Sunday 5 August 2012

itraconazole


Generic Name: itraconazole (IT ra KON a zole)

Brand Names: Sporanox, Sporanox PulsePak


What is itraconazole?

Itraconazole is an antifungal medication.


Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.


Itraconazole may also be used for purposes not listed in this medication guide.


What is the most important information I should know about itraconazole?


Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal), if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment. There are many other drugs that can cause serious or life threatening medical problems if you take them together with itraconazole. This includes cisapride (Propulsid), dihydroergotamine (D.H.E. 45, Migranal), dofetilide (Tikosyn), ergonovine (Ergotrate), ergotamine (Ergomar), lovastatin (Advicor, Altocor, Altoprev, Mevacor), methylergonovine (Methergine), midazolam (Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quin-G), simvastatin (Zocor, Simcor, Vytorin), and triazolam (Halcion).

Before taking itraconazole, tell your doctor if you have heart disease, a history of stroke, a heart rhythm disorder, kidney or liver disease, a breathing disorder, cystic fibrosis, or a history of "Long QT syndrome."


Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Itraconazole will not treat a viral infection such as the common cold or flu.

What should I discuss with my healthcare provider before taking itraconazole?


Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal), if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment. There are many other drugs that can cause serious or life threatening medical problems if you take them together with itraconazole. The following drugs should not be used while you are taking itraconazole:

  • cisapride (Propulsid);




  • dofetilide (Tikosyn);




  • lovastatin (Advicor, Altocor, Altoprev, Mevacor) or simvastatin (Zocor, Simcor, Vytorin);




  • midazolam (Versed) or triazolam (Halcion);




  • nisoldipine (Sular);




  • pimozide (Orap);




  • quinidine (Quin-G); and




  • ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Ercaf, Migergot), or methylergonovine (Methergine).



To make sure you can safely take itraconazole, tell your doctor if you have any of these other conditions:



  • heart disease, a heart rhythm disorder, circulation problems, or a history of stroke;




  • chronic obstructive pulmonary disease (COPD) or other breathing disorder;




  • kidney disease;




  • liver disease;




  • cystic fibrosis; or




  • a personal or family history of "Long QT syndrome."




FDA pregnancy category C. It is not known whether itraconazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Itraconazole passes into breast milk and can harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take itraconazole?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


The itraconazole tablet should be taken after a full meal. Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medication at the pharmacy and ask the pharmacist if you have any questions. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Itraconazole will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.


Store at room temperature away from moisture, heat, and light.

See also: Itraconazole dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking itraconazole?


Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) within 1 hour before or 2 hours after you take itraconazole. These medications can make it harder for your body to absorb itraconazole.


Itraconazole side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • fever;




  • feeling short of breath, even with mild exertion;




  • swelling, rapid weight gain;




  • problems with hearing;




  • numbness or tingly feeling;




  • pain or burning when you urinate;




  • nausea, pain in your upper stomach, itching, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or




  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.



Less serious side effects may include:



  • diarrhea, constipation, mild stomach pain;




  • mild itching or skin rash;




  • headache, dizziness; or




  • runny nose or other cold symptoms.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Itraconazole Dosing Information


Usual Adult Dose for Blastomycosis:

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose may be increased in 100 mg increments to a maximum of 400 mg/day

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided. Some clinicians recommend therapy for at least 12 months for disseminated or chronic pulmonary histoplasmosis and 6 to 12 months for blastomycosis.

Usual Adult Dose for Histoplasmosis:

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose may be increased in 100 mg increments to a maximum of 400 mg/day

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided. Some clinicians recommend therapy for at least 12 months for disseminated or chronic pulmonary histoplasmosis and 6 to 12 months for blastomycosis.

Usual Adult Dose for Aspergillosis -- Aspergilloma:

Capsules: 200 to 400 mg orally per day in one or two divided doses

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

Usual Adult Dose for Oral Thrush:

Oral solution:
Oropharyngeal candidiasis: 200 mg orally once a day for 1 to 2 weeks

Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets: 100 mg orally twice a day

Clinical response will be seen in 2 to 4 weeks in patients responding to therapy. Patients may be expected to relapse shortly after discontinuing therapy.

Usual Adult Dose for Esophageal Candidiasis:

Oral solution: 100 mg orally once a day for a minimum of 3 weeks
Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg/day may be used.

Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Usual Adult Dose for Onychomycosis -- Toenail:

Capsules (with or without fingernail involvement) or tablets: 200 mg orally once a day for 12 consecutive weeks

Usual Adult Dose for Onychomycosis -- Fingernail:

Fingernails only:
Capsules: 200 mg orally twice a day for 1 week; the dosing should be repeated after 3 weeks without itraconazole for a total of 2 treatment pulses

Usual Adult Dose for Candida Urinary Tract Infection:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for 1 to 2 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Candidemia:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for 1 to 2 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Coccidioidomycosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for at least 6 months and until tests indicate fungal infection has subsided.

