Tipranavir must be given with ritonavir to work effectively. When these two drugs are combined, there have been rare (sometimes fatal) cases of severe liver problems. Your doctor will monitor you closely and perform simple blood tests while you use this medication, especially if you also have infections that affect the liver (chronic hepatitis B or hepatitis C).
Patients being treated with tipranavir and ritonavir may rarely have a serious (sometimes fatal) bleeding problem in the brain (intracranial hemorrhage). This effect may be due to other drugs you are taking or conditions you may have, so do not stop taking tipranavir and ritonavir without consulting your doctor.
Seek immediate medical attention if you develop severe stomach/abdominal pain, unusual tiredness, loss of appetite, dark urine, yellowing of skin or eyes, unusual bleeding or bruising, or mental/mood changes.Who should not take Aptivus?
This drug must be used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.
Tipranavir belongs to a class of drugs known as protease inhibitors. It must be given with ritonavir, another protease inhibitor, to increase ("boost") the levels of tipranavir. This helps tipranavir work better.
Tipranavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
Read the Patient Information Leaflet provided by your pharmacist before you start using tipranavir 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 food, usually twice daily or as directed by your doctor. If you are using the capsule form of this medication, swallow whole. Do not crush or chew. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Tipranavir must be taken at the same times as ritonavir, another protease inhibitor.
Dosage is based on your medical condition and response to therapy. For children, dosage is also based on weight and body size.
It is very important to continue taking this medication (and other anti-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. Remember to use it at the same time(s) each day. Do not skip any doses.
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 (develop resistance), or worsen side effects.
See also Warning and Drug Interactions sections.
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.
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. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Tell your doctor immediately if any of these unlikely but serious side effects occur: depression, increased thirst, change in the amount of urine.
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.
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.
Tipranavir can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop a rash. Taking estrogen (in birth control or hormone therapy) may increase your risk of developing this rash.
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 tipranavir, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially 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).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This drug may infrequently make your blood sugar rise, an effect that can cause or worsen diabetes. High blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar such as unusual increased thirst/urination. If you already have diabetes, check your blood sugar regularly, and tell your doctor if you notice unusually high blood sugar levels.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This medication should be used only when clearly needed during pregnancy. 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: 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).
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting tipranavir.
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 atazanavir, certain anti-seizure medicines including carbamazepine/phenytoin, azole antifungals including itraconazole/ketoconazole, macrolide antibiotics including erythromycin).
Tipranavir can both speed up and slow down the removal of other drugs from your body, thereby affecting how they work. These affected drugs include (not a complete list): clarithromycin, colchicine, fluticasone, omeprazole, salmeterol, temsirolimus, valproic acid, trazodone, calcium channel blockers such as felodipine, drugs that suppress the immune system such as cyclosporine/sirolimus/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. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.
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.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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.
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.
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.
Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.
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