Dermocas

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DERMOCAS

Composition:

Active substances: gentamicin in the form of sulfate, betamethasone 17-valerate, miconazole nitrate;

1 g of cream contains gentamicin in the form of sulfate 1 mg; betamethasone 17-valerate 1 mg; miconazole nitrate 20 mg;

Excipients: propylene glycol; emulsified non-ionic wax; mineral oil; paraffin; disodium edetate; propylparaben (E 216); methylparaben (E 218); polysorbates; purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: liquid white cream, free from lumps, air bubbles or foreign particles, homogeneous.

Pharmacotherapeutic group.

Corticosteroids in combination with other agents.

ATC code D07X C.

Pharmacological properties.

Pharmacodynamics.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. It exerts a bactericidal effect, providing highly effective local treatment of primary and secondary bacterial skin infections. It is active against gram-negative bacteria Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; and gram-positive bacteria Streptococcus spp. (beta- and alpha-hemolytic streptococci group A strains), Staphylococcus aureus (coagulase-positive and coagulase-negative, including some penicillinase-producing strains).

Miconazole has antifungal activity due to inhibition of ergosterol biosynthesis and alteration of membrane lipid composition, leading to fungal cell death. Miconazole exhibits antifungal activity against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeasts and yeast-like fungi (Candida albicans), as well as other pathogenic fungi (Malassezia furfur, Aspergillus niger, Penicillium crustaceum). It is also active against some gram-positive bacteria (staphylococci, streptococci).

Betamethasone is an anti-inflammatory, glucocorticoid, anti-allergic, and anti-pruritic 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, γ-interferon (from lymphocytes and macrophages), inhibits hyaluronidase activity, and decreases vascular wall permeability. It interacts with specific receptors in the cell cytoplasm, stimulates RNA synthesis, induces the formation of proteins, including lipocortin, which mediate cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and biosynthesis of endoperoxides, prostaglandins, and leukotrienes, thereby preventing the development of inflammation, allergy, and other pathological processes.

Pharmacokinetics.

When applied topically, the drug is practically not absorbed into the systemic circulation.

Clinical characteristics.

Indications.

Dermatoses amenable to treatment with glucocorticosteroids, when there is suspicion of complication or complicated by secondary infection caused by microorganisms sensitive to the components of the drug (active against gram-negative bacteria Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive bacteria Streptococcus spp. (beta- and alpha-hemolytic streptococci group A strains sensitive to the drug), *Staphylococcus aure游戏副本

Special precautions for use.

Do not apply to the facial skin. Do not use on large areas of skin (especially if skin integrity is impaired, e.g., in burns). Do not use under occlusive dressings.

Any adverse effects associated with systemic corticosteroids, including suppression of adrenal cortex function, may also occur with topical application of glucocorticosteroids, particularly in children.

Cross-allergic reactions with aminoglycosides are possible.

Prolonged topical use of antibiotics may sometimes lead to overgrowth of resistant microorganisms. In such cases, as well as in the event of irritation, sensitization, or development of superinfection during treatment, therapy should be discontinued and appropriate treatment initiated.

Avoid contact of the drug with eyes, mucous membranes, or open wounds. If local reactions occur or there is no clinical evidence of treatment efficacy within 4 weeks of using the drug, treatment should be discontinued and further examination performed. Use with caution in patients with diabetes mellitus complicated by microcirculatory disorders. When nails are affected, they should be trimmed as short as possible.

When feet are affected, special attention should be paid to treating the interdigital spaces. Wearing loose, well-ventilated footwear is recommended, and socks should be changed at least once daily. If skin irritation or signs of hypersensitivity occur, treatment with the drug should be discontinued and appropriate therapy initiated.

Systemic absorption of topical corticosteroids generally increases with higher corticosteroid dosage, longer duration of treatment, and larger treated body surface area. In such cases, appropriate precautions should be taken, as corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis. If suppression occurs, the drug should be discontinued or the frequency of application reduced, or the drug should be replaced with a corticosteroid of lower potency.

