Itraconazole

Name: Itraconazole

What side effects can this medication cause?

Itraconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • constipation
  • gas or bloating
  • heartburn
  • unpleasant taste
  • sore or bleeding gums
  • headache
  • dizziness
  • sweating
  • muscle pain or weakness
  • joint pain
  • decreased sexual desire or ability
  • nervousness
  • depression
  • runny nose and other cold symptoms
  • fever
  • hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • blurred vision or double vision
  • ringing in the ears
  • inability to control urination or urinating more than usual

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, stop taking itraconazole and call your doctor immediately or get emergency medical treatment:

  • excessive tiredness
  • loss of appetite
  • nausea
  • stomach pain
  • vomiting
  • yellowing of the skin or eyes
  • dark urine
  • pale stools
  • feelings of numbness, tingling, pricking, burning, or creeping on the skin
  • hearing loss
  • increased sensitivity to light
  • severe skin disorder
  • hearing loss
  • rash
  • hives
  • itching
  • swelling of the face, throat, tongue, lips, eyes, hands, ankles, or lower legs
  • hoarseness
  • difficulty breathing or swallowing

One of the ingredients in itraconazole oral solution caused cancer in some types of laboratory animals. It is not known whether people who take itraconazole solution have an increased risk of developing cancer. Talk to your doctor about the risks of taking itraconazole solution.

Itraconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What Is Itraconazole?

Itraconazole is an antifungal medication that fights infections caused by fungus.

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.

You should not take this medicine if you have ever had congestive heart failure.

Many drugs can interact with itraconazole, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with itraconazole.

Life-threatening side effects may occur if you take itraconazole with cisapride, dihydroergotamine, disopyramide, dofetilide, dronedarone, eplerenone, ergonovine, ergotamine, felodipine, irinotecan, lurasidone, lovastatin, methadone, methylergonovine, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, or triazolam.

If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, solifenacin, or telithromycin.

You should not take itraconazole to treat a toenail or fingernail infection if you are pregnant or may become pregnant during treatment.

You should not take this medicine if you are allergic to itraconazole or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.

You should not take itraconazole to treat a toenail or fingernail infection if you are pregnant or may become pregnant during treatment.

Life-threatening side effects may occur if you take itraconazole with:

  • cisapride;
  • eplerenone;
  • irinotecan;
  • methadone;
  • ranolazine;
  • ticagrelor;
  • disopyramide, dofetilide, dronedarone, quinidine;
  • felodipine or nisoldipine;
  • lovastatin or simvastatin;
  • oral midazolam, triazolam;
  • lurasidone, pimozide; or
  • ergot medicines such as dihydroergotamine, ergonovine, ergotamine, or methylergonovine.

If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, solifenacin, or telithromycin.

To make sure itraconazole is safe for you, tell your doctor if you have:

  • heart disease, a heart rhythm disorder, circulation problems, or a history of stroke;
  • chronic obstructive pulmonary disease (COPD) or other breathing disorder;
  • kidney disease;
  • cirrhosis or other liver disease;
  • cystic fibrosis; or
  • a personal or family history of long QT syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Itraconazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

What is itraconazole?

Itraconazole is an antifungal medication that fights infections caused by fungus.

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 should I avoid while taking itraconazole?

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid taking antacids within 1 hour before or 2 hours after you take itraconazole. Some antacids can make it harder for your body to absorb itraconazole.

Cautions for Itraconazole

Contraindications

  • Hypersensitivity to itraconazole or any ingredient in the formulation.1 48

  • Concomitant use with certain drugs metabolized by CYP3A4 isoenzymes (e.g., cisapride, lovastatin, midazolam, pimozide, quinidine, dofetilide, simvastatin, triazolam).1 (See Specific Drugs under Interactions.)

