Ketofung® Cream 20g (Ketoconazole 2%)

KETOFUNG® (KETOCONAZOLE 2%)
Broad spectrum Antifungal Caplets and Cream

DESCRIPTION
Ketofung® contains Ketoconazole a synthetic broadspectrum 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., sporothix schenckil, 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.

INDICATIONS
Ketofung® Caplets is indicated in infections of the skin, hair and nails induced by dermatophytes and/or yeasts (dermatophytosis, onychomycosis, candida perionyxis, pitysiais versicolor, pityriasis capitis, pityrosporum folliculitis, chronic mucocutaneous candidosis)
- Yeast infection of the gastrointestinal tract
- Chronic, recurrent vaginal candidosis, provided this infection fails to respond to local therapy
- Systemic fungal infection such as systemic candidosis, 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.

CONTRA-INDICATIONS
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, quindine, primozide are contraindicated with Ketocanazole.

WARNINGS 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.

DOSAGE AND ADMINISTRATION
For maximum absorption, Ketofung® should be taken during meals
Adults
- Skin, gastro-intestinal and systemic infections: One caplet (200mg) once daily with meal if no adequate response is obtained, the dose should be increased to 2 caplets(400mg) once daily.
- Vaginal candidosis: Two caplets (400mg) once daily with meals

Children
- Children weighing from 15 to 30kg: ½ caplet(100mg) once daily with meal
- Children weighing more than 30kg: same as for adults.

The dosage scheme should be continued without any interruption until at least one week after al the symptoms must have disappeared and until all cultures turn out to be negative. The usual duration of treatment is:
- Vaginal Candidosis: 5days
- 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 candidosis and tinea versiclor. For sebborrhoeic 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.

STORAGE CONDITIONS
Store below 30ºC. The caplets must be stored in a dry place, protect from light.

PRESENTATION
Ketofung® is available in caplets containing 200mg of Ketoconazole supplied in blister pack and as 2% cream in 20g tube.

Manufactured by:
DRUGFILED PHARMACEUTICALS LIMITED
Lynson Chemical Avenue,
Km 38 Lagos-Abeokuta Expressway,
Sango-Otta, Nigeria