Presentation and Status in Health Basket
Infants: 6-24 months: 1.25 mL (1/4 measuring spoon) of gel, applied four times a day after meals. Each dose should be divided into smaller portions and the gel should be applied to the affected area(s) with a clean finger. The gel should not be applied to the back of the throat due to possible choking. The gel should not 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 should not 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.
Gastrointestinal tract candidosis: The gel may be used for infants (≥ 6 months of age), children, and adults who have difficulty swallowing tablets. The dosage is 20 mg per kg body weight per day, administered in 4 divided doses. The daily dose should not exceed 250 mg (10 mL Oral Gel) four times a day. Continue the treatment for at least a week after the symptoms have disappeared. Provided measuring spoon is equivalent to 124 mg per 5 mL.
Oral mycosis (thrush) and fungal infections of the upper gastrointestinal tract. It can be used for the prevention of oral thrush in patients receiving long-term treatment with antibiotics, steroids, cytotoxic and radiation therapy.
In patients with a known hypersensitivity to miconazole, another ingredient of the formulation, or other imidazole derivatives; In infants less than 6 months of age or in those whose swallowing reflex is not yet sufficiently developed; In patients with liver dysfunction; Coadministration of the following drugs that are subject to metabolism by CYP3A4:: Substrates known to prolong the QT-interval e.g., 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.
If the concomitant use of this product and oral anticoagulants such as warafrin is envisaged, the anticoagulant effect should be carefully monitored and titrated. It is advisable to monitor miconazole and phenytoin levels, if these 2 drugs are used In patients using certain oral hypoglycemics such as sulfonylureas, an enhanced therapeutic effect leading to hypoglycemia may occur during concomitant treatment with miconazole and appropriate measures should be considered.
Choking in infants and young children: Particularly in infants and young children (aged 6 months to 2 years), caution is required, to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat . Each dose should be divided into smaller portions and applied into the mouth with a clean finger. Observe the patient for possible choking.Also due to the risk of choking, the gel must not be applied to the nipple of a breast-feeding woman for administration to an infant. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.
Important notes: Contains alcohol 7.59 mg/gr. Do not use the preparation beyond 3 months from opening.
For full details see prescribing information.
The safety of this product was evaluated in 88 adult patients with oral candidiasis or oral mycoses who participated in one randomised, active-controlled, double-blind clinical trial and three open-label clinical trials. These patients took at least one dose of this product and provided safety data. The safety of this product was evaluated in 23 paediatric patients with oral candidiasis who participated in one randomised, active-controlled, open-label clinical trial in paediatric patients aged ≤1 month to 10.7 years. These patients took at least one dose of this product and provided safety data.
For full details see prescribing information.
When using any concomitant medication the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects. Oral miconazole is contraindicated with the coadministration of the following drugs that are subject to metabolism by CYP3A4: Substrates known to prolong the QT-interval e.g., 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. When coadministered with oral miconazole the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse effects. If necessary, their dosage should be reduced and, where appropriate, plasma levels monitored:
Drugs subject to metabolism by CYP2C9: Oral anticoagulants such as warfarin, Oral hypoglycemics such as sulfonylureas, Phenytoin.
Other drugs subject to metabolism by CYP3A4: HIV protease inhibitors such as saquinavir, Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel, Certain calcium channel blockers such as dihydropyridines and verapamil, Certain immunosuppressive agents: cyclosporine, tacrolimus, sirolimus (rapamycin).
Others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil, and trimetrexate.
Pregnancy and Lactation
Pregnancy: In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The potential hazards should be balanced against the possible benefits. For full details see prescribing information.
Lactation: It is not known whether miconazole is excreted in human milk. Caution should be exercised when prescribing this product to nursing mothers.
Symptoms and signs: In the event of accidental overdose, vomiting and diarrhoea may occur.
Treatment: Treatment is symptomatic and supportive. A specific antidote is not available. In the event of accidental ingestion of large quantities an appropriate method of gastric emptying may be used, if considered necessary.