Miconazole Mouth Gel

Products

Miconazole has been approved in many countries since 1981 in the form of an oral gel (Daktarin Oral Gel).

Structure and properties

Miconazole (C18H14Cl4N2O, Mr = 416.1 g/mol) is an imidazole derivative. It exists in the gel as a base.

Effects

Miconazole (ATC A01AB09) has antifungal properties against yeasts (Candida), dermatophytes, and other fungi. The effects are due to inhibition of the enzyme lanosterol-14α-demethylase in the fungi. This inhibits the synthesis of ergosterol, which leads to the accumulation of precursors and disruption of the structure of the cell membrane of the fungi. Miconazole acts not only locally in the intestine, but is also absorbed into the organism. Its bioavailability is up to 30%.

Indications

For the treatment of an oral thrush as well as candidamycosis in the digestive tract.

Dosage

According to the professional information. The gel is usually administered four times daily after meals. It should be spread on the oral mucosa to treat oral thrush and kept in the mouth as long as possible before swallowing. In infants and young children under two years of age, the dose must be divided into several doses so that the drug does not block the throat. Do not apply to the back of the throat.

Contraindications

  • Hypersensitivity
  • Infants under 4 months
  • Infants in whom the swallowing reflex is not sufficiently developed (even over 4 months).
  • Liver dysfunction
  • Combination with certain CYP3A4 substrates.

Full precautions can be found in the drug label.

Interactions

Miconazole is an inhibitor of CYP3A and CYP2C9. Consequently, the concentration of drugs metabolized by these enzymes may be increased, increasing the risk for adverse effects. According to the SmPC, the oral gel must not be co-administered with CYP3A4 substrates with a narrow therapeutic range. CYP2C9 substrates must be combined only with caution. Alcohol should be avoided during treatment.

Adverse effects

The most common potential adverse effects include taste disturbance, nausea, vomiting, an unpleasant mouth sensation, and dry mouth.