Description
Tipranavir is used in combination with ritonavir (Norvir®) to treat an infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have received HIV treatment in the past.
Tipranavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease from occurring. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tipranavir in children younger than 2 years of age or weighing less than 36 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tipranavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tipranavir.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfuzosin
- Amiodarone
- Astemizole
- Bepridil
- Cisapride
- Colchicine
- Dihydroergotamine
- Ergonovine
- Ergotamine
- Flecainide
- Grazoprevir
- Levoketoconazole
- Lomitapide
- Lovastatin
- Lurasidone
- Mavacamten
- Methylergonovine
- Midazolam
- Nirmatrelvir
- Pazopanib
- Pimozide
- Propafenone
- Quinidine
- Rifampin
- Sildenafil
- Simvastatin
- St John's Wort
- Terfenadine
- Tolvaptan
- Triazolam
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afatinib
- Amphetamine
- Amprenavir
- Apalutamide
- Artemether
- Atazanavir
- Atidarsagene Autotemcel
- Atorvastatin
- Avacopan
- Azathioprine
- Benzphetamine
- Berotralstat
- Betrixaban
- Boceprevir
- Bosentan
- Brentuximab Vedotin
- Cabazitaxel
- Cabotegravir
- Carbamazepine
- Ceritinib
- Cilostazol
- Clomipramine
- Cobicistat
- Codeine
- Conivaptan
- Cyclophosphamide
- Dabigatran Etexilate
- Dabrafenib
- Darunavir
- Delamanid
- Dextroamphetamine
- Dihydrocodeine
- Dolutegravir
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Drospirenone
- Duvelisib
- Eliglustat
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abacavir
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Bupropion
- Calcium Carbonate
- Clarithromycin
- Conjugated Estrogens
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Enfuvirtide
- Esterified Estrogens
- Estradiol
- Estriol
- Estrone
- Estropipate
- Ethinyl Estradiol
- Magaldrate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- Omeprazole
- Rosuvastatin
- Tenofovir Disoproxil Fumarate
- Zidovudine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diabetes or
- Hemophilia (a bleeding problem) or
- Hyperglycemia (high blood sugar) or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Liver disease (eg, hepatitis B or C)—Use with caution. May make these conditions worse.
- Liver disease, moderate or severe—Should not be used in patients with this condition.
- Sulfa allergy, known or suspected—Use with caution. May cause side effects to be worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine. If you stop taking this medicine, or do not take it as prescribed, you may spread HIV to others.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Talk to your doctor if you have any questions.
Tipranavir is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.
Take this medicine with food.
Swallow the capsule whole. Do not open or chew it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For treatment of HIV infection:
- For oral dosage forms (capsules):
- Adults and children 2 years of age and older weighing 36 kilograms (kg) or more—500 milligrams (mg) (two capsules) with 200 mg of ritonavir (Norvir®) 2 times a day.
- Children younger than 2 years of age or weighing less than 36 kg—Use and dose must be determined by your doctor.
- For oral dosage forms (capsules):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the capsules in the refrigerator until you are ready to open the bottle. Once you have opened the medicine bottle, you may store it at room temperature, away from heat, light, or moisture. The medicine is good for up to 60 days after you open the bottle. Throw away any unused capsules after 60 days and get a new bottle of medicine. .
Precautions
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), amiodarone (Cordarone®, Pacenone®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Methergine®, Migranal®), flecainide (Tambocor®), lovastatin (Altocor®, Mevacor®), lurasidone (Latuda®), midazolam (Versed®) pimozide (Orap®), propafenone (Rythmol®), quinidine (Cardioquin®, Quinaglute Dura®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), or triazolam (Halcion®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.
This medicine may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, a diaphragm, or contraceptive foam or jelly.
This medicine may cause bleeding problems, including intracranial hemorrhage (bleeding in the brain). Check with your doctor right away if you have confusion, headache, sudden, severe, nausea and vomiting, and weakness.
Check with your doctor right away if you or your child have pain in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.
It is important to practice safe sex, even if your partner also has HIV. Use a latex condom or other barrier method.
Do not re-use or share needles with anyone. This can increase the risk of spreading HIV and other diseases (eg, hepatitis C).
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, increased sensitivity of skin to sunlight, itching, redness or discoloration of the skin, rash with flat lesions or small raised lesions on the skin, severe sunburn, or skin rash.
This medicine may increase the risk of bleeding in patients with hemophilia (a bleeding disorder). Talk with your doctor about this risk.
This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Bleeding gums
- chest tightness
- confusion
- cough producing mucus
- coughing up blood
- difficulty with breathing or swallowing
- dizziness
- fever
- general feeling of tiredness or weakness
- headache
- increased menstrual flow or vaginal bleeding
- loss of appetite
- nausea or vomiting
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- red or black, tarry, or light-colored stools
- red or dark brown urine
- sudden severe weakness
- unusual bleeding
- upper right abdominal or stomach pain
- yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
Less common
- Cough
- discouragement
- fat redistribution
- feeling sad or empty
- irritability
- lack of appetite
- lack or loss of strength
- loss of interest or pleasure
- rash
- stomach pain
- trouble concentrating
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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