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: propyl parahydroxybenzoate (Nipasol) 0.05 g Liquid paraffin (vaseline oil) 5 g, 1 g of isopropyl palmitate, petrolatum to 100 g

Description:Translucent ointment 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).

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:

Adults

Ointment 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. On areas of skin with thicker epidermis and in places from which the drug is easily eliminated (palms and feet), ointment should be applied more often. The duration of treatment depends on the effectiveness and tolerability of therapy and is, as a rule, no more than 2-4 weeks.

Children

Children are allowed to prescribe the drug from two years only on strict indications and under the supervision of a doctor.

In connection with the fact that in children the area of the skin with respect to the body weight is greater, and the epidermis is not sufficiently developed,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.

Side effects:

Very rarely, when applying ointment Akriderm® Gent says: burning sensation, erythema, exudation, pigmentation disorders and itch.

Adverse reactions that occur when applying local GCS: (Particularly when using occlusive dressings): burning sensation, itching, dryness, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, sudamen.

Extremely rare (in cases of significant systemic absorption gentamicin) there is a risk of damage of the auditory nerve and the vestibular apparatus, accompanied by tinnitus and impaired hearing.

Such side effects develop when patients simultaneously take ototoxic or nephrotoxic drugs and if the kidney function is impaired.

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

In children, oppression of the pituitary-hypothalamic-adrenal system, Cushing syndrome, growth retardation, lag in weight gain, increased intracranial pressure (betamethasone).

Overdose:

Symptoms: with prolonged use of local SCS in high doses, it is possible to suppress adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, 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:

Acryderm® GENTA Ointment is not recommended for use on the face and scalp.

It is not recommended to use ointment under occlusive dressings, except when necessary.

Do not allow Acrydrom® GENTA to fall into the eyes and periorbital area.

Acryderm® GENTA ointment for external use should not be used to treat varicose trophic ulcers of the lower leg and open wounds.

With the long-term use of the Acriderm® GENTA ointment on large skin surfaces with compromised integrity, there is the potential for absorption of gentamicin and, consequently, the development of symptoms of ototoxicity.

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.

In cases of fungal superinfection, an additional use of an antifungal drug is necessary.

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

Data on the adverse effects of the drug on the ability to control vehicles and mechanisms are not available.

Form release / dosage:

Ointment for external use, 0.05% + 0.1%.

Packaging:

For 15 and 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:LSR-006433/08

Date of registration:11.08.2008 / 12.08.2016

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)