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Spyrocon

Spyrocon

itraconazole

Manufacturer:

Interbat
Concise Prescribing Info
Contents
Itraconazole
Indications/Uses
Short-term therapy of dermatomycosis, fungal keratitis, pityriasis versicolor, oral & vulvovag candidiasis. Long-term therapy of onychomycosis & systemic mycosis: aspergillosis, blastomycosis, histoplasmosis, candidiasis, cryptococcosis (including cryptococcal meningitis), paracoccidioidomycosis, sporotrichosis.
Dosage/Direction for Use
Dermatomycosis, oral candidiasis 100 mg once daily for 15 days. Pityriasis versicolor 200 mg once daily for 7 days. Vulvovag candidiasis 200 mg twice daily for 1 day or 200 mg once daily for 3 days. Highly keratinized regions (plantar tinea pedis & palmar tinea manus): Additional 100 mg daily for 15 days. Fungal keratitis 200 mg once daily for 21 days. Aspergillosis 200 mg once daily for 2-5 mth. Candidiasis 100-200 mg once daily for 3-7 wk. Invasive or disseminated disease: Increase dose to 200 mg twice daily. Non-meningeal cryptococcosis 200 mg once daily for 2 mth-1 yr. Cryptococcal meningitis 200 mg twice daily for 2 mth-1 yr. Maintenance (meningeal cases): 200 mg once daily. Blastomycosis 100 mg once daily or 200 mg twice daily for 6 mth. Histoplasmosis 200 mg once or twice daily for 8 mth. Paracoccidioidomycosis 100 mg once daily for 6 mth. Sporotrichosis 100 mg once daily for 3 mth.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
Special Precautions
Promptly monitor liver enzymes if during treatment patients develop symptoms (eg, fatigue, nausea, vomiting, anorexia, abdominal pain or dark urine) & if abnormal, treatment should be stopped. Do not start treatment in patients w/ raised liver enzymes unless expected benefit exceeds risk of hepatic injury. Discontinue treatment if neuropathy occurs that may be attributable to itraconazole. Oral bioavailability of itraconazole may be lower in cirrhotic patients & in patients w/ renal insufficiency. Monitor itraconazole plasma conc & adapt the dose when necessary. Administration in childbearing women must be together w/ contraceptive pill & must be continued for one menstruation period once therapy has stopped. Not to be given to pregnant women. Paed patients.
Adverse Reactions
Short-term: headache, dizziness, nausea, stomach disorder, dyspepsia, rash, pruritus, urticaria, angioedema, reversible increasement of hepatic enzymes. An isolated case of SJS. Long-term: edema, GI disturbance, reversible increase in hepatic enzymes, hair loss, hepatitis & peripheral neuropathy.
Drug Interactions
Decreased plasma level when used concomitantly w/ rifampicin & phenytoin. Decreased absorption w/ antacid, absorbent or histamine H2-antagonist. Accelerated metabolism w/ rifampicin. Potential interaction w/ cyclosporin A, warfarin & digoxin.
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
Spyrocon cap 100 mg
Packing/Price
3 × 4's
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