DAKTARIN ORAL GEL 2%

Indications

Treatment of candidosis of the oropharyngeal cavity in adults and pediatric patients 4 months and older (see Contraindications and Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

DAKTARIN® Oral Gel is contraindicated in the following situations:

• In patients with hypersensitivity to miconazole, or to any of the excipients, or other imidazole derivatives.

• In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed.

• In patients with liver dysfunction.

• Use in combination with the following drugs that are subject to metabolism by CYP3A4: (See Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

  • Substrates known to prolong the QT-interval for example, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine
  • Ergot alkaloids
  • HMG-CoA reductase inhibitors such as simvastatin and lovastatin
  • Triazolam and oral midazolam.

• Use of miconazole oral gel in combination with the following drug that is subject to metabolism by CYP2C9 (See Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

  • Warfarin

Dosage and Administration

Oral Gel

5 mL (one measuring spoonful) of gel is equivalent to 124 mg miconazole.

Oropharyngeal candidosis

Infants: 4–24 months: 1.25 mL (1/4 measuring spoon) of gel, applied four times a day after meal. Each dose is to be divided into smaller portions and the gel should be applied to the affected area(s) with a clean finger. The gel is not to be swallowed immediately, but kept in the mouth as long as possible.

Adults and children 2 years of age and older: 2.5 mL (1/2 measuring spoon) of gel, applied four times a day after meals. The gel is not to be swallowed immediately, but kept in the mouth as long as possible.

Continue the treatment for at least a week after the symptoms have disappeared.

For oral candidosis, dental prostheses are to be removed at night and brushed with the gel.