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Black Box Warning
WARNING
See full prescribing information for complete Boxed Warning.
* Congestive Heart Failure, Cardiac Effects and Drug Interactions
Overview
Itraconazole is a {{{drugClass}}} that is FDA approved for the treatment of blastomycosis, histoplasmosis, histoplasmosis in HIV-infected patients, aspergillosis, onychomycosis of the toenail and onychomycosis of the fingernail. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, vomiting, diarrhea, abdominal pain, anorexia, fatigue, rash, headache and dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:
Blastomycosis, pulmonary and extrapulmonary
Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.
Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients:
Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and
Onychomycosis of the fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
Description of Clinical Studies
Blastomycosis
Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases.
Histoplasmosis
Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases.
Histoplasmosis in HIV-Infected Patients
Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse.
Aspergillosis
Analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 mg to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy.
Onychomycosis of the Toenail
Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive).
Onychomycosis of the Fingernail
Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course (pulse) of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week pulse of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.
Dosing Information
Itraconazole capsules should be taken with a full meal to ensure maximal absorption. Itraconazole capsules must be swallowed whole.
Itraconazole capsules is a different preparation than itraconazole oral solution and should not be used interchangeably.
Treatment of Blastomycosis and Histoplasmosis
The recommended dose is 200 mg once daily (2 capsules). If there is no obvious improvement, or there is evidence of progressive fungal disease, the dose should be increased in 100-mg increments to a maximum of 400 mg daily. Doses above 200 mg/day should be given in two divided doses.
Treatment of Aspergillosis
A daily dose of 200 mg to 400 mg is recommended.
Treatment in Life-Threatening Situations
In life-threatening situations, a loading dose should be used.
Although clinical studies did not provide for a loading dose, it is recommended, based on pharmacokinetic data, that a loading dose of 200 mg (2 capsules) three times daily (600 mg/day) be given for the first 3 days of treatment.
Treatment should be continued for a minimum of three months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.
Itraconazole capsules and itraconazole oral solution should not be used interchangeably. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.
Treatment of Onychomycosis
Toenails with or without fingernail involvement: The recommended dose is 200 mg (2 capsules) once daily for 12 consecutive weeks.
Treatment of Onychomycosis
Fingernails only: The recommended dosing regimen is 2 treatment pulses, each consisting of 200 mg (2 capsules) b.i.d. (400 mg/day) for 1 week. The pulses are separated by a 3-week period without itraconazole.
Use in Patients with Renal Impairment
Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population (see CLINICAL PHARMACOLOGY, SPECIAL POPULATIONS and PRECAUTIONS).
Use in Patients with Hepatic Impairment
Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Itraconazole in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Itraconazole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Itraconazole in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Itraconazole in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Itraconazole in pediatric patients.
Contraindications
Congestive Heart Failure
Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
Drug Interactions
Coadministration of a number of CYP3A4 substrates are contraindicated with itraconazole. Plasma concentrations increase for the following drugs: methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin and, in subjects with renal or hepatic impairment, colchicine. This increase in drug concentrations caused by coadministration with itraconazole may increase or prolong both the pharmacologic effect and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia.
Itraconazole should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy.
Itraconazole is contraindicated for patients who have shown hypersensitivity to itraconazole. There is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used when prescribing itraconazole to patients with hypersensitivity to other azoles.
Warnings
WARNING
See full prescribing information for complete Boxed Warning.
* Congestive Heart Failure, Cardiac Effects and Drug Interactions
Hepatic Effects
Cardiac Dysrhythmias=
Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using drugs such as cisapride, pimozide, methadone, or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors. Concomitant administration of these drugs with itraconazole is contraindicated.
Cardiac Disease
Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. Itraconazole capsules should not be used for other indications in patients with evidence of ventricular dysfunction unless the benefit clearly outweighs the risk.
For patients with risk factors for congestive heart failure, physicians should carefully review the risks and benefits of itraconazole therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of CHF, should be treated with caution, and should be monitored for signs and symptoms of CHF during treatment. If signs or symptoms of CHF appear during administration of itraconazole capsules, discontinue administration.
Itraconazole has been shown to have a negative inotropic effect. When itraconazole was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented. In a healthy volunteer study of itraconazole intravenous infusion, transient, asymptomatic decreases in left ventricular ejection fraction were observed using gated SPECT imaging; these resolved before the next infusion, 12 hours later.
Itraconazole has been associated with reports of congestive heart failure. In post-marketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.
Calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole. In addition, itraconazole can inhibit the metabolism of calcium channel blockers. Therefore, caution should be used when co-administering itraconazole and calcium channel blockers due to an increased risk of CHF. Concomitant administration of itraconazole and felodipine or nisoldipine is contraindicated.