Warnings/Precautions

Warnings

Hepatotoxicity

Serious hepatotoxicity, including liver failure and death, has occurred rarely and has been reported in patients with or without preexisting liver disease or a serious underlying medical condition.1 48 Some cases occurred within the first week of itraconazole therapy.48

Mild transient increases in serum liver enzyme concentrations may occur.1 16 17 19 28 36 Increased serum hepatic enzymes (greater than twice the ULN) that required temporary or permanent discontinuance of the drug has occurred in patients receiving itraconazole capsules for treatment of onychomycosis of the toenails (using a 12-week continuous dosing regimen).1

Should not be used in patients with increased serum hepatic enzymes, active liver disease, or a history of liver toxicity with other drugs unless the potential benefits exceed the risks.1 48

Monitor serum hepatic enzyme concentrations in any patient with preexisting hepatic impairment and in those who have experienced liver toxicity with other drugs.1 48 In addition, consider monitoring serum hepatic enzymes in all patients receiving itraconazole.1 48

Itraconazole should be discontinued immediately and the risks and benefits of continuing therapy with the drug reassessed if signs and symptoms consistent with liver disease develop.1 48

Cardiac Effects

CHF, peripheral edema, and pulmonary edema have been reported in immunocompromised or immunocompetent patients receiving itraconazole for treatment of systemic fungal infections and also have been reported in immunocompetent patients receiving oral itraconazole capsules for treatment of onychomycosis.1 48

Heart failure reported more frequently in those receiving itraconazole dosage of 400 mg daily, but has been reported in those receiving lower dosage.1 48

Manufacturer states itraconazole capsules should not be used for treatment of onychomycosis in patients with evidence of ventricular dysfunction, such as CHF or history of CHF, and should not be used for other indications in patients with evidence of ventricular dysfunction, unless benefits clearly outweigh risks.1 Discontinued itraconazole oral capsules in patients who develop CHF while receiving the drug.1

Manufacturer states itraconazole oral solution should not be used for treatment of systemic fungal infections in patients with evidence of ventricular dysfunction, such as CHF or history of CHF, except for treatment of life-threatening or other serious infections when benefits clearly outweigh risks.48 If CHF occurs during therapy with itraconazole oral solution, carefully monitor patient and evaluate therapeutic options (including possible discontinuance of the drug).48

Clinicians should carefully review the risks and benefits of itraconazole therapy in patients with risk factors for CHF (e.g., those with cardiac disease such as ischemic and valvular disease, clinically important pulmonary disease such as chronic obstructive pulmonary disease, or renal failure and other edematous disorders).1 48 If itraconazole is considered necessary in patients with risk factors for CHF, they should be informed of the signs and symptoms of CHF and carefully monitored during therapy.1 48

Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients receiving cisapride, pimozide, levomethadyl (no longer commercially available in the US), or quinidine concomitantly with itraconazole or other CYP3A4 inhibitors.1 48 (See Interactions.)

Warnings Related to Oral Solution

Safety and efficacy of itraconazole oral solution has been established only for treatment of oropharyngeal and esophageal candidiasis; the oral solution should not be used interchangeably with the capsules for treatment of other fungal infections.48

Oral solution not evaluated for treatment of oropharyngeal and/or esophageal candidiasis in severely neutropenic patients.48 Oral solution not recommended for initial treatment in patients at immediate risk of systemic candidiasis.48

Variable itraconazole concentrations reported in cystic fibrosis patients receiving the oral solution.48 If oral solution is used in cystic fibrosis patients and an adequate response is not obtained, consider using alternative therapy.48 (See Pediatric Use under Cautions.)

Oral solution contains hydroxypropyl-β-cyclodextrin (HP-β-CD) as an excipient.48 HP-β-CD has produced pancreatic adenocarcinomas in rat carcinogenicity studies, but similar effects were not observed in a mouse carcinogenicity study.48 The clinical relevance of this finding is not known.48

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis and Stevens-Johnson syndrome reported rarely.1 48

Cross-hypersensitivity

Although information concerning cross-sensitivity between itraconazole and other triazole or imidazole antifungals is not available, manufacturer states that itraconazole should be used with caution in individuals hypersensitive to other azoles.1

General Precautions

Neuropathy

Although a causal relationship has not been established, neuropathy (including peripheral neuropathy) has occurred rarely in patients receiving itraconazole.1 48

Discontinue itraconazole if neuropathy occurs that may be attributable to the drug.1

Otic Effects

Transient or permanent hearing loss reported in patients receiving itraconazole.1 48 In some reported cases, patient was also receiving quinidine, a drug that is contraindicated during itraconazole therapy.1 48 (See Specific Drugs under Interactions.)

