Composition, form of production and packaging
? Cream for external use in white or almost white.
100 g
betamethasone dipropionate 64 mg,
which corresponds to the content of betamethasone 50 mg
gentamicin (in the form of sulfate) 100 mg
Auxiliary substances: methyl parahydroxybenzoate 0.2 g, propylene glycol 21.7 g, paraffin liquid 20 g, macrogol cetostearate 1.3 g, cetostearyl alcohol 5.7 mg, disodium edetate 0.5 g, sodium hydrophosphate dodecahydrate 0.1 g, potassium dihydrogen phosphate 0.9 g, purified water - up to 100 g.
15 g - aluminum tubes (1) - cardboard packs.
30 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
PHARMACHOLOGIC EFFECT
The combined preparation for external application, rendering anti-inflammatory, antiallergic and antibacterial action.
Betamethasone dipropionate - GCS, has anti-inflammatory, antiallergic, antiexudative and antipruritic effect. It inhibits the accumulation of leukocytes, the release of lysosomal enzymes and mediators of inflammation in the focus of inflammation, inhibits phagocytosis, reduces vascular-tissue permeability, prevents the formation of inflammatory edema.
Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. Has a bactericidal effect against the causative agents of primary and secondary bacterial skin infections. It is active against Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; Gram-positive bacteria: Streptococcus spp. (sensitive strains of beta and alpha-hemolytic streptococcus group A), Staphylococcus spp. (coagulase-positive, coagulase-negative and some strains producing penicillinase).
Inactive against anaerobes, fungi and viruses.
PHARMACOKINETICS
Data on the pharmacokinetics of Acriderm Genta are not available.
INDICATIONS
- dermatitis (simple and allergic), especially the secondarily infected;
- Eczema (atopic, childish, coin-like);
- Atopic dermatitis (diffuse neurodermatitis);
- simple chronic lichen (neurodermatitis limited);
- sunny dermatitis;
- exfoliative dermatitis;
- Radiation dermatitis;
- intertrigo;
- psoriasis;
- itching.
DOSING MODE
The drug is used externally.
The cream is applied a thin layer on the affected area of ​​the skin 2 times / day (morning and evening).
The multiplicity of the drug is determined based on the severity of the disease. In mild cases, the cream is sufficient to apply 1 time / day; with more severe lesions, more frequent use is possible.
The duration of treatment depends on the effectiveness and tolerability of therapy and is 2-4 weeks.
In the absence of clinical improvement, it is necessary to clarify the diagnosis.
SIDE EFFECT
Local reactions: with local application of GCS, burning, irritation, dry skin, folliculitis, hypertrichosis, acne-like eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis can be observed. With prolonged use, as well as with the use of occlusive dressings - skin maceration, secondary infection, skin atrophy, sweating, purpura.
Systemic reactions: when applied to extensive body surfaces, mainly in children, systemic side effects of GCS may occur (hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestations of Cushing's syndrome) and gentamicin (nephrotoxic and ototoxic effect).
CONTRAINDICATIONS
- Tuberculosis of the skin;
- cutaneous manifestations of syphilis;
- chickenpox;
- Herpes simplex;
- skin postvaccinal reactions;
- open wounds;
- lactation period (breastfeeding);
- Children's age up to 1 year;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Safety of topical application of SCS in pregnant women is not established. Therefore, the appointment of drugs of this group during pregnancy is possible only if the potential benefit exceeds the possible risk. If you need to use Acriderma Genta during pregnancy, do not use the drug in high doses or for a long time.
It has not been established whether betamethasone is released with topical application of Acriderma Genta, therefore, if it is necessary to use the drug during lactation, the question of stopping breastfeeding should be resolved.
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 1 year.
Children from 1 year of the drug is prescribed only for strict indications and under medical supervision, tk. possible development of systemic side effects associated with betamethasone. When applying the drug on extensive surfaces and / or occlusal to the viscous may suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, there may be a decrease in the excretion of growth hormone, an increase in intracranial pressure.
SPECIAL INSTRUCTIONS
If there are signs of increased sensitivity or skin irritation associated with the use of the drug, the treatment should be discontinued and the patient should be treated adequately.
With long-term treatment, when applying the drug on the vast surface of the skin, with the use of occlusive dressings, as well as in children, systemic absorption of GCS is possible.
On the skin of the face more often than on other surfaces of the body, after prolonged treatment of GCS for local use, atrophic changes may appear. The course of treatment in this case should not exceed 5 days.
Akriderm Genta is not intended for use in ophthalmology. Avoid contact with the eyes.
With prolonged use of the drug, it should be canceled gradually.
Use in Pediatrics
Children from 1 year of the drug is prescribed only for strict indications and under medical supervision, tk. possible development of systemic side effects associated with betamethasone. When applying the drug on extensive surfaces and / or occlusal to the viscous may suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, there may be a decrease in the excretion of growth hormone, an increase in intracranial pressure.
OVERDOSE
Acute overdose is unlikely, but with excessive or prolonged use of the drug, chronic overdose is possible, accompanied by signs of hypercorticism: hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestations of Cushing's syndrome.
Treatment: the appropriate symptomatic treatment is indicated. In the case of chronic toxic effects, a gradual withdrawal of the drug is recommended.
DRUG INTERACTION
The interaction of Acriderm Genta with other drugs has not been identified.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 2 years.