Cases of CHF, peripheral edema, and pulmonary edema have been reported in the post-marketing period among patients being treated for onychomycosis and/or systemic fungal infections.
Interaction Potential
Itraconazole has a potential for clinically important drug interactions. Coadministration of specific drugs with itraconazole may result in changes in efficacy of itraconazole and/or the coadministered drug, life-threatening effects and/or sudden death. Drugs that are contraindicated, not recommended or recommended for use with caution in combination with itraconazole are listed in PRECAUTIONS, DRUG INTERACTIONS.
Interchangeability
Itraconazole capsules and itraconazole oral solution should not be used interchangeably. This is because drug exposure is greater with the Oral Solution than with the Capsules when the same dose of drug is given. In addition, the topical effects of mucosal exposure may be different between the two formulations. Only the Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.
PRECAUTIONS
General
Itraconazole capsules should be administered after a full meal.
Under fasted conditions, itraconazole absorption was decreased in the presence of decreased gastric acidity. The absorption of itraconazole may be decreased with the concomitant administration of antacids or gastric acid secretion suppressors. Studies conducted under fasted conditions demonstrated that administration with 8 ounces of a non-diet cola beverage resulted in increased absorption of itraconazole in AIDS patients with relative or absolute achlorhydria. This increase relative to the effects of a full meal is unknown.
Hepatotoxicity
Rare cases of serious hepatotoxicity have been observed with itraconazole treatment, including some cases within the first week. It is recommended that liver function monitoring be considered in all patients receiving itraconazole. Treatment should be stopped immediately and liver function testing should be conducted in patients who develop signs and symptoms suggestive of liver dysfunction.
Neuropathy
If neuropathy occurs that may be attributable to itraconazole capsules, the treatment should be discontinued.
Hearing Loss
Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole. Several of these reports included concurrent administration of quinidine which is contraindicated. The hearing loss usually resolves when treatment is stopped, but can persist in some patients.
Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of itraconazole use should be reassessed.
Adverse Events in the Treatment of Systemic Fungal Infections
Adverse event data were derived from 602 patients treated for systemic fungal disease in U.S. clinical trials who were immunocompromised or receiving multiple concomitant medications. Treatment was discontinued in 10.5% of patients due to adverse events. The median duration before discontinuation of therapy was 81 days (range: 2 to 776 days). The table lists adverse events reported by at least 1% of patients.
TABLE
Adverse events infrequently reported in all studies included constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.
Adverse Events Reported in Toenail Onychomycosis Clinical Trials
Patients in these trials were on a continuous dosing regimen of 200 mg once daily for 12 consecutive weeks.
The following adverse events led to temporary or permanent discontinuation of therapy.
TABLE
The following adverse events occurred with an incidence of greater than or equal to 1% (N=112): headache: 10%; rhinitis: 9%; upper respiratory tract infection: 8%; sinusitis, injury: 7%; diarrhea, dyspepsia, flatulence, abdominal pain, dizziness, rash: 4%; cystitis, urinary tract infection, liver function abnormality, myalgia, nausea: 3%; appetite increased, constipation, gastritis, gastroenteritis, pharyngitis, asthenia, fever, pain, tremor, herpes zoster, abnormal dreaming: 2%.
Adverse Events Reported in Fingernail Onychomycosis Clinical Trials
Patients in these trials were on a pulse regimen consisting of two 1-week treatment periods of 200 mg twice daily, separated by a 3-week period without drug.
The following adverse events led to temporary or permanent discontinuation of therapy.
TABLE
The following adverse events occurred with an incidence of greater than or equal to 1% (N=37): headache: 8%; pruritus, nausea, rhinitis: 5%; rash, bursitis, anxiety, depression, constipation, abdominal pain, dyspepsia, ulcerative stomatitis, gingivitis, hypertriglyceridemia, sinusitis, fatigue, malaise, pain, injury: 3%.
Postmarketing Experience
Adverse drug reactions that have been first identified during post-marketing experience with itraconazole (all formulations) are listed in the table below. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
TABLE
There is limited information on the use of itraconazole during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with itraconazole has not been established.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Itraconazole in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Itraconazole during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Itraconazole with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Itraconazole with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Itraconazole with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Itraconazole with respect to specific gender populations.
Race
There is no FDA guidance on the use of Itraconazole with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Itraconazole in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Itraconazole in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Itraconazole in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Itraconazole in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Itraconazole in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Itraconazole in the drug label.
Overdosage
Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Activated charcoal may be given if considered appropriate. In general, adverse events reported with overdose have been consistent with adverse drug reactions already listed in this package insert for itraconazole.
Pharmacology
There is limited information regarding Itraconazole Pharmacology in the drug label.
There is limited information regarding Pharmacodynamics of Itraconazole in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Itraconazole in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Itraconazole in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Itraconazole in the drug label.