Hearing loss usually resolves when itraconazole is discontinued, but persists in some patients.1 48

If hearing loss occurs, discontinue itraconazole.1 48

Superinfection

Overgrowth of nonsusceptible fungi may occur.1 These patients may require alternative antifungal therapy.1

Selection and Use of Antifungals for Onychomycosis

Prior to administration of itraconazole, appropriate nail specimens for microbiologic studies (e.g., potassium hydroxide [KOH] preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.1

When selecting an antifungal for treatment of onychomycosis, consider reported adverse effects and risk of serious effects, possibility of drug interactions, need for prolonged therapy, cost, and risk of relapse.132 133

Toenail infections generally require more prolonged antifungal therapy than fingernail infections.1 132 133

Specific Populations

Pregnancy

Category C.1 48

Although causal relationship not established, congenital abnormalities (skeletal, genitourinary tract, cardiovascular, ophthalmic) and chromosomal and multiple malformations have been reported during postmarketing experience when the drug was used in pregnant women.1 48

Do not use for treatment of onychomycosis in pregnant women or women contemplating pregnancy.1

Lactation

Distributed into human milk.1 48 Weigh expected benefits against potential risks to the infant.1 48

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 49

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 14 48

Has been recommended by IDSA and others for treatment of some fungal infections (e.g., blastomycosis, oropharyngeal candidiasis, coccidioidomycosis†, histoplasmosis, sporotrichosis†) in children†, including HIV-infected infants, children, and adolescents†.424 428 429 441

The manufacturer states that a limited number of patients 3–16 years of age with systemic nonmeningeal fungal infections have received itraconazole capsules in a dosage of 100 mg daily1 14 48 and a limited number of pediatric patients 6 months to 12 years of age requiring systemic antifungal therapy have received itraconazole oral solution in a dosage of 5 mg/kg once daily for 2 weeks without any unusual adverse effects.48

Data from a pharmacokinetic study evaluating itraconazole oral solution in patients with cystic fibrosis indicate that itraconazole concentrations are variable in such patients and trough concentrations attained in children <16 years of age are lower than those attained in patients 16–28 years of age.48 Consider using alternative therapy if the oral solution is used in cystic fibrosis patients and an adequate response is not obtained.48

Long-term effects of itraconazole therapy on bone growth in children not known.1 48 Data from rat studies indicate that itraconazole induces bone defects, including decreased bone plate activity, thinning of the zona compacta of large bones, and increased bone fragility.1 48 Bone toxicity observed in animals has not been reported to date in adults receiving itraconazole.1 48

Geriatric Use

Use caution in geriatric patients.1 48

Transient or permanent hearing loss reported in geriatric patients receiving itraconazole.1 48 In some reported cases, patient was also receiving quinidine, a drug that is contraindicated during itraconazole therapy.1 48 (See Specific Drugs under Interactions.)

Hepatic Impairment

Use caution; only limited data available on use in patients with hepatic impairment.1 48 Prolonged half-life in patients with cirrhosis.1 48 (See Pharmacokinetics.) This prolonged half-life in cirrhotic patients should be considered when deciding to initiate concomitant therapy with drugs that are metabolized by CYP3A4.1 48 (See Interactions.)

Use of itraconazole in patients with increased serum hepatic enzymes, active liver disease, or a history of liver toxicity with other drugs is strongly discouraged unless there is a serious or life-threatening situation when potential benefits outweigh risks.1 48

Monitor serum hepatic enzyme concentrations in patients with preexisting hepatic impairment and in those who have experienced liver toxicity with other drugs.1 48

Renal Impairment

Use caution; only limited data available on use in patients with renal impairment.1 48

Wide interindividual variations in AUC reported in patients with renal impairment.1 48 (See Absorption: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

GI effects (nausea, vomiting, diarrhea, abdominal pain, anorexia); rash and pruritus; CNS effects (headache, dizziness); hypokalemia.1 10 16 17 18 19 28 36 37 48

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Itraconazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

100 mg*

Itraconazole Capsules

Sporanox

Ortho-McNeil-Janssen

Solution

50 mg/5 mL

Sporanox

Centocor Ortho Biotech

Indications andusage

Itraconazole Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:

1. Blastomycosis, pulmonary and extrapulmonary

2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal

histoplasmosis, and

3. 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:

1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and

2. 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.(See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS,and ADVERSE REACTIONS: Post-marketing Experience for more information.)

                               

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 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 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 course 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.

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. (See ADVERSE REACTIONS.)