Usual Adult Dose for Paracoccidioidomycosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for at least 6 months and until tests indicate fungal infection has subsided.

Usual Adult Dose for Dermatophytosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for at least 4 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Sporotrichosis:

Capsules:
Cutaneous or lymphonodular infection: 100 to 200 mg orally once a day
Osteoarticular or pulmonary infection: 200 mg to 300 mg orally 2 times a day

Usual Adult Dose for Cryptococcosis:

Capsules: 200 to 400 mg orally each day
The 400 mg/day dose is recommended for more severe infection and infection with central nervous system involvement in an HIV-infected patient.

Usual Adult Dose for Tinea Versicolor:

Capsules: 200 mg orally 2 times a day

Usual Adult Dose for Vaginal Candidiasis:

Capsules: 200 mg orally 2 times a day for 1 day

Usual Pediatric Dose for Histoplasmosis:

HIV-infected infants and children:
Prophylaxis for first episode: 2 to 5 mg/kg orally every 12 to 24 hours
Prophylaxis for recurrence: 2 to 5 mg/kg orally every 12 to 48 hours

Usual Pediatric Dose for Cryptococcosis:

HIV-infected infants and children:
Prophylaxis for first episode and recurrence: 2 to 5 mg/kg orally every 12 to 24 hours

Usual Pediatric Dose for Tinea Capitis:

Continuous regimen:
Trichophyton tonsurans and Trichophyton violaceum (endothrix) species: 5 mg/kg/day orally for 2 to 4 weeks
Microsporum canis (ectothrix) species: 5 mg/kg/day orally for 4 to 6 weeks

Pulse regimen:
Capsules:
T tonsurans, T violaceum (endothrix), and M canis (ectothrix) species: 5 mg/kg/day orally for 1 week followed by a 3-week period off of treatment

Patient is evaluated on week 4 from the start of therapy for clinical response. If evidence of tinea capitis remains, additional pulse therapies may be required up to a maximum of 3 pulses.


What other drugs will affect itraconazole?


Many drugs can interact with itraconazole. Below is just a partial list. Tell your doctor if you are using:



  • a blood thinner such as warfarin (Coumadin);




  • cancer medications;




  • cholesterol medications such as atorvastatin (Lipitor);




  • cyclosporine (Gengraf, Sandimmune, Neoral);




  • diabetes medication you take by mouth;




  • digoxin (digitalis, Lanoxin);




  • disopyramide (Norpace);




  • fentanyl (Actiq, Duragesic);




  • isoniazid (for treating tuberculosis);




  • rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), or rifapentine (Priftin);




  • sirolimus (Rapamune) or tacrolimus (Prograf);




  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);




  • an antifungal medication such as clotrimazole (Mycelex Troche), ketoconazole (Nizoral), or voriconazole (Vfend);




  • an antidepressant such as nefazodone, paroxetine (Paxil), or sertraline (Zoloft);




  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton);




  • heart or blood pressure medications such as amlodipine (Norvasc), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase, Fortovase), or ritonavir (Norvir, Kaletra);




  • a sedative such as alprazolam (Xanax), diazepam (Valium); or




  • seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or phenytoin (Dilantin), or primidone (Mysoline).




This list is not complete and there are many other drugs that can interact with itraconazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More itraconazole resources


  • Itraconazole Side Effects (in more detail)
  • Itraconazole Dosage
  • Itraconazole Use in Pregnancy & Breastfeeding
  • Drug Images
  • Itraconazole Drug Interactions
  • Itraconazole Support Group
  • 11 Reviews for Itraconazole - Add your own review/rating


  • itraconazole Advanced Consumer (Micromedex) - Includes Dosage Information

  • Itraconazole Professional Patient Advice (Wolters Kluwer)

  • Itraconazole Prescribing Information (FDA)

  • Itraconazole MedFacts Consumer Leaflet (Wolters Kluwer)

  • Itraconazole Monograph (AHFS DI)

  • Sporanox Consumer Overview

  • Sporanox Prescribing Information (FDA)

  • Sporanox PulsePak MedFacts Consumer Leaflet (Wolters Kluwer)



Compare itraconazole with other medications


  • Aspergillosis, Aspergilloma
  • Blastomycosis
  • Candida Infections, Systemic
  • Candida Urinary Tract Infection
  • Coccidioidomycosis
  • Cryptococcosis
  • Dermatophytosis
  • Esophageal Candidiasis
  • Febrile Neutropenia
  • Histoplasmosis
  • Onychomycosis, Fingernail
  • Onychomycosis, Toenail
  • Oral Thrush
  • Paracoccidioidomycosis
  • Sporotrichosis
  • Tinea Capitis
  • Tinea Versicolor
  • Vaginal Yeast Infection


Where can I get more information?


  • Your pharmacist can provide more information about itraconazole.

See also: itraconazole side effects (in more detail)


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