How Supplied
Itraconazole Capsules, for oral administration, are available as:
100 mg: Aqua blue opaque cap, light blue clear body, imprinted “E 550” in black ink on cap and body, filled with white to off-white pellets and supplied as:
This summary contains important information about itraconazole (eye-trah-KON-ah-zole). This information is for patients who have been prescribed itraconazole capsules to treat fungal nail infections. If your doctor prescribed itraconazole for medical problems other than fungal nail infections, ask your doctor if there is any information in this summary that does not apply to you. Read this information carefully each time you start to use itraconazole. This information does not take the place of discussion between you and your doctor. Only your doctor can decide if itraconazole is the right treatment for you. If you do not understand some of this information or have any questions, talk with your doctor or pharmacist.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ITRACONAZOLE?
Itraconazole is used to treat fungal nail infections. However, itraconazole is not for everyone. Do not take itraconazole for fungal nail infections if you have had heart failure, including congestive heart failure. You should not take itraconazole if you are taking certain medicines that could lead to serious or life-threatening medical problems. (See "WHO SHOULD NOT TAKE ITRACONAZOLE CAPSULES?" below.)
If you have had heart, lung, liver, kidney or other serious health problems, ask your doctor if it is safe for you to take itraconazole.
WHAT HAPPENS IF I HAVE A FUNGAL NAIL INFECTION?
Anyone can have a fungal nail infection, but it is usually found in adults. When a fungus infects the tip or sides of a nail, the infected part of the nail may turn yellow or brown. If not treated, the fungus may spread under the nail towards the cuticle. If the fungus spreads, more of the nail may change color, may become thick or brittle, and the tip of the nail may become raised. In some patients, this can cause pain and discomfort.
WHAT IS ITRACONAZOLE?
Itraconazole is a prescription medicine used to treat fungal infections of the toenails and fingernails. It is also used to treat some types of fungal infections in other areas of your body. We do not know if itraconazole works in children with fungal nail infections or if it is safe for children to take.
Itraconazole comes in the form of capsules and liquid (oral solution). The capsule and liquid forms work differently, so you should not use one in place of the other. This Patient Information discusses only the capsule form of itraconazole. You will get these capsules in a medicine bottle or a 7-Day Treatment Pack. The 7-Day Treatment Pack contains 28 capsules for treatment of your fungal nail infection.
Itraconazole goes into your bloodstream and travels to the source of the infection underneath the nail so that it can fight the infection there. Improved nails may not be obvious for several months after the treatment period is finished because it usually takes about 6 months to grow a new fingernail and 12 months to grow a new toenail.
WHO SHOULD NOT TAKE ITRACONAZOLE?
Itraconazole is not for everyone. Your doctor will decide if itraconazole is the right treatment for you. Some patients should not take itraconazole because they may have certain health problems or may be taking certain medicines that could lead to serious or life-threatening medical problems.
Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking, including dietary supplements and herbal remedies. Also tell your doctor about any other medical conditions you have had, especially heart, lung, liver or kidney conditions; or if you have had an allergic reaction to itraconazole or any other antifungal medicines.
Never take itraconazole if you:
have had heart failure, including congestive heart failure.
are taking any of the medicines listed below. Dangerous or even life-threatening abnormal heartbeats could result:
quinidine (such as Cardioquin ®, Quinaglute ®, Quinidex ®)
dofetilide (such as Tikosyn™)
cisapride (such as Propulsid ®)
pimozide (such as Orap ®)
methadone (such as Dolophine ®)
disopyramide (such as Norpace ®)
dronedarone (such as Multaq ®)
ranolazine (such as Ranexa ®)
are taking any of the following medicines:
lovastatin (such as Mevacor ®, Advicor ®, Altocor™)
colchicine (such as Colcrys™) [if you also have pre-existing kidney or liver impairment]
have ever had an allergic reaction to itraconazole.
Taking itraconazole with certain other medicines could lead to serious or life-threatening medical problems. For example, taking fentanyl, a strong opioid narcotic pain medicine, with itraconazole could cause serious side effects, including trouble breathing, that may be life-threatening. Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking. Your doctor will decide if itraconazole is the right treatment for you.
WHAT SHOULD I KNOW ABOUT ITRACONAZOLE AND PREGNANCY OR BREAST FEEDING?
Never take itraconazole if you have a fungal nail infection and are pregnant or planning to become pregnant within 2 months after you have finished your treatment.
If you are able to become pregnant, you should use effective birth control during itraconazole treatment and for 2 months after finishing treatment. Ask your doctor about effective types of birth control.
If you are breast-feeding, talk with your doctor about whether you should take itraconazole.
HOW SHOULD I TAKE ITRACONAZOLE?
Always take itraconazole capsules during or right after a full meal.