Patient Information


PATIENT INFORMATION

Itraconazole CAPSULES 100 mg

 

This summary contains important information about Itraconazole (IT-ra-KON-a-zole) Capsules. This information is for patients who have been prescribed Itraconazole Capsules to treat fungal nail infections. If your doctor prescribed Itraconazole Capsules 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 Capsules. This information does not take the place of discussion between you and your doctor. Only your doctor can decide if Itraconazole Capsules 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 CAPSULES?

Itraconazole Capsules is used to treat fungal nail infections. However, Itraconazole Capsules is not for everyone. Do not take Itraconazole Capsules for fungal nail infections if you have had heart failure, including congestive heart failure. You should not take Itraconazole Capsules 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 Capsules.


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 CAPSULES?

Itraconazole Capsules 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 Capsules works in children with fungal nail infections or if it is safe for children to take.
Itraconazole Capsules 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 Capsules. 

Itraconazole Capsules 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 CAPSULES ?

Itraconazole Capsules is not for everyone. Your doctor will decide if  Itraconazole Capsules is the right treatment for you. Some patients should not take Itraconazole Capsules 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 cystic fibrosis, or have had an allergic reaction to Itraconazole Capsules  or any other antifungal medicines.


Never take Itraconazole Capsules if you:

·                     have had heart failure, including congestive heart failure.

·                     are taking any of the medicines listed below. Dangerous or even life-threatening side effects could result:


  • cisapride (such as Propulsid®)
  • colchicine (such as Colcrys™) [if you also have pre-existing kidney or liver impairment]
  • disopyramide (such as Norpace®)
  • dofetilide (such as Tikosyn™)
  • dronedarone (such as Multaq®)
  • eplerenone (such as Inspra®)
  • ergot alkaloids (such as Migranal®, Ergonovine, Cafergot®, Methergine®)
  • felodipine (such as Plendil®)
  • fesoterodine (such as Toviaz®) [if you also have pre-existing kidney or liver impairment]
  • irinotecan (such as Camptosar®)
  • ivabradine (such as Corlanor®)
  • lovastatin (such as Mevacor®, Advicor®, Altocor™)
  • lurasidone (such as Latuda®)
  • methadone (such as Dolophine®)
  • midazolam (such as Versed®)
  • nisoldipine (such as Sular®)
  • pimozide (such as Orap®)
  • quinidine (such as Cardioquin®, Quinaglute®, Quinidex®)
  • ranolazine (such as Ranexa®)
  • simvastatin (such as Zocor®)
  • solifenacin (such as Vesicare®) [if you also have pre-existing kidney or liver impairment]
  • telithromycin (such as Ketek®) [if you also have pre-existing kidney or liver impairment]
  • ticagrelor (such as Brilinta®)
  • triazolam (such as Hacion®)
  • have ever had an allergic reaction to Itraconazole

Taking Itraconazole Capsules with certain other medicines may 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.Your doctor will decide if Itraconazole Capsules is the right treatment for you.

 

WHAT SHOULD I KNOW ABOUT Itraconazole CAPSULES AND PREGNANCY OR BREAST FEEDING?

Never take Itraconazole Capsules 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 Capsules 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 Capsules .

 

HOW SHOULD I TAKE Itraconazole CAPSULES ?

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 Capsules once a day for 12 weeks, or twice a day for 1 week in a dosing schedule. You will receive either a bottle of capsules or a blister pack. Do not skip any doses. Be sure to finish all your Itraconazole Capsules 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 Capsules can develop liver problems.

Itraconazole Capsules 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 Capsules , ask your doctor what you should do with the missed doses.


WHAT ARE THE POSSIBLE SIDE EFFECTS OF Itraconazole CAPSULES ?

The most common side effects include: headache, and digestive system problems (such as nausea, and abdominal pain).


Stop Itraconazole Capsules 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 oversensitivity to sunlight, a tingling sensation in the limbs or a severe skin disorder can occur. If any of these symptoms occur, stop taking  Itraconazole Capsules and contact your doctor.


Stop Itraconazole Capsules 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 Capsules could develop serious heart problems, and these could be warning signs of heart failure.


Stop Itraconazole Capsules 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 Capsules could develop serious liver problems and these could be warning signs.


Stop Itraconazole Capsules and call your doctor right away if you experience any hearing loss symptoms. In  very rare cases, patients taking Itraconazole Capsules 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 disorders, erectile dysfunction, dizziness,muscle pain, painful joints, unpleasant taste, or hair loss. These are not all the side effects of  Itraconazole Capsules. Your doctor or pharmacist can give you a more complete list.

