Community Pharm PCL


Community Pharm PCL
Full Prescribing Info
Each tablet contains ketoconazole 200 mg.
KETORAL is an imidazole antimycotic which is effective after oral administration and has a broad spectrum of activity against dermatophytes, yeasts and other pathogenic fungi.
Treatment of superficial and deep mycoses: Infections of the skin, hair and nails by dermatophytes and/or yeasts, (dermatomycosis, onychomycosis, perionyxis, pityriasis versicolor, chronic mucocutaneous candidosis, etc.) especially when topical treatment is difficult or not effective, owing to involvement of large skin surfaces or lesions affecting deeper dermal layers, nails and hairs; yeast infection of the mouth (oral thrush, perleche) and gastro-intestinal tract; vaginal candidosis, especially chronic recurrent cases or cases responding poorly to topical treatment; systemic mycotic infections such as systemic candidiasis, paracoccidioidomycosis, histoplasmosis, coccidioidomycosis, etc.
Maintenance treatment to prevent recurrence in systemic mycotic infections and in chronic mucocutaneous candidosis.
Prophylactic treatment to prevent mycotic infections in patients with reduced host defenses, e.g. patients with cancer, organ transplant, burns.
Dosage/Direction for Use
Vaginal candidosis: One tablet morning and evening for five to seven days.
All other indications: One tablet once daily until at least one week after the symptoms disappeared.
The usual duration of treatment is as follows: Oral thrush: 10 days.
Mycoses of the skin and hair: 1 to 2 months.
Aspergillosis, systemic candidosis: 1 to 2 months.
Paracoccidioidomycosis, histoplasmosis: 1 to 2 months.
Onychomycosis and chronic mucocutaneous candidosis: Up to 6 months.
In children, the dose is reduced to 50 or 100mg once daily, depending on the body weight (i.e. approximately 3 mg/kg).
Remark: KETORAL should be taken with meals for maximal resorption. Because resorption depends on intact gastric activity, concomitant treatment with agents that reduce gastric secretion (anticholinergic drugs, antacids, H2-antagonists) should be avoided. When indicated, such drugs should be taken not earlier than two hours after KETORAL intake. If clinical responsiveness is insufficient within the expected time, the dose of KETORAL may be doubled (400 mg once daily).
KETORAL is contraindicated in pregnancy.
Use In Pregnancy & Lactation
KETORAL is contraindicated in pregnancy.
Side Effects
Nausea and itching may occur.
MIMS Class
ATC Classification
J02AB02 - ketoconazole ; Belongs to the class of imidazole derivatives. Used in the systemic treatment of mycotic infections.
Tab 200 mg x 10 x 10's.
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