Properties
What is it?
International name - gentamicin, betamethasone, miconazole Clinical-pharmacological group - agents with antibacterial, antifungal, and anti-inflammatory action Composition and dosage form 20 g cream in a tube Each 100 g of cream contains: Gentamicin base (as sulfate) - 0.10 g Betamethasone 17-valerate – 0.10 g Miconazole nitrate – 2.00 g Excipients: Propylene glycol 10.00 g PW wax 8.00 g Liquid petrolatum 10.00 g Hard petrolatum 20.00 g Disodium EDTA – 0.50 g Propylparaben – 0.02 g Methylparaben 0.20 g Tween 80 – 1.00 g Purified water q.s. 100.00 g Indications Inflammatory dermatopathies caused by bacterial, fungal, and mixed infections. Secondary dermatitis caused by fungal or bacterial infection. Bacterial and fungal infections with pronounced inflammatory reaction. Dosage and administration The cream is applied to the affected area, 1 or 2 times a day, according to medical indications. Side effects Generally, Factor Dermico does not cause many side effects. If the preparation is used for more than 4 weeks on an area of the body exceeding 10% of the surface area, secondary reactions such as skin atrophy and irritation, stretch marks, itching, skin dryness, telangiectasias, and folliculitis are expected. Side effects may also be related to systemic absorption of steroids. The latter can be caused by the use of occlusive dressings for a prolonged period. Contraindications Allergy to any component of the preparation, skin tuberculosis, skin lesions caused by syphilis or viral infection (herpetic infection, including Herpes zoster). Pregnancy and lactation Observations in experimental animals have shown that high oral doses of miconazole caused fetotoxic effects, and administration of corticosteroids to pregnant animals can cause growth retardation of the embryo. Therefore, in pregnant women, this combination is used only if the benefit of using the preparation outweighs the risk associated with its use. Pediatric patients: As with other topical corticosteroids, this preparation is used with caution in children, especially when used on large areas of skin or with occlusive dressings, including diapers. The cream is also used with caution in the facial area. Prolonged use of topical corticosteroids in children is not desirable, as the preparation may cause adrenal suppression. Elderly patients: In elderly patients, there is a thinning of the natural skin cover, so the preparation is used only for a short period.