 

WHAT SHOULD I DO IF I TAKE AN OVERDOSE OF Itraconazole CAPSULES ?

If you think you took too much Itraconazole Capsules , call your doctor or local poison control center, or go to the nearest hospital emergency room right away.

 

HOW SHOULD I STORE Itraconazole CAPSULES ?

Keep all medicines, including Itraconazole Capsules, out of the reach of children.

Store Itraconazole Capsules at room temperature in a dry place away from light.

 

GENERAL ADVICE ABOUT Itraconazole CAPSULES

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use Itraconazole Capsules for a condition for which it was not prescribed. Do not give Itraconazole Capsules 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 Capsules . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Itraconazole Capsules that is written for health professionals or you can call Northstar RxLLC at 1-800-206-7821 

This patient information has been approved by the U.S. Food and Drug Administration.

 
Issued: June,2017
                                                                               

Manufactured for:

Northstar Rx LLC

Memphis, TN 38141.

Manufactured by:

Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA

PT 2958

Package label.principal display panel

NDC 16714-743-02
Itraconazole CAPSULES 100 mg
30 Capsules
Rx Only



NDC 16714-743-01
Itraconazole CAPSULES 100 mg
28 Capsules (7X4)
Rx Only


Itraconazole 
Itraconazole capsule, coated pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16714-743
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Itraconazole (Itraconazole) Itraconazole 100 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE  
HYPROMELLOSE 2910 (5 MPA.S)  
POLOXAMER 188  
ALCOHOL  
METHYLENE CHLORIDE  
POLYETHYLENE GLYCOL 20000  
TALC  
SILICON DIOXIDE  
GELATIN  
TITANIUM DIOXIDE  
SODIUM LAURYL SULFATE  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C RED NO. 3  
SHELLAC  
ISOPROPYL ALCOHOL  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
AMMONIA  
POTASSIUM HYDROXIDE  
STARCH, CORN  
Product Characteristics
Color BLUE (Blue Opaque) , PINK (Pink transparent) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code ITR;100
Contains     
Packaging
# Item Code Package Description
1 NDC:16714-743-02 30 CAPSULE, COATED PELLETS in 1 BOTTLE
2 NDC:16714-743-01 7 BLISTER PACK in 1 CARTON
2 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208591 09/01/2017
Labeler - NorthStar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(16714-743)
Revised: 09/2017   NorthStar RxLLC

Special Populations Renal Function Impairment

Bioavailability is slightly reduced.

Use Labeled Indications

Aspergillosis (capsules): Treatment of pulmonary and extrapulmonary aspergillosis in immunocompromised and nonimmunocompromised patients who are intolerant of or refractory to amphotericin B therapy. Note: IDSA Aspergillosis guidelines recommend amphotericin B formulations for invasive aspergillosis (initial or salvage) only when voriconazole is contraindicated or not tolerated (IDSA [Patterson 2016]).

Blastomycosis (capsules): Treatment of pulmonary and extrapulmonary blastomycosis in immunocompromised and nonimmunocompromised patients.

Histoplasmosis (capsules): Treatment of histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis in immunocompromised and nonimmunocompromised patients.

Onychomycosis:

Capsules: Treatment of onychomycosis of the toenail, with or without fingernail involvement, and onychomycosis of the fingernail caused by dermatophytes (tinea unguium) in nonimmunocompromised patients

Tablets: Treatment of onychomycosis of the toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes in nonimmunocompromised patients

Oropharyngeal/Esophageal candidiasis (oral solution): Treatment of oropharyngeal and esophageal candidiasis

Canadian labeling: Oral capsules: Additional indications (not in US labeling):

Candidiasis, oral and/or esophageal: Treatment of oral and/or esophageal candidiasis in immunocompromised and immunocompetent patients

Chromomycosis: Treatment of chromomycosis in immunocompromised and immunocompetent patients

Dermatomycoses: Treatment of dermatomycoses due to tinea pedis, tinea cruris, tinea corporis, and of pityriasis versicolor in patients for whom oral therapy is appropriate

Onychomycosis: Treatment of onychomycosis in immunocompromised and immunocompetent patients

Paracoccidioidomycosis: Treatment of paracoccidioidomycosis in immunocompromised and immunocompetent patients

Sporotrichosis: Treatment of cutaneous and lymphatic sporotrichosis in immunocompromised and immunocompetent patients

Off Label Uses

Candidiasis, vulvo-vaginal in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole oral solution is an effective and recommended alternative agent in the management of vulvo-vaginal candidiasis in adolescent and adult HIV-infected patients.

