Supirotsin-B
Producer: Glenmark Pharmaceuticals Ltd. (Glenmark Pharmasyyutikalz Ltd) India
Code of automatic telephone exchange: D07CC01
Release form: Soft dosage forms. Ointment.
General characteristics. Structure:
Active agents: мупироцин – 2 g, betamethasone Dipropionas equivalent to betamethasone – 0,05g.
Excipients: macrogoal 400 (polyethyleneglycol 400), macrogoal 4000 (polyethyleneglycol 4000).
Pharmacological properties:
The combined drug for external use which action is caused by the components which are its part.
Mupirotsin - the antibiotic produced by Pseudomonas fluorescens microorganism. Mupirotsin suppresses synthesis of protein of a bacterial cell by means of reversible linkng with an izoleytsil-transport RNK-sintetazoy that prevents inclusion of an isoleucine in proteinaceous chains under construction. When using in the minimum inhibiting concentration мупироцин possesses bacteriostatic, and in higher concentration - bactericidal action.
Thanks to the specific mechanism of action and unique chemical structure, cross resistance with other antibiotics is absent.
At the correct use of a mupirotsin risk of emergence of resistant strains of microorganisms small.
Betamethasone - a glucocorticosteroid for external use.
Renders antiinflammatory local, antiallergic, antiedematous and anti-proliferative action. Possesses stronger vasopressor action, than other ftorproizvodny glucocorticosteroids; system effects are expressed slightly because of limited absorption through integuments. At impact on skin there is prevention of regional accumulation of neutrophils that leads to reduction of exudation, products of cytokines, macrophage fixation, leading finally to reduction of processes of infiltration and granulation.
Pharmacokinetics. Mupirotsin practically does not get through the unimpaired integuments. In case of adsorption through the injured skin it is metabolized to microbiological inactive metabolite - moniyevy acid and quickly removed by kidneys.
Betamethasone Dipropionas is lipophilic substance and is easily soaked up through a corneous layer of skin, without being exposed to biotransformation. Absorption increases when drawing by skin in the field of body folds, by skin with the injured epidermis or by area of an inflammation, at frequent use of drug or after drawing on the considerable surface of skin. Dipropionas betamethasone absorption through skin at children happens quicker, than at adults.
Indications to use:
It is applied to treatment of atopic dermatitis, diffusion neurodermatitis, contact dermatitis (simple and allergic), the exfoliative dermatitis, a small tortoiseshell, herpetiform dermatitis, seborrheal dermatitis, eczema, psoriasis complicated by consecutive bacterial infections.
Route of administration and doses:
The recommended dosage: to apply ointment a thin layer on the struck place 2-3 times a day within 5-14 days. To apply only to processing of the struck places having length no more than 10 cm or the area - no more than 100 cm2. If within 3-5 days at patients clinical reaction is not observed, they need to be inspected repeatedly.
Features of use:
To avoid hit of ointment in eyes, on mucous membranes, and also on open wounds and burns. As well as in a case with other antibacterial substances, prolonged use of ointment can lead to the overgrowth of organisms, including mushrooms, unreceptive to its action.
Considering existence in composition of drug of a strong glucocorticosteroid, drug needs to be used in the acute period of a disease, quickly, on the insignificant surface of skin.
It is not necessary to use drug on face skin in connection with a possibility of emergence of teleangiectasias, perioral dermatitis. On skin in axillary and inguinal area drug should be used only in emergency cases.
It is not necessary to use drug under an occlusive bandage since it can lead to an epidermis atrophy, emergence of striya, development of superinfection.
Side effects:
Burning, itch, irritation, xeroderma, folliculitis, hypertrichosis, acneform rashes, hypopigmentation, circumoral dermatitis, allergic contact dermatitis, maceration of skin, consecutive infection, skin atrophy, heat rash.
Interaction with other medicines:
Interaction with other medicines is not revealed.
Contraindications:
Hypersensitivity; the skin displays of syphilis, a tuberculosis cutis, bacterial, viral, fungus skin diseases, trophic ulcers of a shin connected with a varicosity, a carcinoma cutaneum, a nevus, an atheroma, a melanoma, a hemangioma, a xanthoma, sarcoma, a rozatsea, vulgar eels, postvaccinal skin reactions, the period of pregnancy and breastfeeding, children's age up to 12 years.
With care
The macrogoal (polyethyleneglycol) can be soaked up through a wound surface or through other damages of integuments and be removed by kidneys.
Ointments on the basis of a macrogoal cannot be applied on extensive surfaces at the states which are followed raised by polyethyleneglycol absorption, and especially at a moderate and heavy renal failure.
For patients with a diabetes mellitus, glaucoma, tuberculosis, a cataract prolonged use of ointment on extensive sites of skin is not recommended.
With care it is necessary to apply at an atrophy of hypodermic cellulose, especially at elderly people.
Pregnancy and lactation
Drug is contraindicated to use at pregnancy and in the period of a lactation (breastfeeding).
Overdose:
Symptoms: reversible oppression гипоталамо - pituitary and adrenal system, manifestation of a syndrome of Cushing, a hyperglycemia, a glucosuria. Treatment: symptomatic
Storage conditions:
In the dry, protected from light place at a temperature not above 25 °C.
Not to freeze.
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
Ointment for external use.
On 5 g in the aluminum tubas from within varnished by latex, having a nozzle with the closed end with the cover having an edge for piercing.
One tuba together with the application instruction is located in a cardboard pack.