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SPORANOX

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Overview

What is SPORANOX?

SPORANOX is the brand name for itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature:

(±)-1-[(*)--butyl]-4-[-[4-[-[[(2*,4*)-2-(2,4-dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ-1,2,4-triazolin-5-one mixture with (±)-1-[(*)--butyl]-4-[-[4-[-[[(2*,4*)-2-(2,4-dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ-1,2,4-triazolin-5-one

or

(±)-1-[()--butyl]-4-[-[4-[-[[(2,4)-2-(2,4-dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ-1,2,4-triazolin-5-one.

Itraconazole has a molecular formula of CHClNO and a molecular weight of 705.64. It is a white to slightly yellowish powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1.

SPORANOX (itraconazole) Oral Solution contains 10 mg of itraconazole per mL, solubilized by hydroxypropyl-β-cyclodextrin (400 mg/mL) as a molecular inclusion complex. SPORANOX Oral Solution is clear and yellowish in color with a target pH of 2. Other ingredients are hydrochloric acid, propylene glycol, purified water, sodium hydroxide, sodium saccharin, sorbitol, cherry flavor 1, cherry flavor 2 and caramel flavor.



What does SPORANOX look like?



What are the available doses of SPORANOX?

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What should I talk to my health care provider before I take SPORANOX?

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How should I use SPORANOX?

SPORANOX (itraconazole) Oral Solution is indicated for the treatment of oropharyngeal and esophageal candidiasis.

(See , , and for more information.)

The solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.

The recommended dosage of SPORANOX (itraconazole) Oral Solution for oropharyngeal candidiasis is 200 mg (20 mL) daily for 1 to 2 weeks. Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days.

For patients with oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets, the recommended dose is 100 mg (10 mL) b.i.d. For patients responding to therapy, clinical response will be seen in 2 to 4 weeks. Patients may be expected to relapse shortly after discontinuing therapy. Limited data on the safety of long-term use (>6 months) of SPORANOX Oral Solution are available at this time.

The recommended dosage of SPORANOX Oral Solution for esophageal candidiasis is 100 mg (10 mL) daily for a minimum treatment of three weeks. Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg (20 mL) per day may be used based on medical judgment of the patient's response to therapy.

SPORANOX Oral Solution and SPORANOX Capsules should not be used interchangeably. Patients should be instructed to take SPORANOX Oral Solution without food, if possible. Only SPORANOX Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.


What interacts with SPORANOX?

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What are the warnings of SPORANOX?

Hepatic Effects

SPORANOX 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, and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. Continued SPORANOX use or reinstitution of treatment with SPORANOX is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk.

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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 SPORANOX and/or other CYP3A4 inhibitors. Concomitant administration of these drugs with SPORANOX is contraindicated. (See , , and .)

Cardiac Disease

SPORANOX Oral Solution should not be used 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 SPORANOX 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 SPORANOX Oral Solution, monitor carefully and consider other treatment alternatives which may include discontinuation of SPORANOX Oral Solution 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.

SPORANOX 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 SPORANOX 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. (See , , , and for more information.)

Interaction potential

SPORANOX 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

SPORANOX (itraconazole) Oral Solution and SPORANOX Capsules 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. Only SPORANOX Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.

Hydroxypropyl-β-cyclodextrin

SPORANOX Oral Solution contains the excipient hydroxypropyl-β-cyclodextrin which produced adenocarcinomas in the large intestine and exocrine pancreatic adenocarcinomas in a rat carcinogenicity study. These findings were not observed in a similar mouse carcinogenicity study. The clinical relevance of these adenocarcinomas is unknown. (See .)

Treatment of Severely Neutropenic Patients

SPORANOX Oral Solution as treatment for oropharyngeal and/or esophageal candidiasis was not investigated in severely neutropenic patients. Due to its pharmacokinetic properties, SPORANOX Oral Solution is not recommended for initiation of treatment in patients at immediate risk of systemic candidiasis.


What are the precautions of SPORANOX?

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What are the side effects of SPORANOX?

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.

SPORANOX 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 SPORANOX use should be reassessed. (See and and .)

Adverse Events Reported in Oropharyngeal or Esophageal Candidiasis Trials

U.S. adverse experience data are derived from 350 immunocompromised patients (332 HIV seropositive/AIDS) treated for oropharyngeal or esophageal candidiasis. Table 5 below lists adverse events reported by at least 2% of patients treated with SPORANOX Oral Solution in U.S. clinical trials. Data on patients receiving comparator agents in these trials are included for comparison.

Adverse events reported by less than 2% of patients in U.S. clinical trials with SPORANOX included: adrenal insufficiency, asthenia, back pain, dehydration, dyspepsia, dysphagia, flatulence, gynecomastia, hematuria, hemorrhoids, hot flushes, implantation complication, infection unspecified, injury, insomnia, male breast pain, myalgia, pharyngitis, pruritus, rhinitis, rigors, stomatitis ulcerative, taste perversion, tinnitus, upper respiratory tract infection, vision abnormal, and weight decrease. Edema, hypokalemia and menstrual disorders have been reported in clinical trials with itraconazole capsules.

