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Indications

REMS

Capsules:

Oral solution:

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

CV: edema, HF, hypertension.

Derm: photosensitivity, pruritus, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

EENT: hearing loss, tinnitus.

Endo: adrenal insufficiency.

F and E: hypokalemia.

GI: nausea, abdominal pain, anorexia, diarrhea, flatulence, HEPATOTOXICITY, vomiting.

GU: albuminuria, libido, erectile dysfunction.

MS: RHABDOMYOLYSIS.

Neuro: dizziness, drowsiness, fatigue, headache, malaise, neuropathy.

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Interactions

Drug-Drug:

Drug-Food:

Availability

(Generic available)

Route/Dosage

65–mg tablets are NOT interchangeable with other products.

Aspergillosis

Blastomycosis, Histoplasmosis

Onychomycosis

Candidiasis

US Brand Names

Onmel, Sporanox, Tolsura

Action

Therapeutic Effects:

Spectrum:

Classifications

Therapeutic Classification: antifungals (systemic)

Pharmacologic Classification: azoles

Pharmacokinetics

Absorption: Absorption is enhanced by food.

Distribution: Tissue concentrations are higher than plasma concentrations. Does not enter CSF; enters breast milk.

Protein Binding: Itraconazole — 99.8%; hydroxyitraconazole — 99.5%.

Metabolism/Excretion: Mostly metabolized by the liver by the CYP3A4 isoenzyme and excreted in feces. Hydroxyitraconazole, the major metabolite, has antifungal activity.

Half-life: 21 hr.

Time/Action Profile

(blood levels)

ROUTEONSETPEAKDURATION
POrapid4 hr12–24 hr

Patient/Family Teaching

Pronunciation

it-tra-KON-a-zole audio

Code

NDC Code*