KENAZOL (Tablets)
Broad Spectrum Antifungal

Composition:
Each tablet contains 200mg Ketoconazole.

Indications:
KENAZOL tablets is a broad spectrum antifungal indicated for treatment of:

  • Systematic fungal infections.
  • Fungal mucocutaneous candidiasis.
  • Infection of gastrointestinal tract & vaginal candidacies fungal infection, which are not responsive to local treatment.
  • Prophylactic treatment in decreased auto-immunity patients in cancer & during treatment with immune suppressive medications.
  • Fungal infections of calcified parts like nails, or hair, which are not responsive to treatment of Griseofulvin.

Dosage:
Adults:

  • In fungal infections (except mycotic vaginal infection): One tablet daily with a meal for 14 days.

Treatment can be continued for another week, if an adequate response has not been achieved after 14 days. Dose has to be increased to one tablet twice daily.

  • Chronic vaginal candidiasis: one tablet twice daily with a meal for 5 days.

Children:
The dose is weight dependent and it is about 3mg/kg or as follows:
1 – 4   years: 50mg daily.
5 – 12 years: 100mg daily.

Contraindications:
Hypersensitivity to Ketoconazole, as in rare cases, anaphylactic shock has been reported after first dose. Or in patients with hepatic disorders.

Side Effects:
Change in hepatic function may occur and this change may be transient. Cases of hepatitis have been reported and in this case treatment should be stopped, especially in long termed treatment (more than 14 days). These changes may disappear after treatment stopping.
The most common side effects are: nausea, vomiting, abdominal pain, rash, urticaria, pruritus and headache.

Drug Interactions:
The absorption of KENAZOL tablets is maximum when taken during a meal as it depends on stomach acidity. Concomitant treatment with compounds reducing gastric secretion (e.g. antacids, anticholinergic drugs, H2-receptors blockers, antibiotics like cyclosporin and rifampicin, and oral anticoagulant drugs) should be avoided. If necessary, such drugs should be taken after two hours from taking KENAZOL tablets.
Ketoconazole is extensively bound to plasma proteins. It may enhance the anticoagulant effect of coumarin-like drugs. The dose should be carefully monitored in combined treatment.
Rifampicin and phenytoin reduce the anti-fungal effects of Kenazol tablets, therefore care should be taken in case of concomitant treatment with these two drugs.

precautions:
Test should be carried out to determine the hepatic function before starting treatment. It should be repeated every month during long termed treatment.

Before starting treatment and during it, transaminase and alkaline phosphate should be monitored.

Use in Pregnancy or Lactation:
It should not be administered during pregnancy and not advisable to breast feed while being treated with.

Presentation:
Carton pack containing one blister of 10 tablets, and a leaflet.

 

 

 
 
 

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