Coccidioidal meningitis in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole is an effective and recommended alternative agent in the treatment of and as chronic suppressive therapy of coccidioidal meningitis in adolescent and adult HIV-infected patients.

Coccidioidal pneumonia in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole is an effective and recommended agent in the treatment of coccidioidal pneumonia (focal pneumonia) in adolescent and adult HIV-infected patients.

Coccidioidomycosis (non-HIV infected)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the treatment of coccidioidomycosis, itraconazole is an effective and recommended agent for the treatment of coccidioidomycosis, including coccidioidal meningitis and certain types of pulmonary and extrapulmonary infections.

Cryptococcosis in HIV-infected patients (adults and adolescents)

Based on the HHS Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole is an effective and recommended alternative agent in the treatment (consolidation therapy) of cryptococcal meningitis in adolescent and adult HIV-infected patients.

Histoplasmosis (primary prophylaxis/long-term suppression therapy) in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole is an effective and recommended agent in the prophylaxis of histoplasmosis as primary prophylaxis or as long-term suppressive therapy in adolescent and adult HIV-infected patients.

Microsporidiosis, disseminated in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole is an effective and recommended agent in the management of disseminated microsporidiosis caused by Trachipleistophora or Anncaliia in adolescent and adult HIV-infected patients.

Penicilliosis in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, itraconazole is an effective and recommended agent in the treatment or primary prophylaxis of penicilliosis in adolescent and adult HIV-infected patients.

Additional off-label uses

Blastomycosis in pediatric patients; candidiasis (oral/esophageal) in pediatric patients; coccidioidomycosis in pediatric patients; cryptococcosis in pediatric patients; histoplasmosis in pediatric patients; sporotrichosis in pediatric patients

Contraindications

Hypersensitivity to itraconazole or any component of the formulation; concurrent administration with cisapride, disopyramide, dofetilide, dronedarone, eplerenone, ergot derivatives, felodipine, irinotecan, ivabradine, lovastatin, lurasidone, methadone, midazolam (oral), nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, or triazolam; concurrent administration with colchicine, fesoterodine, telithromycin, and solifenacin in patients with varying degrees of renal or hepatic impairment; treatment of onychomycosis (or other non-life-threatening indications) in patients with evidence of ventricular dysfunction, such as congestive heart failure (CHF) or a history of CHF; treatment of onychomycosis in women who are pregnant or contemplating pregnancy

Canadian labeling: Additional contraindications (not in US labeling): Concurrent administration with domperidone, eletriptan, fesoterodine in patients with moderate to severe renal or hepatic impairment, or solifenacin in patients with severe renal impairment or moderate to severe hepatic impairment (capsule, oral solution); Concurrent administration with the following drugs (none of which are available in Canada): Astemizole, bepridil, halofantrine, ivabradine, lercanidipine, levacetylmethadol, mizolastine, telithromycin (in patients with severe renal or hepatic impairment), sertindole, terfenadine (capsule, oral solution); treatment of dermatomycosis (tinea pedis, tinea cruris, tinea corporis, pityriasis versicolor) in women who are pregnant or intend to become pregnant (capsule)

Storage

Capsule: Store at room temperature of 15°C to 25°C (59°F to 77°F). Protect from light and moisture.

Oral solution: Store at ≤25°C (77°F); do not freeze.

Tablet: Store at room temperature 15°C to 25°C (59°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, abdominal pain, nausea, vomiting, diarrhea, flatulence, rhinorrhea, or bad taste in mouth. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than 5 pounds in 24 hours, dizziness, or passing out), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of a pancreas problem (pancreatitis; severe abdominal pain, severe back pain, severe nausea, vomiting), burning or numbness feeling, blood in urine, breast pain, enlarged breasts, urinary retention, change in amount of urine passed, angina, tachycardia, sexual dysfunction, depression, dysphagia, severe dizziness, passing out, chills, pharyngitis, alopecia, joint pain, tinnitus, tremors, insomnia, bruising, bleeding, dry mouth, dry eyes, vision changes, loss of strength and energy, or hearing impairment (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

