ITRACONAZOLE- itraconazole capsule
Torrent Pharmaceuticals Limited
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PATIENT INFORMATION
Itraconazole (it″ ra kon′ a zole) Capsules USP |
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Read this Patient Information that comes with itraconazole capsules before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. | ||||||||
What is the most important information I should know about itraconazole capsules? Itraconazole capsules can cause serious side effects, including: | ||||||||
1. Heart failure. Do not take itraconazole capsules if you have had heart failure, including congestive heart failure. Stop taking itraconazole capsules and call your healthcare provider right away if you have any of these symptoms of congestive heart failure: |
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● | shortness of breath | ● coughing up white or pink mucus (phlegm) | ||||||
● | swelling of your feet, ankles or legs | ● fast heartbeat | ||||||
● | sudden weight gain | ● waking up at night more than normal for you | ||||||
● | increased tiredness | |||||||
2. Heart problems and other serious medical problems. Serious medical problems that affect the heart and other parts of your body can happen if you take itraconazole capsules with certain other medicines. Do not take itraconazole capsules if you also take the following medicines: | ||||||||
● | methadone | ● | irinotecan | ● | naloxegol | |||
● | disopyramide | ● | lurasidone | ● | lomitapide | |||
● | dofetilide | ● | oral midazolam | ● | lovastatin | |||
● | dronedarone | ● | pimozide | ● | simvastatin | |||
● | quinidine | ● | triazolam | ● | avanafil | |||
● | isavuconazole | ● | felodipine | ● | ticagrelor | |||
● | ergot alkaloids (such as dihydroergotamine, | ● | nisoldipine | ● | venetoclax(see below) | |||
ergometrine ergonovine) | ● | ivabradine | ● | finerenone | ||||
● | ergotamine | ● | ranolazine | ● | voclosporin | |||
● | methylergometrine | ● | eplerenone | |||||
● | (methylergonovine) | ● | cisapride | |||||
Do not take itraconazole with venetoclax for chronic lymphocytic leukemia/small lymphocytic lymphoma when you first start treatment with venetoclax or with increasing doses of venetoclax. | ||||||||
This is not a complete list of medicines that can interact with itraconazole capsules. Itraconazole capsules may affect the way other medicines work, and other medicines may affect how itraconazole capsules work. You can ask your pharmacist for a list of medicines that interact with itraconazole capsules. | ||||||||
Before you start taking itraconazole capsules, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start any new medicine, ask your healthcare provider or pharmacist if it is safe to take it with itraconazole capsules. |
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3. Liver problems. Itraconazole capsules can cause serious liver problems which may be severe and lead to death. Stop taking itraconazole capsules and call your healthcare provider right away if you have any of these symptoms of liver problems: | ||||||||
● | tiredness | ● your skin or the white part of your eyes turn yellow (jaundice) | ||||||
● | loss of appetite for several days or longer | ● light-colored stools (bowel movement) | ||||||
● | nausea or vomiting | |||||||
● | dark or "tea-colored" urine | |||||||
For more information about side effects, see "What are the possible side effects of itraconazole capsules?" | ||||||||
What are itraconazole capsules?
● Itraconazole capsules are a prescription medicine used to treat the following fungal infections of the toenails, fingernails and other parts of the body: blastomycosis, histoplasmosis, aspergillosis, and onychomycosis. ● It is not known if itraconazole capsules are safe and effective in children. |
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Do not take itraconazole capsules if you:
● have or have had heart failure, including congestive heart failure. ● take certain medicines. See "What is the most important information I should know about itraconazole capsules?" ● are pregnant or plan to become pregnant. Itraconazole capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking itraconazole capsules. Females who are able to become pregnant must use effective forms of birth control during treatment and for 2 months after stopping treatment with itraconazole capsules. ● are allergic to itraconazole or any of the ingredients in itraconazole capsules. See the end of this Patient Information leaflet for a complete list of ingredients in itraconazole capsules. |
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Before taking itraconazole capsules, tell your healthcare provider about all of your medical conditions, including if you:
● have heart problems. ● have liver problems. ● have kidney problems. ● have a weakened immune system (immunocompromised). ● have lung problems including cystic fibrosis. ● are breastfeeding or plan to breastfeed. Itraconazole can pass into your breast milk. You and your healthcare provider should decide if you will take itraconazole capsules or breastfeed. Taking itraconazole capsules with certain medicines may affect each other. Taking itraconazole capsules with other medicines can cause serious side effects. |
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How should I take itraconazole capsules?
● You should not take itraconazole oral solution instead of itraconazole capsules, because they will not work the same way. |
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What should I avoid while taking itraconazole capsules?
Itraconazole capsules can cause dizziness and vision problems. Do not drive or operate machinery until you know how itraconazole capsules affect you. |
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What are the possible side effects of itraconazole capsules?
Additional possible side effects include upset stomach, constipation, fever, inflammation of the pancreas, menstrual disorder, erectile dysfunction, dizziness, muscle pain, painful joints, unpleasant taste, or hair loss. These are not all the possible side effects of itraconazole capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store itraconazole capsules?
• Store itraconazole capsules at room temperature between 59°F and 77°F (15°C and 25°C). • Keep itraconazole capsules dry and away from light. Keep itraconazole capsules and all medicines out of the reach of children. |
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General information about the safe and effective use of itraconazole capsules.
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What are the ingredients in itraconazole capsules?
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For more information or call Torrent Pharma Inc. at 1-800-912-9561. |
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Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. 8094593 Revised: November 2023 |
This Patient Information has been approved by the U.S. Food and Drug Administration