resistant to more than 1 protease inhibitor

Take the medicine as soon as you can, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Get your prescription refilled before you completely run out of medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you also take didanosine, take it 2 hours before or after you take tipranavir.

Avoid taking vitamin E supplements if you are using the liquid form of tipranavir.

Using tipranavir will not prevent your disease from spreading. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Many drugs can influence tipranavir, and some drugs should not be taken together. Inform your doctor about all your current medications and any new medicine you begin or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are included here.