For Healthcare Professionals

Applies to itraconazole: compounding powder, intravenous kit, oral capsule, oral solution, oral tablet

General

In clinical trials, side effects were reported in about 7% to 9% of patients receiving short-term therapy and about 15% of patients receiving prolonged (about 1 month) continuous therapy.[Ref]

Gastrointestinal

Pancreatitis, abdominal pain, vomiting, dyspepsia, nausea, diarrhea, and constipation have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Nausea (up to 11%), diarrhea (up to 11%)
Common (1% to 10%): Vomiting, abdominal pain or discomfort, dyspepsia, flatulence, gingivitis, constipation, ulcerative stomatitis, gastritis, gastroenteritis
Rare (less than 0.1%): Pancreatitis
Frequency not reported: Dysphagia, hemorrhoids, gastrointestinal disorder[Ref]

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 11%)
Common (1% to 10%): Hypokalemia, increased blood alkaline phosphatase, hypomagnesemia, increased blood lactate dehydrogenase, hypophosphatemia, increased appetite
Uncommon (0.1% to 1%): Fluid overload, hypocalcemia, anorexia, hyperglycemia
Frequency not reported: Dehydration, decreased weight, hyperkalemia[Ref]

Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, hypoacusis, tremor, dysgeusia
Uncommon (0.1% to 1%): Vertigo, somnolence, hypoesthesia, transient or permanent hearing loss, peripheral neuropathy
Rare (less than 0.1%): Paresthesia, tinnitus[Ref]

Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness, tinnitus, transient or permanent hearing loss, dysgeusia, and tremor have also been reported during postmarketing experience.[Ref]

Respiratory

Common (1% to 10%): Rhinitis, upper respiratory tract infection, sinusitis, cough, pneumonia, increased sputum, dyspnea, pharyngitis, pulmonary infiltration
Uncommon (0.1% to 1%): Pulmonary edema, pharyngolaryngeal pain
Frequency not reported: Dysphonia[Ref]

Pulmonary edema and dyspnea have also been reported during postmarketing experience.[Ref]

Other

Edema and pyrexia have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Pyrexia, injury, edema, chest pain, fatigue, malaise, pain, asthenia, Pneumocystis carinii infection, herpes zoster
Frequency not reported: Unspecified infection, rigors, back pain, hot flushes, implantation complication, face edema, chills, generalized edema
Postmarketing reports: Peripheral edema[Ref]

Dermatologic

Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, rash, pruritus, and urticaria have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Rash, pruritus, hyperhidrosis, unspecified skin disorder, erythematous rash
Uncommon (0.1% to 1%): Urticaria
Rare (less than 0.1%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, alopecia[Ref]

Hepatic

Common (1% to 10%): Increased hepatic enzymes (including reversible increases), bilirubinemia, abnormal liver function, increased ALT, jaundice, increased AST, increased GGT, hepatitis, hyperbilirubinemia
Rare (less than 0.1%): Serious hepatotoxicity (including some cases of fatal acute liver failure)
Frequency not reported: Cholestasis, cholestatic jaundice, hepatic failure[Ref]

Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy.

Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, and reversible increases in hepatic enzymes have also been reported during postmarketing experience.[Ref]

Cardiovascular

Congestive heart failure has also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Hypertension, vein disorder, abnormal electrocardiogram
Uncommon (0.1% to 1%): Hypotension, orthostatic hypotension, vasculitis, sinus bradycardia, tachycardia
Rare (less than 0.1%): Congestive heart failure
Frequency not reported: Premature ventricular contractions, cardiac failure, left ventricular failure[Ref]

Renal

Common (1% to 10%): Increased serum creatinine
Uncommon (0.1% to 1%): Abnormal renal function, increased blood urea
Frequency not reported: Renal impairment[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, abnormal dreaming
Frequency not reported: Insomnia, decreased libido, visual hallucinations, confusional state[Ref]

An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later.[Ref]

Genitourinary

Pollakiuria, menstrual disorders, and erectile dysfunction have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Cystitis, urinary tract infection
Uncommon (0.1% to 1%): Impotence, menstrual disorders, abnormal urine analysis
Rare (less than 0.1%): Pollakiuria, erectile dysfunction
Frequency not reported: Albuminuria, hematuria, gynecomastia, male breast pain, bacteriuria
Postmarketing reports: Urinary incontinence[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, bursitis, back pain
Rare (less than 0.1%): Increased blood creatine phosphokinase
Postmarketing reports: Arthralgia[Ref]

