Ketoconazole interacts with 14-α-sterol demethylase, a cytochrome P-450 enzyme necessary for the conversion of lanosterol to ergosterol. This results in inhibition of ergosterol synthesis and increased fungal cellular permeability due to reduced amounts of ergosterol present in the fungal cell membrane. This metabolic inhibition also results in the accumulation of 14α-methyl-3,6-diol, a toxic metabolite. The increase in membrane fluidity is also thought to produce impairment of membrane-bound enzyme systems as components become less closely packed.
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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 candidiasis etc.) especially when topical treatment is difficult or not very effective, owing to involvement of large skin surfaces or to lesions affecting deeper dermal layers, nails and hairs Yeast infection of the mouth (oral thrush, perleche) and the gastrointestinal tract Vaginal candidiasis, especially chronic recurrent cases or cases responding poorly to topcial 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 candidiasis. বাংলায় দেখুন Prophylactic treatment to prevent mycotic infection in patients with reduced host defenses, e.g., patients with cancer, organ transplant, and burns
Vaginal Candidiasis:
200 mg twice daily for 5 days.
All Other Indications:
Adults: 200 mg once daily, continued for at least one week after clinical symptoms resolve and mycological cultures become negative.
Children: 3–5 mg/kg/day.
Pityriasis versicolor: 1–6 weeks
Dermatomycoses: 2–8 weeks
Onychomycosis: 1–12 months
Fungal infections of hair and scalp: 1–2 months
Chronic mucocutaneous candidiasis: 1–12 months
Oral fungal infections: 5–10 days
Systemic candidiasis: 1–2 months
Paracoccidioidomycosis, histoplasmosis, and other systemic mycoses: 1 month to 2 years
Nausea, Headache, Diarrhea, abdominal pain, and vomiting may be associated with the active components of Dancel Tablet.
Contraindicated in patients with known hypersensitivity to ketoconazole.
No drug interaction in case of Shampoo and Cream. Drugs that reduce gastric acidity (eg.; acid neutralizing medicines such as aluminium hydroxide, suppressors such as H2 receptor antagonists and proton pump inhibitors) impair the absorption of Tablets.
Pregnancy & Lactation Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown reproductive toxicity. Since Ketoconazole is not absorbed through the skin after topical application, Ketoconazole 2% shampoo and cream are not contraindicated in pregnancy and lactation. Ketoconazole is excreted in the milk. Mothers who are under treatment with Dancel Tablets should not breastfeed.
In patients with a previous history of liver disease, liver enzyme levels should be monitored during treatment. When patients develop symptoms indicative of liver reaction, such as nausea or fatigue, accompanied by pale faeces, dark urine or jaundice, Dancel therapy should be stopped immediately
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
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