Acryderm GENTA - instructions for use, doses, side effects, contraindications

active substances: betamethasone dipropionate in terms of 100% substance 0.064 g, equivalent to 0.05 g of betamethasone, gentamicin sulfate equivalent to 0.1 g of gentamycin;

Excipients: methyl parahydroxybenzoate 0.2 g, 21.7 g of propylene glycol, 20 g of liquid paraffin, macrogol tsetostearat 1.3g, cetostearyl alcohol [60% cetyl alcohol, stearyl alcohol 40%] 5.7 g Disodium edetate 0.5 g Sodium hydrophosphate dodecahydrate 0.1 g, potassium dihydrogen phosphate 0.9 g, water purified to 100 g.

Description:

The cream is white or almost white.

Pharmacotherapeutic group:Glucocorticosteroid for topical use + antibiotic aminoglycoside

ATX: & nbsp

D.07.X.C.01 Betamethasone in combination with other drugs

Pharmacodynamics:

Anti-inflammatory, anti-allergic, antipruritic, antibacterial.

Betamethasone dipropionate - synthetic glucocorticosteroid (GCS), anti-inflammatory, antiallergic, antipruritic and vasoconstrictive action. With topical application it narrows the vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, interferon gamma (from lymphocytes and macrophages), inhibits the activity of hyaluronidase and reduces the permeability of the vascular wall. Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of mRNA, inducing the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin depresses phospholipase A₂, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to the development of inflammation, allergy and other pathological processes).

Gentamicin is a broad-spectrum antibiotic of the aminoglycoside group. It has bactericidal action and provides highly effective local treatment of primary and secondary bacterial skin infections. Active against gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; and Gram-positive bacteria: Streptococcus spp. (sensitive strains of β- and α-hemolytic streptococcus groups A), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some strains producing penicillinase).

Pharmacokinetics:

With external use of the drug in therapeutic doses, transdermal absorption of active substances into the blood is very small. The use of occlusive dressings increases the absorption of betamethasone and gentamicin, which can lead to an increased risk of systemic side effects.

Indications:

Dermatitis (simple and allergic), especially secondarily infected, eczema (atopic, childish, coin-like), atopic dermatitis (diffuse neurodermatitis), simple chronic lichen (limited neurodermatitis), sun dermatitis, exfoliative dermatitis, radiation dermatitis, diaper rash, psoriasis, itching.

Contraindications:

Hypersensitivity to betamethasone, gentamicin, or to any of the excipients that make up the drug.

Tuberculosis of the skin, vaccination, viral skin infections, perioral dermatitis, rosacea.

Skin manifestations of syphilis, skin postvaccinal reactions, children's age (up to 2 years).

Carefully:

Pregnancy (especially I trimester). Children age from 2 to 18 years.

Pregnancy and lactation:

The safety of topical application of glucocorticosteroids in pregnant women is not established; The prescription of drugs of this group during pregnancy is justified only if the potential benefit to the mother exceeds the possible risk to the fetus. During pregnancy, drugs of this group should not be used in high doses or for a long time.

It is not established whether the drug penetrates into breast milk, so it is necessary to refuse breastfeeding.

Dosing and Administration:

Outwardly. The cream is applied a thin layer on the affected area of the skin and surrounding tissue 2 times a day (morning and evening), lightly rubbing in circular motions, in mild cases, a single application is possible.

The duration of treatment depends on the effectiveness and tolerability of therapy and is, as a rule, no more than 2-4 weeks.

If clinical improvement does not occur in the near future, it is necessary to clarify the diagnosis or change the treatment regimen.

Side effects:

Itching, burning, irritation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation.

When applying occlusive dressings - maceration, infection, skin atrophy, striae, sweating.

With prolonged treatment or application on a large surface - the development of systemic side effects: weight gain, osteoporosis, increased blood pressure, swelling, ulceration of the gastrointestinal mucosa, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, dysmenorrhea.

The children - the oppression of the hypothalamus-pituitary-adrenal system, Cushing's syndrome, growth retardation, retarded weight gain, increased intracranial pressure (betamethasone).

Perhaps a transient skin irritation: itching, erythematous rashes (gentamicin).

Overdose:

Symptoms: Long-term use of local corticosteroids in high doses may suppress adrenal function with the development of secondary adrenal insufficiency and Cushing's symptoms, including Cushing's syndrome.

With a single overdose of gentamicin, no symptoms are expected.

Long-term treatment with gentamicin in elevated doses can lead to an increase in insensitive flora.

Treatment: symptomatic. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correct the electrolyte balance.

Interaction:

Interactions of the drug with other drugs have not been identified.

Special instructions:

It is not recommended to apply on the face and scalp.

Do not allow the cream to enter the eyes and periorbital area.

When there is a stable bacterial microflora, it is necessary to cancel the drug, to prescribe the appropriate therapy.

With prolonged use of the drug on large surfaces of the skin with compromised integrity, there is a potential for absorption of gentamicin and, accordingly, development of ototoxicity symptoms.

Some areas of the body (inguinal folds, axillary cavities and perianal region) are more susceptible to the risk of striae. Therefore, the duration of application of the drug in these areas of the body should be limited.

Due to the fact that in children the area of the skin with respect to body weight is greater than in adults, and the epidermis is also not developed enough,with external application of the drug, absorption is possible proportionally more active substances and, consequently, there is a greater risk of development of systemic side effects. Use the drug in children should be as short as possible and with all precautions.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of the drug on the ability to manage transport means and mechanisms are absent.

Form release / dosage:

Cream for external use, 0.05% + 0.1%.

Packaging:

For 15 or 30 g in an aluminum tube.

Each tube together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000523

Date of registration:23.06.2010 / 15.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp03.07.2017

Illustrated instructions

Instructions

Acriderm® GENTA (Akriderm® GENTA)