Micazole oral gel

Trade Name:

Micazole oral gel

Composition

Each gram of oral gel contains:

Miconazole 20 mg

Inactive ingredients:

Carbopol, propylene glycol, ethanol 96%, glycerin, sodium saccharin, strawberry flavor, sodium hydroxide, PEG, PVP, sorbitol 70% solution, ethyl maltol, ponceau, purified water.

Properties

Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition on the ergosterol biosynthesis in fungi and the change in the composition of the liquid components in the membrane, resulting in fungal cell necrosis.

Properties

PIDICATIONS:

Oral treatnert and prevention of fungal infections of fhe oropharynx and gastrointestinal tract, and of super infections due to Grarr-positve bacteria.

Dosage and application:

Contraindications

Known hypersensitivity to miconazole or to any of the excipients.

In Infants less than 4 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, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine -Ergot alkaloids — HMG-CoA reductase inhibitors such as simvastatin and lovastatin, triazolam and oral midazolam.

Side effects

Common (21 /100 to < 1/10): Dry mouth, Nausea, Oral discomfort, vomiting, regurgitation and product taste abnormal.

Uncommon (z 1 /1000 to <1/100 ): Dysgeusia.

Frequency not Known: Anaphylactic reaction, angioedema, hypersensitivity, diarrhea, stomatitis, tongue discoloration, hepatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria and rash.

Storage

Store at a temperature not exceeding 30°C.

Package:

Carton box containing tubes of 20 g or 40 g gel and insert leaflet.