Sporanox

Sporanox

itraconazole

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Itraconazole
Indications/Uses
Cap: Vulvovag & oral candidosis; dermatomycosis, plantar tinea pedis & palmar tinea manus, pityriasis versicolor; onychomycosis; systemic aspergillosis & candidosis; cryptococcosis eg, cryptococcal meningitis; histoplasmosis; blastomycosis; lymphocutaneous/cutaneous & extracutaneous sporotrichosis; paracoccidioidomycosis; chromomycosis. Oral soln: Oral &/or esophageal candidosis in HIV-positive or other immunocompromised patients. Prophylaxis of deep fungal infections.
Dosage/Direction for Use
Cap Vulvovag candidiasis 200 mg bd for 1 day or 200 mg once daily for 3 days. Dermatomycosis 200 mg once daily for 7 days or 100 mg once daily for 15 days. Plantar tinea pedis & palmar tinea manus 200 mg bd for 7 days or 100 mg once daily for 30 days. Pityriasis versicolor 100 mg bd or 200 mg once daily for 5-7 days. Oral candidosis 100 mg once daily for 15 days. Onychomycosis Pulse treatment: 200 mg bd for 1 wk. Each pulse treatment is separated by 3 wk drug-free interval. Continuous treatment: 200 mg once daily for 3 mth. Fingernail onychomycosis 2 pulse treatments. Toenail onychomycosis 3 pulse treatments. Aspergillosis 200 mg once daily for 2-5 mth, may be increased to 200 mg bd in invasive or disseminated disease. Candidosis 100-200 mg once daily for 3 wk-7 mth, may be increased to 200 mg bd in invasive or disseminated disease. Non-meningeal cryptococcosis 200 mg once daily for 2 mth-1 yr. Cryptococcal meningitis 200 mg bd for 2 mth-1 yr. Maintenance in AIDS patient 200 mg once daily until immune recovery. Histoplasmosis 200 mg once-bd for 8 mth. Maintenance in AIDS patient 200 mg once or bd until immune recovery. Blastomycosis 100 mg once daily-200 mg bd for 6 mth. Lymphocutaneous & cutaneous sporotrichosis 100 or 200 mg once daily (localized lesions) or 200 mg bd (extensive lesions) for 3-6 mth. Extracutaneous sporotrichosis 200 mg bd for 12 mth. Paracoccidioidomycosis 100 mg once daily for 6 mth. Chromomycosis 200 mg once daily for 6 mth. Oral soln Oral &/or oesophageal candidiasis 200 mg daily in 1 or 2 doses for 1 wk, swish around oral cavity for approx 20 sec & swallow. If no response after 1 wk, continue treatment for another wk. Fluconazole-resistant oral &/or oesophageal candidiasis 100-200 mg bd for 2 wk. If no response after 2 wk, continue treatment for another 2 wk. Not to use 400 mg daily dose for >14 days. Prophylaxis of fungal infection 5 mg/kg daily in 2 divided doses.
Administration
Cap: Should be taken with food: Take immediately after a full meal. Oral soln: Should be taken on an empty stomach: Refrain from eating for at least 1 hr after intake.
Contraindications
Hypersensitivity. Not to be administered to patients w/ ventricular dysfunction evidence eg, CHF or history of CHF. Co-administration w/ CYP3A4 substrates. Not to be used during pregnancy.
Special Precautions
Hypersensitivity to other azoles. Discontinue use if neuropathy occurs. Not to be used in patients w/ or history of CHF. Risk factors for CHF eg, cardiac & significant pulmonary disease, oedematous disorders. Hearing loss; reduced gastric acidity; cystic fibrosis. Immunocompromised patients, AIDS patients at risk for relapse. Elevated or abnormal liver enzymes or active liver disease. Cross-resistance. Interchangeability. May affect ability to drive & use machines. Hepatic & renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Lactation. Not recommended in childn. Elderly. Cap: Not to be initiated in patients w/ immediately life-threatening systemic fungal infections. Oral soln: Not to be initiated in patients at immediate risk of systemic candidosis.
Adverse Reactions
Headache; nausea, abdominal pain. Oral soln: Dysgeusia, dizziness; cough; diarrhea, vomiting, dyspepsia; rash; pyrexia.
Drug Interactions
Decreased bioavailability w/ moderate or potent CYP3A4 inducers. Increased bioavailability w/ moderate or potent CYP3A4 inhibitors. Impaired absorption w/ drugs reducing gastric acidity. Inhibited metabolism of CYP3A4 metabolized drugs. Increased plasma conc of P-glycoprotein &/or breast cancer resistance protein drugs.
MIMS Class
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Sporanox cap 100 mg
Packing/Price
28's
Form
Sporanox oral soln 10 mg/mL
Packing/Price
(cherry flavour) 150 mL x 1's
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