Your doctor will decide the right dose for you. Depending on your infection, you will take itraconazole once a day for 12 weeks, or twice a day for 1 week in a “pulse” dosing schedule. You will receive either a bottle of capsules or a 7-Day Treatment Pack. Do not skip any doses. Be sure to finish all your itraconazole as prescribed by your doctor.
If you have ever had liver problems, your doctor should do a blood test to check your condition. If you haven't had liver problems, your doctor may recommend blood tests to check the condition of your liver because patients taking itraconazole can develop liver problems.
Itraconazole can sometimes cause dizziness or blurred/double vision. If you have these symptoms, do not drive or use machines.
If you forget to take or miss doses of itraconazole, ask your doctor what you should do with the missed doses.
THE ITRACONAZOLE CAPSULES 7-DAY TREATMENT PACK
If you use the 7-Day Treatment Pack, you will take itraconazole for 1 week and then take no itraconazole for the next 3 weeks before repeating the 1-week treatment. This is called “pulse dosing.” The Itraconazole Capsules 7-Day Treatment Pack contains enough medicine for one "pulse" (1 week of treatment).
The Itraconazole Capsules 7-Day Treatment Pack comes with special instructions. It contains 7 pouches-one for each day of treatment. Inside each pouch is a card containing 4 capsules. Looking at the back of the card, fold it back along the dashed line and peel away the backing so that you can remove 2 capsules.
Take 2 capsules in the morning and 2 capsules in the evening. This means you will take 4 capsules a day for 7 days. At the end of 7 days, you will have taken all of the capsules in the 7-Day Treatment Pack.
After you finish the 7-Day Treatment Pack, do not take any itraconazole for the next 3 weeks. Even though you are not taking any capsules during this time, itraconazole keeps working inside your nails to help fight the fungal infection.
You will need more than one “pulse” to treat your fungal nail infection. When your doctor prescribes another pulse treatment, be sure to get your refill before the end of week 4.
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WHAT ARE THE POSSIBLE SIDE EFFECTS OF ITRACONAZOLE?
The most common side effects include: headache, and digestive system problems (such as nausea, and abdominal pain).
Stop Itraconazole and call your doctor or get medical assistance right away if you have a severe allergic reaction. Symptoms of an allergic reaction may include skin rash, itching, hives, shortness of breath or difficulty breathing, and/or swelling of the face. Very rarely, an over sensitivity to sunlight, a tingling sensation in the limbs or a severe skin disorder can occur. If any of these symptoms occur, stop taking itraconazole and contact your doctor.
Stop Itraconazole and call your doctor right away if you develop shortness of breath; have unusual swelling of your feet, ankles or legs; suddenly gain weight; are unusually tired; cough up white or pink phlegm; have unusual fast heartbeats; or begin to wake up at night. In rare cases, patients taking itraconazole could develop serious heart problems, and these could be warning signs of heart failure.
Stop Itraconazole and call your doctor right away if you become unusually tired; lose your appetite; or develop nausea, abdominal pain, or vomiting, a yellow color to your skin or eyes, or dark colored urine or pale stools (bowel movements). In rare cases, patients taking itraconazole could develop serious liver problems and these could be warning signs.
Stop Itraconazole and call your doctor right away if you experience any hearing loss symptoms. In very rare cases, patients taking itraconazole have reported temporary or permanent hearing loss.
Call your doctor right away if you develop tingling or numbness in your extremities (hands or feet), if your vision gets blurry or you see double, if you hear a ringing in your ears, if you lose the ability to control your urine or urinate much more than usual.
Additional possible side effects include upset stomach, vomiting, 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 side effects of itraconazole. Your doctor or pharmacist can give you a more complete list.
WHAT SHOULD I DO IF I TAKE AN OVERDOSE OF ITRACONAZOLE?
If you think you took too much itraconazole, call your doctor or local poison control center, or go to the nearest hospital emergency room right away.
HOW SHOULD I STORE ITRACONAZOLE?
Keep all medicines, including itraconazole, out of the reach of children.
Store itraconazole capsules and the 7-Day Treatment Pack at room temperature in a dry place away from light.
GENERAL ADVICE ABOUT ITRACONAZOLE
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use itraconazole for a condition for which it was not prescribed. Do not give itraconazole to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about itraconazole. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about itraconazole that is written for health professionals.
This patient information has been approved by the U.S. Food and Drug Administration.
For Patient Information, please visit WWW.US.SANDOZ.COM or call 1-800-507-2130.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sandoz Inc.
Princeton, NJ 08540
OS7722, Rev. 08/14
MF0550REV08/14
MG #35963
and
OS8359, Rev. 08/14
MF0550REV08/14
Precautions with Alcohol
Alcohol-Itraconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Itraconazole Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Itraconazole Look-Alike Drug Names in the drug label.
