(KETOCONAZOLE 200mg caplet, 2% cream)
Broad spectrum Antifungal Caplets and Cream
Ketofung® contains Ketoconazole a synthetic broad-spectrum antifungal agent available as Caplets and Cream. Each Caplet contains 200mg Ketoconazole, while 1gm of Cream contains 20mg Ketoconazole.
Ketoconazole is a synthetic imidazole with a fungicidal or fungistatic activity against dermatophytes, yeasts, dimorphic fungi and eumycetes. Less sensitive are: Aspergillus spp., Sporothrix schenckii, some dermatiaceas, Mucor spp. and other phycomycetes except entomophthorales.
Ketoconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane.
Ketofung® Caplets is indicated in infections of the skin, hair and nails induced by dermatophytes and / or yeasts(dermatophytosis, onychomycosis, Candida perrionyxis, pityriasis versicolor, pityriasis capitis, pityrosporum folliculitis, chronic mucocutaneous candidiasis),
- Yeast infection of the gastrointestinal tract.
- Chronic, recurrent vaginal candidiasis provided this infection fails to respond to local therapy.
- Systemic fungal infections such as systemic candidiasis, paracoccidiodomycosis histoplasmosis, coccidiodomycosis, blastomycosis.
- Prophylactic treatment of patients with decreased defense mechanisms (inherited, caused by illness or drugs), involving an increased risk of fungal infections.
Ketofung® does not penetrate well in the CNS, therefore, fungal meningitis should not be treated with oral Ketoconazole.
Patients with acute or chronic liver disease or with a known hypersensitivity to the drug or its components should not be treated with Ketofung®. Terfenadine, astemizole, cisapride, triazolam, oral midazolam, quinidine, pimoxide are contraindicated with Ketoconazole.
WARNING AND PRECAUTIONS
Decreased gastric acidity. Absorption is impaired when the gastric acidity is decreased in patients receiving acid neutralizing medicines (e.g. Aluminium Hydroxide), they should be administered at least 2 hours after the intake of Ketofung®
Liver function tests should accompany Ketofung® treatment which last longer than 2 weeks; before treatment, after 2 weeks and later on monthly.
KEEP OUT OF THE REACH OF CHILDREN
PREGNANCY AND LACTATION
No studies are available on its use in pregnant women; therefore, Ketofung® may not be administered during pregnancy, unless the potential advantage justifies the possible risk to the foetus. Since Ketofung® is excreted in the milk; mothers who are under treatment should not breastfeed.
For maximum absorption, Ketofung® Caplets should be taken during meals
- Skin, gastro-intestinal and systemic infections: One Caplet (200mg) daily with meal. If no adequate response is obtained, the dose should be increased to 2 caplets (400mg) once daily.
- Vaginal candidiasis: Two caplets (400mg) once daily with meals.
- Children weighing from 15 to 30 kg: ½ caplet (100mg) once daily with meals.
- Children weighing more than 30kg: Same as of adults.
The dosage scheme should be continued without any interruption until at least one week after all the symptoms must have disappeared and until all cultures turn out to be negative.
The usual duration of treatment is:
- Vaginal Candidiasis: 5 days
- Skin Mycoses induced by dermatophytes: 4 weeks
- Pityriasis versicolor: 10 days
- Oral and skin mycosis induced by candida: 2 – 3 weeks
- Hair infection: 1-2 months
- Nail infection: 6-12 months
Ketofung® Cream should be applied to the affected area once daily in patients with Tinea corporis, Tinea cruris, Tinea manus, Tinea pedis, Cutaneous candidiasis and Tinea versicolor.
For seborrhoeic dermatitis, Ketofung® cream should be applied to the affected area once or twice daily depending on the severity of the infection.
Treatment should be continued until a few days after disappearance of all symptoms.
Ketofung® is available in caplets containing 200mg of ketoconazole supplied in blister pack of 3 x 10 and as 2% cream in 20g Tube.
Store below 300C. Protect from light and moisture.