TIPRANAVIR

When tipranavir and ritonavir are combined, there have been rare (sometimes fatal) cases of severe liver problems and bleeding problem in the brain (intracranial hemorrhage).

Notify your doctor or pharmacist promptly If any of these effects persist or worsen:

• diarrhea
• nausea
• drowsiness
• dizziness
• headache
• vomiting

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• depression
• increased thirst
• change in the amount of urine

Seek immediate medical attention if any of these rare but serious side effects occur:

• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• severe stomach/abdominal pain
• unusual tiredness
• loss of appetite
• dark urine
• yellowing of skin or eyes
• unusual bleeding or bruising, or mental/mood changes

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).

A very serious allergic reaction to this drug is unlikely.

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

Precautions:

• Allergic reaction to this medication
• Patients with medical history of:
  • Diabetes
  • heart problems (coronary artery disease, heart attack)
  • blood or bleeding disorders (e.g., hemophilia)
  • other conditions causing an increased risk of bleeding (e.g., injury, surgery)
  • high blood fat levels (cholesterol/triglyceride)
  • other viral infections (chronic hepatitis B or hepatitis C)
  • liver disease (including abnormal liver function tests)
• May make you dizzy or drowsy
• Can cause or worsen diabetes.
• May make you more sensitive to the sun
• Used only when clearly needed during pregnancy
• Do not breast-feed

Consult your doctor regarding the precautions mentioned above.

Interactions:

This drug should not be used with the following medications because very serious interactions may occur:

• cisapride
• pimozide
• certain heart rhythm drugs (amiodarone, bepridil, flecainide, propafenone, quinidine)
• benzodiazepines (e.g., midazolam, triazolam)
• certain cholesterol-lowering drugs (atorvastatin, lovastatin, simvastatin)
• eletriptan
• eplerenone
• ergot-containing drugs (e.g., ergotamine)
• ranolazine
• certain drugs affecting liver enzymes that remove tipranavir from your body (rifampin, St. John’s wort)

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

• antiplatelet drugs (e.g., clopidogrel)
• artemether
• “blood thinners” (anticoagulants such as warfarin, heparins)
• NSAIDs (e.g., ibuprofen, naproxen, sulindac, indomethacin)
• disulfiram
• estrogens (e.g., ethinyl estradiol)
• garlic supplements
• vitamin E
• lumefantrine
• metronidazole
• drugs affecting liver enzymes that remove tipranavir from your body (such as certain anti-seizure medicines including carbamazepine/phenytoin, macrolide antibiotics including erythromycin)

Tipranavir can affect how other drugs work. These affected drugs include (not a complete list):

• clarithromycin
• colchicine
• fluticasone
• omeprazole
• salmeterol
• valproic acid
• trazodone
• calcium channel blockers such as felodipine
• drugs that suppress the immune system such as cyclosporine/tacrolimus
• certain narcotic pain medications such as meperidine/methadone
• other HIV medications (such as etravirine, other protease inhibitors including fosamprenavir/lopinavir/saquinavir)
• other rifamycins including rifabutin
• drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil)
• antidepressants such as fluoxetine/sertraline/desipramine

Aspirin can increase the risk of bleeding when used with this medication.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring.

This document does not contain all possible interactions. Tipranavir is always given with ritonavir which also has many drug 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.

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver function tests, HIV RNA levels, blood sugar, blood counts, blood cholesterol/triglyceride levels) 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.

Missed Dose

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.

Storage

If you are using the capsules, refrigerate the unopened bottles between 36-46 degrees F (2-8 degrees C). Once opened, the capsules may be stored at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.

If you are using the liquid form, store it at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not refrigerate or freeze the liquid.

For all forms of this drug, properly discard any unused medication 60 days after first opening the bottle. To help you remember when to discard unused medication, write the opening date on the bottle. 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.

Brands:

There are no brands containing this molecule.