Pharmacotherapeutic group:
Corticosteroids for use in dermatology. Corticosteroids, combinations with antibiotics. Betamethasone and antibiotics. ATX code D07C C01.
Composition:
active substances: betamethasone, gentamycin;
1 g of cream contains 1 mg of betamethasone (in the form of 17-valerate) and 1 mg of gentamicin (in the form of sulfate);
Excipients: chlorocresol, sodium dihydrogen phosphate dihydrate, dilute phosphoric acid, mineral oil, cetostearyl alcohol, polyethylene glycol cetostearyl ether, white soft paraffin, sodium hydroxide, purified water.
Indications for use:
Dermatoses that can be treated with glucocorticosteroids, with complications or suspected complications of secondary infection caused by gentamicin-sensitive microorganisms: eczema (atopic, childhood, coin-like), anogenital and senile pruritus, contact dermatitis, seborrhea , exfoliative dermatitis, stasis dermatitis and psoriasis.
Contraindications:
The drug is contraindicated in patients with hypersensitivity to the active substances or to any other component of the drug.
The drug is contraindicated in tuberculosis of the skin, cutaneous manifestations of syphilis, skin reactions after vaccination, widespread plaque psoriasis, varicose veins, perioral dermatitis, pink acne, chickenpox, viral infections, other bacterial and fungal infections of the skin without fungal and fungal antibacterial infections. Interaction with other medicinal products and other forms of interaction. Due to the presence of white soft paraffin and mineral oil, the application of Celestoderm-B cream with Garamycin on the anogenital area can damage the structure of latex condoms and reduce their safety when used during treatment.
Method of administration and dosage:
The cream is applied in a thin layer on the entire affected area of skin 2 times a day – morning and evening. The frequency of application of the drug is determined by the doctor individually, depending on the severity of the disease. In mild cases, used once a day, with more severe lesions may need more frequent use. The duration of treatment depends on the size and location of the disease, as well as the patient’s response to treatment. However, if no clinical improvement is observed within 3 to 4 weeks, the diagnosis should be reconsidered.
Children.
There are no clinical data on the use of the drug in children, so it is undesirable to use it in patients of this age category. Because children have a greater ratio of surface area to body weight than adults, there is a more active absorption of the drug. Therefore, children are more prone to the development of suppression of the function of the hypothalamic-pituitary-adrenal (GGNZ) system due to the use of corticosteroids and the development of exogenous effects of corticosteroids. In children receiving topical corticosteroids, adrenal suppression, Cushing’s syndrome, growth retardation, insufficient weight gain, increased intracranial pressure were noted. Manifestations of adrenal insufficiency: low plasma cortisol levels and no response to adrenal stimulation test with adrenocorticotropic hormone (ACTH). Increased intracranial pressure is manifested by protrusion of the temporal lobe, headache, bilateral edema of the optic disc.
Overdose.
With long-term or excessive use of topical glucocorticosteroids may suppress pituitary-adrenal function with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing’s disease. A single overdose of gentamicin did not cause symptoms of overdose. Excessive or prolonged use of gentamicin can lead to overgrowth of antibiotic-insensitive microorganisms. Treatment. Apply appropriate symptomatic therapy. Symptoms of acute hypercorticism are usually reversible. If necessary, carry out the correction of electrolyte balance. In case of chronic toxicity, gradual discontinuation of corticosteroids is recommended. In case of excessive growth of resistant microorganisms, it is recommended to stop treatment with the drug and prescribe the necessary therapy.
Pharmacological properties.
Pharmacodynamics.
The drug combines long-term anti-inflammatory, antipruritic and vasoconstrictive action of betamethasone valerate with a wide range of antibacterial activity of gentamicin sulfate. Active against Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains) and gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumonia.
Pharmacokinetics.
There are no data on the pharmacokinetics of Celestoderm-B with Garamycin.
Shelf life:
3 years.
Storage conditions:
Store in a dark place and out of reach of children at a temperature not exceeding 25 ºС
Produced in Belgium
