Daktarin Oral Gel 80 Gr

Therapeutic indications
Daktarin Oral Gel is used in the curative and prophylactic treatment of candidiasis of the oropharyngeal cavity and gastrointestinal tract and as a therapeutic or prophylactic measure against other mycoses of the digestive tract, or against systemic mycoses, such as candidiasis, South American blastomycosis and coccidioidomycosis.

Dosage and method of use
Daktarin Oral Gel is applied in the following ways:

Candidiasis of the oropharyngeal cavity

Infants (4-24 months): 1.25 ml of gel (1/4 measuring spoon) to be applied four times a day after meals. Each dose should be divided into smaller portions and the gel should be applied to the infected area with a clean finger. The gel should not be applied to the throat due to possible choking. The gel should not be swallowed immediately, but should be kept in the mouth as long as possible.
Adults and children over 2 years of age: 2.5 ml of gel (1/2 scoop) to be applied four times a day after meals. The gel should not be swallowed immediately, but should be kept in the mouth as long as possible. Continue treatment for at least one week after symptoms disappear. In the case of oral candidiasis, remove the dentures for the night and brush them with the gel.

Candidiasis of the gastrointestinal tract
The gel can be used for infants (≥ 4 months of age), children and adults. The dose is 20 mg / kg of body weight per day, given in four divided doses. The daily dose should not exceed 250 mg (10 ml of oral gel) four times a day. Continue treatment for at least one week after symptoms disappear.

Contraindications
Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients
In infants less than 4 months of age or in whom swallowing is not yet sufficiently developed
In patients with hepatic dysfunction
In patients concomitantly receiving drugs metabolised by the CYP3A4 enzyme system, i.e.: QT-prolonging substances (astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine), ergot inhibitors of HMG-CoA reductase such as oral simvastatin and lovastatin, triazolam and midazolam.

Special warnings
In case of concomitant use of Daktarin and oral anticoagulant drugs, such as warfarin, the anticoagulant effect should be carefully monitored and titrated. It is advisable to check the levels of miconazole and phenytoin, in case of concomitant intake of the two drugs. In patients being treated with certain oral hypoglycaemics, such as sulfonylureas, an increased therapeutic effect may occur which can lead to hypoglycaemia if they take miconazole at the same time. Therefore, appropriate precautions must be taken.

It is important to take into account the variability of swallowing development in infants, particularly when oral miconazole gel is administered to infants aged 4-6 months. The lower age limit should be raised to 5-6 months of age for infants born prematurely or whose swallowing is not yet sufficiently developed.

Pregnancy and breastfeeding

Pregnancy

In animal studies, miconazole did not demonstrate teratogenic effects, but foetotoxic effects at high oral doses. The significance of this correlation in humans is unknown. It is preferable to avoid the use of Daktarin during pregnancy unless the benefits of therapy for the patient are considered to be greater
with respect to the risks to the fetus.

Feeding time

It is not known whether miconazole or its metabolites are excreted in human milk, therefore caution should be exercised when prescribing Daktarin during breastfeeding.

Expiry and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 25 ° C.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition
Daktarin Oral Gel contains:
Active ingredient: miconazole 20 mg
Excipients: Polysorbitan monolaurate, sodium saccharin, purified water, pregelatinized potato starch, orange flavor, cocoa flavor, ethyl alcohol, glycerin

Daktarin Oral Gel in packs of 80 grams