Sporanox

Sporanox

itraconazole

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Itraconazole
Indications/Uses
Vulvovag candidiasis; pityriasis versicolor; dermatomycosis including highly keratinised regions as in plantar tinea pedis & palmar tinea manus; fungal keratitis; oral candidiasis; onychomycosis caused by dermatophytes or yeasts. Systemic mycoses only in the following fungal infections: Systemic aspergillosis & candidiasis; histoplasmosis; sporotrichosis including lymphocutaneous/cutaneous & extracutaneous; paracoccidioidomycosis; chromomycosis; blastomycosis. Maintenance therapy in AIDS patients w/ histoplasmosis.
Dosage/Direction for Use
Vulvovag candidiasis 200 mg twice daily for 1 day or 200 mg once daily for 3 days. Pityriasis versicolor 100 mg twice daily or 200 mg once daily for 5-7 days. Dermatomycosis 100 mg once daily for 15 days or 200 mg once daily for 7 days. Dermatomycosis in highly keratinised regions 200 mg twice daily for 7 days or 100 mg once daily for 30 days. Oral candidiasis 100 mg once daily for 15 days. Fungal keratitis 200 mg once daily for 21 days or adjusted to clinical response. Onychomycosis Pulse treatment for toenails w/ or w/o fingernail involvement: 200 mg twice daily on wk 1, wk 5 & wk 9 separated by 3-wk treatment-free intervals. Pulse treatment for fingernails only: 200 mg twice daily on wk 1 & wk 5 separated by a 3-wk treatment-free interval. Continuous treatment: 200 mg once daily for 3 mth. Aspergillosis 200 mg once daily for 2-5 mth. Increase dose to 200 mg twice daily in case of invasive or disseminated disease. Candidiasis 100-200 mg once daily for 3 wk-7 mth. Increase dose to 200 mg twice daily in case of invasive or disseminated disease. Histoplasmosis 200 mg once to twice daily for 8 mth. Maintenance in AIDS patient w/ histoplasmosis 200 mg once or twice daily until immune recovery. Lymphocutaneous & cutaneous sporotrichosis Localized lesions: 100 or 200 mg once daily for 3-6 mth. Extensive lesions: 200 mg twice daily for 3-6 mth. Extracutaneous sporotrichosis 200 mg twice daily for 12 mth. Paracoccidioido-mycosis 100 mg once daily for 6 mth. Chromomycosis 200 mg once daily for 6 mth. Blastomycosis 100 mg once daily to 200 mg twice daily for 6 mth.
Administration
Should be taken with food: Take immediately after a full meal. Swallow whole.
Contraindications
Hypersensitivity. Co-administration w/ CYP3A4 substrates. Patients w/ evidence of ventricular dysfunction eg, CHF or history of CHF, except for treatment of life-threatening or other serious infections. Pregnant women except for the treatment of systemic mycoses where potential advantages outweigh the potential harm to the foetus.
Special Precautions
Hypersensitivity to other azoles. Patients w/ cardiac disease eg, ischaemic & valvular disease; significant pulmonary disease eg, COPD; renal failure & other oedematous disorders; reduced gastric acidity; cystic fibrosis. Monitor for signs & symptoms of CHF. Co-administration w/ Ca-channel blockers. Discontinue if neuropathy, symptoms of CHF occurs. Immunocompromised patients eg, neutropenic & AIDS patients or organ transplant patients. Not recommended for initiation of treatment in patients w/ immediately life-threatening systemic fungal infections. Evaluate need for maintenance therapy in AIDS patients previously treated for systemic fungal infection. Hearing loss may occur. Conduct sensitivity testing if fluconazole-resistant strains of Candida spp are suspected prior to initiation of therapy. It is not recommended that Sporanox cap & oral soln be used interchangeably. May impair ability to drive & use machines. Hepatic & renal impairment. Must not be used during pregnancy except in life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus. Women of childbearing potential should use contraceptive precautions. Lactation. Childn. Elderly.
Adverse Reactions
Drug Interactions
Decreased bioavailability w/ moderate or potent CYP3A4 inducers. Increased bioavailability w/ CYP3A4 inhibitors. Reduced absorption from cap formulation w/ reduced gastric acidity. May inhibit metabolism of drugs metabolised by CYP3A4. May inhibit drug transport by P-gp &/or BCRP.
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
7 × 4's (Rp1,008,823/boks)
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