Regulatory Information
JOHNSON & JOHNSON PTE. LTD.
JOHNSON & JOHNSON PTE. LTD.
Therapeutic
General Sale List
Formulation Information
GEL
**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.
SUBMUCOSAL
Medical Information
**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
A01AB09
miconazole
Manufacturer Information
JOHNSON & JOHNSON PTE. LTD.
JANSSEN PHARMACEUTICA NV