Sporanox

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 Sporanox 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 Sporanox 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause spots or redness of the skin; it may cause nausea and vomiting; it could cause water retention and swelling; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

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.

Do not take itraconazole if you:

• are allergic to itraconazole or any ingredients of the medication
• are allergic to other "azole" antifungals such as ketoconazole
• are taking the following medications: including dofetilide, Pimozide, quinidine, Lovastatin, Simvastatin, Triazolam, midazolam (when taken by mouth), ergot alkaloids (such as Dihydroergotamine, ergonovine, ergotamine), Eletriptan, and nisoldipine
  • asunaprevir (boosted)
  • Disopyramide
  • Domperidone
  • Dronedarone
  • Eplerenone
  • ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine)
  • Irinotecan
  • Lomitapide
  • lovastatin
  • Lurasidone
  • Methadone
  • Naloxegol
  • pimozide
  • quinidine
  • simvastatin
  • Ticagrelor
  • triazolam
• 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.

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) [jock itch], tinea pedis [Athlete's Foot], pityriasis versicolor).

There may be an interaction between itraconazole and any of the following:

• Abiraterone
• Aliskiren
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• Amiodarone
• 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)
• Apixaban
• Aprepitant
• Aripiprazole
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Alprazolam, Chlordiazepoxide, Clonazepam, Clorazepate, Diazepam, Flurazepam, midazolam)
• Bicalutamide
• birth control pills
• Bosentan
• Buprenorphine
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, verapamil)
• Carvedilol
• chloroquine
• Colchicine
• conivaptan
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• nasal corticosteroids (e.g., budesonide, fluticasone)
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• dabigatran
• Dantrolene
• Dapsone
• Degarelix
• didanosine
• Digoxin
• disopyramide
• dofetilide
• domperidone
• dronedarone
• Edoxaban
• eplerenone
• ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Flecainide
• Flutamide
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Guanfacine
• H2-receptor antagonists (e.g., Cimetidine, Famotidine, Nizatidine, ranitidine)
• Hepatitis C antivirals (e.g., asunaprevir, daclatasvir, grazoprevirsimeprevir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• isoniazid
• Ivabradine
• lidocaine
• Loperamide
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• methadone
• Metronidazole
• mifepristone
• Mirtazapine
• Modafinil
• Montelukast
• Nadolol
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• oxycodone
• pentamidine
• Phenobarbital
• phosphodiesterase-5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Prasugrel
• praziquantel
• procainamide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• proton pump inhibitors (e.g., omeprazole, Esomeprazole, Lansoprazole)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Repaglinide
• rifabutin
• rifampin
• rifapentine
• rilpivirine
• Rivaroxaban
• Romidepsin
• St. John's wort
• saccharomyces boulardii
• salmeterol
• seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, ondansetron, Palonosetron)
• Sirolimus
• Solifenacin
• Sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, lovastatin, simvastatin)
• sulcrafate
• Tacrolimus
• Tamoxifen
• Tetrabenazine
• Tetracycline
• Theophylline
• ticagrelor
• Ticlopidine
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Trimethoprim
• "triptan" migraine medications (e.g., eletriptan, Sumatriptan)
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Ulipristal
• Venlafaxine
• Warfarin
• Zolpidem
• Zopiclone

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:

• 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.

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 Sporanox. 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.

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 Sporanox.

Abnormal heart rhythms: Sporanox 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:

• 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

If you have heart disease and abnormal heart rhythms, or people are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, 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.

Effects on ability to drive and use machines: Itraconazole may cause dizziness, hearing or vision changes, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Sporanox.

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 Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, and whether any special monitoring is needed.

Kidney function: Decreased kidney function may affect how well Sporanox works for you. If you have kidney problems, discuss with your doctor how Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, 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 Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Sporanox.

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 Sporanox, contact your doctor immediately.

Breast-feeding: Sporanox 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 Sporanox should only be used if the benefits outweigh the risks.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication was prescribed for a specific period of time. Take it for the entire time prescribed in order to achieve the medication's full benefit, even if you begin to feel better sooner. The capsule of this medication should not be opened, crushed or chewed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication is more effective if taken with food. Always take it with a meal or a snack. Avoid consuming alcohol or alcohol-containing products while taking this medication.