Table 5: Summary of Adverse Events Reported by ≥2% of SPORANOX Treated Patients in U.S. Clinical Trials (Total)
Itraconazole
Body System/ Adverse EventTotal(n = 350) %All controlled studies(n = 272) %Fluconazole(n = 125) %Clotrimazole (n = 81) %
Gastrointestinal disorders
  Nausea1110115
  Diarrhea1110104
  Vomiting7681
  Abdominal pain6477
  Constipation2210
Body as a whole
  Fever7685
  Chest pain3320
  Pain2240
  Fatigue2120
Respiratory disorders
  Coughing44100
  Dyspnea2351
  Pneumonia2200
  Sinusitis2240
  Sputum increased2331
Skin and appendages disorders
  Rash4546
  Increased sweating3461
  Skin disorder unspecified 2221
Central/peripheral nervous system
  Headache4466
  Dizziness2241
Resistance mechanism disorders
  Pneumocystis carinii infection 2220
Psychiatric disorders
  Depression2101


Adverse Events Reported from Other Clinical Trials

A comparative clinical trial in patients who received intravenous itraconazole followed by SPORANOX Oral Solution or received Amphotericin B reported the following adverse events in the itraconazole intravenous/SPORANOX Oral Solution treatment arm which are not listed above in the subsection "Adverse Events Reported in Oropharnyngeal or Esophageal Candidiasis Trials" or listed below as postmarketing reports of adverse drug reactions: serum creatinine increased, blood urea nitrogen increased, renal function abnormal, hypocalcemia, hypomagnesemia, hypophosphatemia, hypotension, tachycardia and pulmonary infiltration.

In addition, the following adverse drug reactions were reported in patients who participated in SPORANOX Oral Solution clinical trials:

Cardiac Disorders:

General Disorders and Administration Site Conditions:

Hepatobiliary Disorders:

Metabolism and Nutrition Disorders:

Reproductive System and Breast Disorders:

The following is a list of additional adverse drug reactions associated with itraconazole that have been reported in clinical trials of SPORANOX Capsules and itraconazole IV excluding the adverse reaction term "Injection site inflammation" which is specific to the injection route of administration:

Cardiac Disorders:

Gastrointestinal Disorders:

General Disorders and Administration Site Conditions:

Hepatobiliary Disorders:

Investigations:

Metabolism and Nutrition Disorders:

Nervous System Disorders:

Psychiatric Disorders:

Renal and Urinary Disorders:

Respiratory, Thoracic and Mediastinal Disorders:

Skin and Subcutaneous Tissue Disorders:

Vascular Disorders:

In addition, the following adverse drug reaction was reported in children only who participated in SPORANOX Oral Solution clinical trials: mucosal inflammation.

Post-marketing Experience

Adverse drug reactions that have been first identified during post-marketing experience with SPORANOX (all formulations) are listed in Table 6 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.

There is limited information on the use of SPORANOX 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 SPORANOX has not been established. (See , , , and for more information.)

Table 6: Postmarketing Reports of Adverse Drug Reactions
Blood and Lymphatic System Disorders:Leukopenia, neutropenia, thrombocytopenia
Immune System Disorders:Anaphylaxis; anaphylactic, anaphylactoid and allergic reactions; serum sickness; angioneurotic edema
Metabolism and Nutrition Disorders:Hypertriglyceridemia
Nervous System Disorders:Peripheral neuropathy, paresthesia, hypoesthesia, tremor
Eye Disorders:Visual disturbances, including vision blurred and diplopia
Ear and Labyrinth Disorders:Transient or permanent hearing loss
Cardiac Disorders:Congestive heart failure
Respiratory, Thoracic and Mediastinal Disorders:Pulmonary edema
Gastrointestinal Disorders:Pancreatitis
Hepatobiliary DisordersSerious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes
Skin and Subcutaneous Tissue Disorders:Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, urticaria
Musculoskeletal and Connective Tissue Disorders:Arthralgia
Renal and Urinary Disorders:Urinary incontinence, pollakiuria
Reproductive System and Breast Disorders:Erectile dysfunction
General Disorders and Administration Site Conditions:Peripheral edema
Investigations:Blood creatine phosphokinase increased



What should I look out for while using SPORANOX?


What might happen if I take too much SPORANOX?

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 .)


How should I store and handle SPORANOX?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].SPORANOX (itraconazole) Oral Solution is available in 150 mL amber glass bottles (NDC 50458-295-15) containing 10 mg of itraconazole per mL.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
Rare cases of serious hepatotoxicity have been observed with SPORANOX treatment, including some cases within the first week. It is recommended that liver function monitoring be considered in all patients receiving SPORANOX. Treatment should be stopped immediately and liver function testing should be conducted in patients who develop signs and symptoms suggestive of liver dysfunction.

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.

SPORANOX 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 SPORANOX use should be reassessed. (See and and .)

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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