2010/09/17

Akriderm Genta

Composition, structure and packing

The cream for external use of white or nearly white.

1 g of betamethasone dipropionate 640 mcg gentamicin sulfate, 1 mg.

Excipients: nipagin, propylene glycol, vaseline oil, macrogol tsetostearilovy ether, tsetostearilovy alcohol, disodium salt of ethylenediaminetetraacetic acid, disodium phosphate, sodium, potassium phosphate monobasic, purified water.

Clinico-pharmacological group: The product with antibacterial and anti-inflammatory properties for outdoor use.

Pharmacological action

Combined preparation for external use, anti-inflammatory, antiallergic and antibacterial properties.

Betamethasone dipropionate - SCS has anti-inflammatory, antiallergic, antiexudative and antipruritic effect. Hinders the accumulation of leukocytes, release of lysosomal enzymes and inflammatory mediators in inflammation, inhibits phagocytosis, reduces vascular tissue permeability, prevents the formation of inflammatory edema.

Gentamicin - broad-spectrum antibiotic of the aminoglycoside. Has bactericidal activity against pathogens of primary and secondary bacterial infections of the skin. 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 of penicillinase-producing).

Inactive against anaerobic bacteria, fungi and viruses.

Pharmacokinetics

Data on the pharmacokinetics Akriderm Ghent is not available.

Statement
dermatitis (simple and allergic), especially the second positive;
eczema (atopic, children, coin);
atopic dermatitis (neurodermatitis diffuse);
simple chronic zoster (neurodermatitis limited);
solar dermatitis;
exfoliative dermatitis;
radiation dermatitis;
intertrigo;
psoriasis
itching.

Dosage regimen

The drug is used externally. The cream is applied a thin layer to affected skin 2 times daily (morning and evening). Multiplicity of the drug is established based on the severity of the disease.

In mild cases the cream is enough to apply 1 time / day, with more severe lesions may be more frequent application. Duration of treatment depends on the effectiveness and tolerability of therapy and is 2-4 weeks.

In the absence of clinical improvement is necessary to clarify the diagnosis.

Side effect

Local reactions: local application of GCS may experience burning, irritation, dryness, folliculitis, hypertrichosis, aknepodobnye eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. With prolonged use, as well as the use of occlusive dressings - maceration of the skin, secondary infection, skin atrophy, sudamen, purpura.

Systemic reactions: when applied to large body surface, mostly in children, may experience systemic side effects of GCS (hyperglycemia, Glycosuria, reversible inhibition of adrenocortical function, the manifestations of Cushing's syndrome) and gentamicin (nephrotoxic and ototoxic effects).

Contraindications
lupus;
cutaneous manifestations of syphilis;
chickenpox;
herpes simplex;
cutaneous vaccination reaction;
open wounds;
Lactation (breastfeeding);
Children under 1 year;
Hypersensitivity to the drug's components.

Pregnancy and lactation

Safety of local application of GCS in pregnancy has not been established. Therefore, prescription drugs in this group during pregnancy is possible only if the potential benefits exceed the risks. If necessary, use Akriderma Ghent during pregnancy should not use the drug in high doses or for a long time.

Unknown is allocated whether betamethasone local application Akriderma Ghent, so if you need to use during lactation should resolve the issue of termination of breastfeeding.

Cautions

If signs of hypersensitivity or skin irritation associated with the use of the drug, discontinue treatment and to pick up the patient adequate therapy.

In long-term treatment with the drug application to the vast surface of the skin using occlusive dressings, as well as children can be systemic absorption of GCS.

On the skin of the face more often than on other surfaces of the body, after long-term treatment of GCS for topical use may appear atrophic changes. The course of treatment in this case should not exceed 5 days. Akriderm Ghent is not intended for use in ophthalmology. Avoid getting product in eyes. With prolonged use its abolition should be gradual.

Use in Pediatrics

Children from 1 year drug appoint only strict indications and under medical supervision, because possible development of systemic side effects associated with betamethasone.

In applying the drug over a large surface and / or the occlusion of viscous may suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of Cushing's can see the decline of excretion of growth hormone, increased intracranial pressure.

Overdose

Acute overdose is unlikely, however, excessive or prolonged use of the drug possible chronic overdose, accompanied by signs of Cushing's: hyperglycemia, Glycosuria, reversible inhibition of adrenocortical function, manifestations of Cushing's syndrome.

Treatment: show the appropriate symptomatic treatment. In the case of chronic toxic effects is recommended phasing out the drug.

Drug Interactions

Drug interactions Akriderm Ghent with other drugs have been discovered.

Terms and Conditions of storage

The drug should be stored out of reach of small children at a temperature of 15 ° to 25 ° C. Shelf life - 2 years.