Akriderm Genta ointment, 15 g

Dermatitis (simple and allergic), especially those secondarily infected, eczema (atopic, children's, coin-like), atopic dermatitis (diffuse neurodermatitis), simple chronic lichen (limited neurodermatitis), solar dermatitis, exfoliative dermatitis, radiation dermatitis, diaper rash, psoriasis, pruritus.

Adults
Apply a thin layer of the ointment to the affected area of ??the skin and surrounding tissues 2 times a day (morning and evening), rubbing lightly in a circular motion. On areas of the skin with a thicker epidermis and in places from which the drug is easily removed (palms and feet), the ointment should be applied more often. The duration of treatment depends on the effectiveness and tolerability of therapy and is usually no more than 2-4 weeks.
Children
Children are allowed to prescribe the drug from the age of two only on strict indications and under the supervision of a doctor.
Due to the fact that in children the area of ??the skin in relation to body weight is larger, and the epidermis is also underdeveloped, with external use of the drug, absorption of a proportionally larger amount of active substances is possible and, therefore, there is a greater risk of developing systemic side effects. The drug should be used in children as soon as possible and in compliance with all precautions.

in 100 g of ointment:
active substances: betamethasone dipropionate - 0.064 g, gentamicin sulfate in terms of the active anhydrous substance - 0.1 g and
auxiliary substances: propyl parahydroxybenzoate (nipazole), liquid paraffin (liquid paraffin), isopropyl palmitate, petroleum jelly.

Hypersensitivity to betamethasone, gentamicin or to any of the excipients that make up the drug.
Skin tuberculosis, vaccines, viral skin infections, perioral dermatitis, rosacea.
Skin manifestations of syphilis, skin post-vaccination reactions, childhood (up to 2 years).

Trade name of the drug: AkridermЃ GENTA

International non-proprietary name or grouping name:
Betamethasone + Gentamicin

Dosage form:

topical ointment

Composition:

in 100 g of ointment:
active substances: betamethasone dipropionate - 0.064 g, gentamicin sulfate in terms of the active anhydrous substance - 0.1 g and
auxiliary substances: propyl parahydroxybenzoate (nipazole), liquid paraffin (liquid paraffin), isopropyl palmitate, petroleum jelly.

Description A
translucent white or almost white ointment.

Pharmacotherapeutic group:

Topical glucocorticosteroid + aminoglycoside antibiotic

Pharmacological action
Pharmacodynamics
Anti-inflammatory, anti-allergic, antipruritic, antibacterial agent.
Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) that has anti-inflammatory, anti-allergic, antipruritic and vasoconstrictor effects. When applied topically, it narrows blood 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 hyaluronidase activity 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, which mediate cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to the development of inflammation, allergies and other pathological processes).
Gentamicin is a broad-spectrum antibiotic of the aminoglycoside group. It has a bactericidal effect and provides a 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? - and? -hemolytic streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some strains producing penicillinase).

Pharmacokinetics
When the drug is used externally in therapeutic doses, the transdermal absorption of active substances into the blood is very insignificant. The use of occlusive dressings increases the absorption of betamethasone and gentamicin, which may lead to an increased risk of systemic side effects.

Indications for use
Dermatitis (simple and allergic), especially those secondarily infected, eczema (atopic, children's, coin-like), atopic dermatitis (diffuse neurodermatitis), simple chronic lichen (limited neurodermatitis), solar 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.
Skin tuberculosis, vaccines, viral skin infections, perioral dermatitis, rosacea.
Skin manifestations of syphilis, skin post-vaccination reactions, childhood (up to 2 years).

Application during pregnancy and lactation The
safety of topical administration of glucocorticosteroids in pregnant women has not been established; the prescription of drugs of this group during pregnancy is justified only if the potential benefit to the mother outweighs the possible risk to the fetus. During pregnancy, drugs in this group should not be used in high doses or for a long time.
It has not been established whether the drug passes into breast milk, so breastfeeding should be abandoned.

Method of administration and dosage

Adults
Apply a thin layer of the ointment to the affected area of ??the skin and surrounding tissues 2 times a day (morning and evening), rubbing lightly in a circular motion. On areas of the skin with a thicker epidermis and in places from which the drug is easily removed (palms and feet), the ointment should be applied more often. The duration of treatment depends on the effectiveness and tolerability of therapy and is usually no more than 2-4 weeks.
Children
Children are allowed to prescribe the drug from the age of two only on strict indications and under the supervision of a doctor.
Due to the fact that in children the area of ??the skin in relation to body weight is larger, and the epidermis is also underdeveloped, with external use of the drug, absorption of a proportionally larger amount of active substances is possible and, therefore, there is a greater risk of developing systemic side effects. The drug should be used in children as soon as possible and in compliance with all precautions.

Side effects
Very rarely, when using AkridermЃ GENTA ointment, the following are noted: burning sensation, erythema, exudation, pigmentation disorders and itching.
Adverse reactions that occur when using local GCS: (especially when using occlusive dressings): burning sensation, itching, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, the development of a secondary infection, skin atrophy, striae, prickly heat.
It is extremely rare (in cases of significant systemic absorption of gentamicin) there is a risk of damage to the auditory nerve and vestibular apparatus, accompanied by tinnitus and hearing impairment. Such side effects develop when patients are simultaneously taking ototoxic or nephrotoxic drugs and with impaired renal function.
With prolonged treatment or application to a large surface - the development of systemic side effects of glucocorticosteroids: increased body weight, osteoporosis, increased blood pressure, edema, ulceration of the mucous membrane of the gastrointestinal tract, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, menstrual irregularities.
In children, suppression of the pituitary-hypothalamus-adrenal glands system, Cushing's syndrome, growth retardation, lag in weight gain, increased intracranial pressure (betamethasone).

Overdose
Symptoms: With long-term use of local GCS in high doses, it is possible to suppress the function of the adrenal glands with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's syndrome.
With a single overdose of gentamicin, no symptoms are expected.
Long-term treatment with high doses of gentamicin can lead to the growth of insensitive flora.
Treatment: Symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, the electrolyte balance is corrected.

Interaction with other medicinal products
Interactions of the drug with other medicinal products have not been identified.

Special instructions
Ointment AkridermЃ GENTA is not recommended for use on the skin of the face and scalp.
It is not recommended to use the ointment under occlusive dressings, except when necessary.
Do not allow AkridermЃ GENTA ointment to get into the eyes and on the periorbital area.
AkridermЃ GENTA ointment for external use should not be used for the treatment of varicose ulcers of the leg and open wounds.
With prolonged use of AkridermЃ GENTA ointment on large areas of skin with impaired integrity, there is a potential for gentamicin absorption and, accordingly, the development of ototoxicity symptoms.
Certain areas of the body (groin folds, armpits and perianal region) are more at risk of striae. Therefore, the duration of use of the drug in these areas of the body should be limited.
In cases of fungal superinfection, additional use of an antifungal drug is necessary.

Influence on the ability to drive vehicles and mechanisms There are no
data on the adverse effects of the drug on the ability to drive vehicles and mechanisms.

Release form
Ointment for external use.
15 and 30 g in an aluminum tube. Each tube, together with instructions for use, is placed in a cardboard box.

Storage conditions
At temperatures from 15 to 25 ? C.
Keep out of the reach of children.

Shelf life is
2 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies
Without prescription.