HPA axis function usually recovers after discontinuation of the drug. In some cases, withdrawal symptoms may develop, requiring administration of systemic corticosteroids.

Systemic absorption of gentamicin following topical application may be higher when treating large body surface areas, especially during prolonged use or when skin is damaged. In such cases, adverse effects related to systemic absorption of gentamicin may occur; therefore, appropriate precautions are recommended.

Use during pregnancy or breastfeeding.

The use of this drug is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Apply a thin layer to the affected skin surface twice daily (in the morning and at night). The medication should be used regularly to achieve the desired effect. The duration of treatment depends on the size and location of the lesion, as well as the patient's response to therapy.

Children.

There are no clinical data on the use of the medication in children; therefore, its use in this age group is not recommended.

Since the surface area to body weight ratio is higher in children than in adults, absorption of the medication is more pronounced. Therefore, children are more susceptible to suppression of the hypothalamic-pituitary-adrenal (HPA) axis function due to corticosteroid use, as well as to the development of exogenous corticosteroid effects.

In children receiving topical corticosteroids, adrenal suppression, Cushing's syndrome, growth retardation, inadequate weight gain, and increased intracranial pressure have been reported.

Signs of adrenal cortex function suppression include low plasma cortisol levels and lack of response to adrenal stimulation tests using adrenocorticotropic hormone (ACTH) preparations. Increased intracranial pressure may manifest as bulging of the fontanelle, headache, and bilateral optic disc swelling.

Overdose.

With prolonged or excessive use of topical glucocorticosteroids, suppression of pituitary-adrenal function may occur, leading to secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's disease.

Excessive or prolonged use of gentamicin may lead to overgrowth of antibiotic-resistant microorganisms.

Treatment is symptomatic. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended. If overgrowth of resistant microorganisms occurs, treatment with the medication should be discontinued and appropriate therapy initiated.

Skin irritation may occur, which usually resolves after discontinuation of the medication. In case of accidental ingestion of a large amount of the medication, gastric lavage is recommended. The medication is intended for external use only. Single-dose gentamicin overdose has not been associated with overdose symptoms.

Treatment. Provide appropriate symptomatic therapy. Symptoms of acute hypercortisolism are usually reversible. If necessary, correct electrolyte imbalances. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended.

Side effects

Topical use of glucocorticosteroids may cause local reactions at the application site, including skin irritation, hyperemia, burning, itching, and stinging. Other possible reactions include dryness, hypopigmentation, hypertrichosis, erythema, perioral dermatitis, allergic contact dermatitis, acneiform eruptions, follicular eruptions, telangiectasia, and sweating. Skin thickening, cracking, lamellar scaling, focal desquamation, and maceration may lead to the development of secondary infections and skin atrophy.

In addition, hypersensitivity reactions may occur, including anaphylactic reactions and angioedema.

When the drug is applied over large areas of skin, especially for prolonged periods, systemic effects should be considered. Moreover, any adverse effects associated with systemic use of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical application.

Since this product contains propylparaben (E 216) and methylparaben (E 218) as excipients, it may cause allergic reactions (possibly delayed) and, in rare cases, bronchospasm.

Shelf life

2 years.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging

10 g or 20 g of cream in an aluminum tube with a plastic cap; one tube per cardboard box.

Prescription status

Prescription only.

Manufacturer/Applicant

Laboratorios Casasco A.P.T.T./ Laboratorios Casasco S.A.I.C.

Manufacturer’s address and place of business

Boyaca No. 229/37/41/49/63/65, Terrero No. 250/52/60, Bacacay No. 1843/45 (Zip Code C1406BHC), City of Buenos Aires, Argentine Republic, and Calle 5 No. 186, Industrial Park of Pilar, Pilar District, Province of Buenos Aires, Argentine Republic.

Address of the applicant

Boyaca 237 (Zip Code C1406BHC), City of Buenos Aires, Argentine Republic / Av. Boyaca 237 (Zip Code C1406BHC), City of Buenos Aires, Argentine Republic.