Crocsiderm cream 15g

Form

kremi

Pack

1

International Nonproprietary Name or Group Name: Betamethasone + Clotrimazole + Gentamicin Dosage Form: Cream for external use. Description: Homogeneous cream of white or almost white color, without foreign particles and odor. Composition: 1 g of cream contains active substances: Betamethasone (in the form of betamethasone dipropionate) 0.5 mg, Clotrimazole 10 mg, Gentamicin sulfate 1 mg. Excipients: White soft paraffin, Liquid light paraffin, Cetostearyl alcohol, Macrogol cetostearyl ether, Propylene glycol, Benzyl alcohol, Sodium dihydrogen phosphate dihydrate, Purified water. ATC code of the preparation: D07XC01 Pharmacotherapeutic group: Active corticosteroids in combination with other drugs. Pharmacological properties: Pharmacodynamics: Croxiderm is a combined preparation for external use, which combines the anti-inflammatory, antipruritic, and vasoconstrictive action of betamethasone dipropionate with the broad-spectrum antifungal action of clotrimazole and the broad-spectrum antibacterial activity of gentamicin sulfate. Clotrimazole has an antifungal effect by disrupting the synthesis of ergosterol, which is a component of the fungal cell membrane. It is active against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida (including Candida albicans), Malassezia furtur (Pityrosporum orbiculare). Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. It acts bactericidally and provides highly effective topical treatment of primary and secondary bacterial skin infections. It is active against Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae; and Gram-positive bacteria: Streptococcus spp. (sensitive strains of beta- and alpha-hemolytic streptococci of group A), Staphylococcus aureus (some strains coagulase-positive, coagulase-negative, and penicillinase-producing). Pharmacokinetics: No data on the pharmacokinetics of the preparation are available. Indications: Dermatoses complicated by infections caused by pathogens sensitive to the drug or in case of suspicion of similar infections, including - simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema (including wet form of eczema), dermatomycoses (dermatophytosis, candidiasis, pityriasis versicolor), especially when localized in the groin area and large skin folds; simple chronic lichen (limited neurodermatitis). Method of administration and dosage: For external use. Apply Croxiderm cream in a thin layer to the entire affected skin surface and surrounding tissues twice a day - morning and night. To ensure the effectiveness of treatment, Croxiderm cream should be used regularly. The duration of therapy depends on the size and localization of the lesion, as well as the patient's response. If clinical improvement does not occur after 3-4 weeks of treatment, this may be a reason to clarify the diagnosis. Contraindications: - Hypersensitivity to any component of the preparation; - Cutaneous tuberculosis; - Cutaneous manifestations of syphilis; - Chickenpox; - Herpes simplex; - Post-vaccination skin reactions; - Open wounds; - Age up to 2 years. Adverse reactions: With the use of this combination, very rarely observed: burning sensation, erythema, exudation, pigmentation disorder, and itching. Adverse reactions that occur with the use of topical glucocorticosteroids (especially with occlusive dressings): irritation, burning sensation, itching, skin dryness, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, development of secondary infection, skin atrophy, striae, rash. Adverse reactions caused by clotrimazole: erythema, tingling sensation, blistering, peeling, local edema, itching, urticaria, skin irritation. Adverse reactions caused by gentamicin: transient skin irritation (erythema, itching), usually does not require discontinuation of treatment. Special instructions: Croxiderm is not intended for ophthalmic use. If irritation or hypersensitivity occurs during the use of the preparation, treatment should be discontinued. Prolonged use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as in case of irritation, sensitization, or development of superinfection, against the background of Croxiderm treatment, treatment should be discontinued and appropriate therapy should be prescribed. Cross-allergic reactions with aminoglycoside antibiotics have been identified. Any adverse reactions that occur with the use of systemic glucocorticosteroids, including suppression of adrenal cortex function, may also occur with topical use of glucocorticosteroids, especially in children. Systemic absorption of glucocorticosteroids or gentamicin during topical use will be higher if treatment is carried out on large areas of skin or with the use of occlusive dressings, especially during prolonged treatment or with impaired skin integrity. Avoid applying gentamicin to open wounds and damaged skin. Otherwise, systemic adverse reactions characteristic of gentamicin may occur. In such cases, appropriate precautions should be taken, especially when treating children. With prolonged use of the preparation, gradual withdrawal is recommended. Effect on ability to drive and operate machinery: The effect of Croxiderm on the ability to drive vehicles and operate machinery has not been identified. Use during pregnancy and lactation: Since the safety of topical corticosteroids in pregnant women has not been studied, the use of drugs of this class is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. Drugs of this class should not be widely used in pregnant women. in large quantities or for a long time. Since it is not known whether topical application of corticosteroids can cause sufficient systemic absorption to be excreted in breast milk, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug for the mother. Use in pediatrics: Children may be more sensitive to topical corticosteroids that cause hypothalamic-pituitary-adrenal axis suppression and exogenous corticosteroid effects than adult patients, due to increased absorption at the expense of increased skin surface area to body weight ratio. In children receiving topical corticosteroids, hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, growth retardation, delayed weight gain, and increased intracranial pressure may occur. Manifestations of adrenal suppression in children include low plasma cortisol levels and lack of response to adrenocorticotropic hormone stimulation. Manifestations of increased intracranial pressure include bulging fontanelle, headache, and bilateral papilledema. Interaction with other drugs: No drug interactions have been identified. Overdose: Symptoms: Prolonged use of topical glucocorticosteroids in high doses can lead to suppression of adrenal function with the development of symptoms of secondary adrenal insufficiency and hypercorticism, including Cushing's syndrome. Overdose of clotrimazole with topical use is unlikely. No symptoms are expected with a single overdose of gentamicin. Prolonged treatment with gentamicin at increased doses may lead to the growth of resistant flora. Treatment: Symptomatic. Acute symptoms of hypercorticism are usually reversible. Correction of electrolyte imbalance should be carried out if necessary. In case of chronic toxicity of glucocorticosteroids, gradual withdrawal of glucocorticosteroids is recommended. Dosage form: 15 g of cream for external use in an aluminum tube with an epoxy coating, sealed with a membrane and a screw-on polypropylene cap. 1 tube together with the instructions for medical use in a cardboard box. Storage conditions: Store at a temperature not exceeding 25°C. Keep out of reach of children! Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Conditions of dispensing from pharmacies: Pharmaceutical product group - III, dispensed without a prescription. Manufacturer: "World Medicine İlaç San. ve Tic. A.Ş.", Turkey (15 Temmuz Mah. Cami Yolu Cad. No:50 Güneşli Bağcılar / İstanbul)