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DIN (Drug Identification Number)
02047454 SPORANOX CAPSULES 100MG CAPSULE
How does this medication work? What will it do for me?
Itraconazole belongs to the family of medications called antifungals. It is used to treat certain types of fungal infections, both internally (inside the body) and externally (skin and nails). It works by preventing the fungus from growing.
Itraconazole solution is used specifically for treatment of fungus (candidiasis) occurring in the mouth or esophagus (the tube leading from the throat to the opening of the stomach) in people infected with HIV or in people whose natural defences against infections are depleted.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each pink and blue capsule, imprinted in white with "JANSSEN" on the cap and "SPORANOX" over "100" on the body, contains 100 mg of itraconazole in a pellet formulation. Nonmedicinal ingredients: D&C Red No. 22, D&C Red No. 28, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, hydroxypropyl methylcellulose, polyethylene glycol, sugar spheres (NF), and titanium dioxide.
How should I use this medication?
Capsules: The recommended adult dose of itraconazole capsules ranges from 100 mg once daily after a full meal to 200 mg twice daily after meals, depending on the condition being treated. The length of treatment also depends on the condition being treated. Itraconazole capsules should be taken right after a full meal. Itraconazole capsules must be swallowed whole.
Solution: The dose of oral solution depends on the condition being treated. The usual recommended dose ranges from 100 mg to 200 mg daily. Swish the solution in the mouth and swallow. Do not rinse after swallowing so that the medication can stay in contact with the affected area as long as possible. The oral solution is best taken without food.
Use the dosing cup supplied with itraconazole solution to measure doses accurately.
Grapefruit juice may reduce the effectiveness of itraconazole.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children. Oral solution that is left over 3 months after opening the bottle should be safely discarded.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
- are allergic to itraconazole or any ingredients of the medication
- are allergic to other "azole" antifungals such as ketoconazole
- are taking certain medications, including dofetilide, pimozide, quinidine, lovastatin, simvastatin, triazolam, midazolam (when taken by mouth), ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine), eletriptan, and nisoldipine
- have a history of heart failure (including congestive heart failure) – itraconazole may be used to treat other more serious types of fungal infections in people who have or have had heart failure when the benefit of treatment clearly outweighs the risk.
Do not take itraconazole if you:
Women who are pregnant or planning to become pregnant should not take itraconazole to treat onychomycosis (fungal nail infections) or dermatomycoses (fungal skin infections such as tinea corporis (ringworm), tinea cruris (jock itch), tinea pedis (athlete's foot), pityriasis versicolor).
What side effects are possible with this medication?
- abdominal pain
- increased sensitivity to sunlight
- skin rash
- unpleasant taste in the mouth
- blurred vision
- fever and chills
- joint pain
- loss of ability to control urine or urinating much more than usual
- “pins and needles” feeling
- reduced sense of touch
- ringing in the ears
- signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, skin rash and itching)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of a severe skin reaction such as reddening, blistering, peeling, or loosening of skin and mucous membranes
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
- are female
- are older than 65 years of age
- have a family history of sudden cardiac death
- have a history of heart disease or abnormal heart rhythms
- have a slow heart rate
- have congenital prolongation of the QT interval
- have diabetes
- have had a stroke
- have low potassium, magnesium, or calcium levels
- have nutritional deficiencies
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., cisapride, methadone, pimozide, or quinidine) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with itraconazole. You are more at risk for this type of abnormal heart rhythm and its complications if you:
If you have heart disease and abnormal heart rhythms, or people are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Capsules and solution: Itraconazole capsules and oral solution should not be used interchangeably. When the same dose of medication is given, the exposure to the itraconazole is greater with the oral solution than with the capsules.
Decreased stomach acidity: Less itraconazole is absorbed into the body when stomach acidity is decreased. For people also taking antacids (e.g., aluminum hydroxide), these should be taken at least 2 hours after itraconazole. In people with achlorhydria (decreased stomach acidity), such as certain AIDS patients or people on acid secretion suppressors (e.g., H2-antagonists such as ranitidine or proton pump inhibitors such as omeprazole), it is advisable to take itraconazole with a cola beverage.
Heart failure: Itraconazole may cause symptoms of heart failure to become worse. If you have risk factors for heart failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Itraconazole may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
For treatment with itraconazole longer than 30 days, your doctor will order lab tests to monitor liver function. Although serious liver reactions have been rare, contact your doctor if you notice signs of liver problems such as unusual fatigue, loss of appetite, nausea or vomiting, yellowing of the skin or eyes, dark urine, or pale stools.
Pregnancy: Women who may become pregnant must use an effective form of birth control during therapy and for 2 menstrual cycles (2 months) after stopping therapy with itraconazole. Itraconazole should not be used during pregnancy unless the benefit outweighs the risks. It should not be used for the treatment of onychomycoses (fungal nail infections) or dermatomycoses (fungal skin infections) in women who are pregnant or planning to become pregnant. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking itraconazole, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The efficacy and safety of using itraconazole have not been established for children.
Seniors: Information regarding the safety and effectiveness of itraconazole when used by seniors is limited. The risk of side effects is greater for people over 65 years of age, so they should this medication should only be used if the benefits outweigh the risks.
What other drugs could interact with this medication?
- alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
- anti-cancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, trastuzumab, vincristine)
- anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- benzodiazepines (e.g., alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, flurazepam, midazolam)
- birth control pills
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
- nasal corticosteroids (e.g., budesonide, fluticasone)
- oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- fusidic acid
- “gliptin” diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
- grapefruit juice
- H2-receptor antagonists (e.g., cimetidine, famotidine, nizatidine, ranitidine)
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
- phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
- progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
- proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- St. John's wort
- seizure medications (e.g., clobazam, ethosuximide, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
- serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron, palonosetron)
- "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
- tricyclic antidepressasnts (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- "triptan" migraine medications (e.g., eletriptan, sumatriptan)
- tyrosine kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
There may be an interaction between itraconazole and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sporanox-Capsules
All material © 1996-2019 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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