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Sporanox

Sporanox

itraconazole

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Itraconazole
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
Should be taken with food: Take immediately after a full meal.
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. Not to be initiated in patients w/ immediately life-threatening systemic fungal infections. 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.
Adverse Reactions
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. Inhibited drug transport by P-gp &/or BCRP & increased plasma conc of P-gp &/or BCRP drugs.
MIMS Class
Antifungals
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Sporanox cap 100 mg
Packing/Price
28's
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