Dosage form
Dosage form: Cream.
Dosage form: 20 mg tubes, 1 tube per cardboard box.
INGREDIENTS:
100 g of cream contains: gentamicin sulfate 0.10 g, betamethasone 17-valerate 0.10 g, miconazole nitrate 2.00 g.
Excipients: propylene glycol 10.00 g, wax 8.00 g, liquid petrolatum 10.00 g, solid petrolatum 20.00 g, disodium EDTA 0.50 g, propylparaben 0.02 g, methylparaben 0.20 g, Tween 80 1.00 g, purified water 100.00 g.
Pharmacological action
Gentamicin is an aminoglycoside antibiotic. It is effective against susceptible strains of Streptococcus aureus (group A alpha and beta hemolytic), Staphylococcus aureus (coagulase-positive and coagulase-negative), as well as some penicillinase-producing strains and gram-negative bacteria: Pseudomonas aeruginosa, Aerobacteria aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiellapneumoniae. It binds to the 30S ribosomal subunit and disrupts protein synthesis, preventing the formation of a complex of transfer and messenger RNA (bacteriostasis). At high concentrations, it reduces the barrier function of cytoplasmic membranes and causes the death of microorganisms. Gentamicin is absorbed slowly through the skin when applied as an ointment and rapidly when applied as a cream.
Miconazole is an imidazole antifungal agent. It is active against most Candida species, Aspergillus species, Dimorphonuclear fungi, Crytococcus neoformans, Pityrosporum species, and Torulopsis glabrata. Miconazole inhibits ergosterol biosynthesis and alters the lipid composition of the membrane, causing fungal cell death. It is also active against some gram-positive microorganisms. It rapidly penetrates the stratum corneum and remains there for 4 days after application. Less than 1% is absorbed into the bloodstream.
Betamethasone is an anti-inflammatory, glucocorticoid, antiallergic, and antipruritic agent. When applied topically, it constricts blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, and gamma interferon (from lymphocytes and macrophages), inhibits hyaluronidase activity, and reduces vascular permeability. It interacts with specific receptors in the cell cytoplasm, stimulating the synthesis of mRNA that induces the formation of proteins, including lipocortin, which mediate cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, progesterone, and leukotrienes (which contribute to the development of inflammation, allergies, and other pathological processes).
Side effects
Topical glucocorticoid use may cause:
- burning;
- itching;
- rash;
- dryness;
- folliculitis;
- hypertrichosis;
- acne-like rash;
- hypopigmentation;
- perioral dermatitis;
- allergic contact dermatitis;
- skin maceration;
- secondary infection;
- skin atrophy;
- striae;
- miliaria.
Special conditions
If irritation or signs of skin hypersensitivity occur due to the use of the product, discontinue treatment and prescribe appropriate therapy.
FACTOR DERMICO cream is not recommended for the treatment of perioral dermatitis. Application of the cream around the eyes is not recommended.
Indications
Neurodermatitis, dermatitis (simple, exfoliative, solar, seborrheic, radiation, bullous herpetiformis, contact, atopic, lower extremity due to circulatory failure, etc.).
Eczema (infantile, atopic, nummular).
Psoriasis, intertrigo (diaper rash).
Pyodermatitis.
Impetigo.
Pityriasis versicolor.
Candidiasis.
Typhoid arthritis.
Vulvitis.
Balanoposthitis.
Dermatophytes.
Onychomycosis.
Alopecia areata.
Colloid scars.
Hyde's prurigo nodularis.
Pruritus (senile, anogenital).
Erythema multiforme exudative.
Erythroderma.
Pemphigus.
Mycosis fungoides and other skin diseases.
Contraindications
The drug is contraindicated in patients with a history of hypersensitivity reactions to any of the components.
Special storage conditions
Store out of reach of children at a temperature of 15-30°C.
SHELF LIFE:
24 months from date of manufacture.
Dosage
Apply a thin layer to the affected skin area twice a day – morning and night.
During pregnancy and breastfeeding
Use is only possible if the expected benefit to the mother outweighs the potential risk to the fetus or child.