Increased blood creatine phosphokinase and myalgia have also been reported during postmarketing experience.[Ref]

Local

IV:
Common (1% to 10%): Application site reaction
Frequency not reported: Injection site inflammation[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Rare (less than 0.1%): Allergic reactions (e.g., pruritus, rash, urticaria, angioedema), serum sickness, angioneurotic edema, anaphylactic reaction
Frequency not reported: Anaphylactic shock
Postmarketing reports: Anaphylaxis, anaphylactoid reaction[Ref]

At least 1 case of anaphylactic shock after long-term IV therapy has been reported.

Anaphylactic reactions, allergic reactions, serum sickness, and angioneurotic edema have also been reported during postmarketing experience.[Ref]

Ocular

Visual disturbances (including blurred vision, diplopia) have also been reported during postmarketing experience.[Ref]

Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia)
Frequency not reported: Abnormal vision[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia
Frequency not reported: Granulocytopenia
Postmarketing reports: Neutropenia, thrombocytopenia[Ref]

Leukopenia has also been reported during postmarketing experience.[Ref]

Endocrine

Frequency not reported: Adrenal insufficiency[Ref]

Some side effects of itraconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Sporotrichosis

IDSA Recommendations:
Cutaneous or lymphocutaneous infection:
-Recommended dose: 200 mg orally once a day
-If patients do not respond: 200 mg orally twice a day
Duration of therapy: 2 to 4 weeks after all lesions resolve (usually 3 to 6 months total)

Osteoarticular infection: 200 mg orally twice a day
Total duration of therapy: At least 12 months

Less severe pulmonary infection: 200 mg orally twice a day
Duration of therapy: At least 12 months

Meningeal infection, disseminated infection, or severe or life-threatening pulmonary infection (after initial regimen of IV amphotericin B): 200 mg orally twice a day
Total duration of therapy: At least 12 months

Prevention of recurrence of meningeal infection or disseminated infection (secondary prophylaxis) in patients with AIDS and other immunosuppressed patients: 200 mg orally once a day

Comments:
-Recommended as preferred therapy
-The oral solution formulation is preferred.

Usual Adult Dose for Systemic Fungal Infection

IDSA Recommendations:
Empirical therapy: 200 mg orally twice a day

Comments:
-Recommended as alternative therapy for suspected invasive candidiasis in neutropenic patients

Usual Adult Dose for Tinea Versicolor

Study (n=36)
200 mg orally once a day for 7 days

Usual Pediatric Dose for Coccidioidomycosis

CDC, NIH, IDSA, PIDS, and AAP Recommendations for HIV-exposed and HIV-infected Children:
Mild to moderate nonmeningeal infection (e.g., focal pneumonia): 2 to 5 mg/kg orally 3 times a day for 3 days, then 2 to 5 mg/kg orally twice a day
Maximum dose: 200 mg/dose
Duration of therapy: Determined by rate of clinical response

Lifelong suppression (secondary prophylaxis): 2 to 5 mg/kg orally twice a day
Maximum dose: 200 mg/dose

Comments:
-Recommended as alternative therapy for secondary prophylaxis and mild to moderate nonmeningeal infections
-Preferred therapy for severe illness with respiratory compromise due to diffuse pulmonary or disseminated nonmeningeal infection includes treatment with IV amphotericin B; after patient is stabilized, an azole (this drug preferred for bone infections) can be substituted and continued for a total duration of therapy of 1 year; some experts start an azole during amphotericin B therapy.

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Mild infection (e.g., focal pneumonia): 200 mg orally twice a day
Severe nonmeningeal infection (diffuse pulmonary or severely ill patients with extrathoracic disseminated infection) - acute phase: 400 mg orally per day
Meningeal infection: 200 mg orally twice a day
Chronic suppressive therapy (secondary prophylaxis): 200 mg orally twice a day

Comments:
-Recommended as preferred therapy for mild infections and chronic suppressive therapy
-Preferred therapy for severe nonmeningeal infections includes treatment with IV amphotericin B until clinical improvement followed by a triazole; as alternative therapy, some experts add a triazole (this drug preferred for bone disease) to amphotericin B therapy and continue the triazole after amphotericin B is stopped.
-Recommended as alternative therapy for meningeal infections; a specialist should be consulted.

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