COMPOSITION Each tablet contains keto cona zole 200 mg. PHARMACOLOGICAL CLASSIFICATION Antimicrobial (chemotherapeutic) agents. Fungicides. PHARMACOLOGICAL ACTION Keto cona zole is a synthetic imi da zole dioxolane derivative, active in vitro against dermatophytes, yeasts and other pathogenic fungi. INDICATIONS Treatment of superficial and deep mycoses: -Systemic mycotic infections such as systemic candidiasis; -Chronic and recurrent vaginal candidiasis not responding to topical treatment; CONTRA-INDICATION Patients with existing liver disease. Keto cona zole is contra-indicated in those patients who have shown hypersensitivity to keto-cona-zole or to any of the excipients. WARNINGS Keto cona zole has a potential for clinically important drug interactions. Decreased gastric acidity: Absorption is impaired when the gastric acidity is decreased. In patients also receiving acid neutralizing medicines(e.g. aluminium hydroxide) these should be administered at least 2 hours after the intake of ketoconazole. DOSAGE AND DIRECTIONS FOR USE Keto cona zole should be taken with meals for absorption. Chronic and recurrent vaginal candidiasis not responding to topical treatment: Two tablets (400 mg)once daily with a meal for 5 days. All other indications:One tablet (200 mg)once daily with a meal until at least one week after the symptoms have disappeared and until all cultures have become negative. The dose of keto cona zole may be doubled to 400 mg if the clinical response is insufficient after a reasonable period of treatment.
The usual duration of treatment is as follows: -Serious chronic mycoses of the skin and hair: 1 to 2 months; -Systemic candidiasis: 1 to 2 months; -Serious chronic mucocutaneous candidiasis: 6 to12 months; -Paracoccidioidomycosis and histoplasmosis: 2 to 6 months; -Dermatophytes: 4 weeks. SIDE-EFFECTS AND SPECIAL PRECAUTIONS The most frequently reported adverse experiences in association with the use of Keto cona zole were of gastro-intestinal origin, such as dyspepsia, nausea, vomiting, abdominal pain and diarch-oea. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT In the event of accidental overdosage, supportive measures including gastric lavage with sodium bicarbonate, should be employed. PRESENTATION Box containing ten blister packs of 10 tablets each. STORAGE INSTRUCTIONS Store below 25ºC in a dry place. Protect from light. keep out of reach of children.