Ketoconazole, Oral
Antifungal, Systemic · Imidazole antifungal
Indications
Systemic mycoses, prophylaxis of mycoses in patients with reduced immune responses. Serious chronic mucocutaneous candidiasis and serious mycoses of the Gl tract not responsive to other therapy. Culturally determined dermatophyte infections not responsive to other therapy excluding infection of the toe nails or for pityriasis versicolor.
Dosage
Adults: 200-400 mg once daily with meals. May increase to 400 mg daily. Continue for at least one wk after symptoms have cleared. Children: >2 yr, 3.3-6.6 mg/kg, once daily with meals; for candidiasis 1-2 wk; for 4 wk in recalcitrant, dermatophyte infections; up to 6 mth for other systemic mycoses.
Adverse Effects
Altered liver function tests and hepatitis. Hypersensitivity reactions. Gl upsets, rashes, headache, thrombocytopenia. Gynaecomastia (rare).
Risk Factor (Pregnancy/Lactation)
Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Pre-existing liver disease or significant abnormalities on liver function tests. Precautions: Monitor patients for signs of liver damage after first 10 days, then twice per month.
Interactions
Anticholinergics, antacids, H2-antagonists, anticoagulants, phenytoin, rifampicin, cyclosporin A.
Advice to Patient
Take with meals. Do not take within 2 hours of taking an antacid. Contact prescriber if there is unrelieved headache, itching, rash, yellowing of skin or eyes, colour change of stool or urine, chest pain, palpitations, ringing in ears, feeling of fullness. Complete full course of therapy even if you feel better. If you have diabetes, monitor blood glucose regularly and inform prescriber about the changes. Mild analgesic may be taken for headache.
Pharmacokinetics
Absorption: Variable. Increases with decreasing stomach pH. Metabolism: Hepatic. Half-life elimination: Biphasic: Initial: 2 hrs. Terminal: 8 hrs. Time to peak, plasma: 2 hrs. Excretion: Faeces (57%). Urine(13%).
Brands with this active ingredient
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