Instruction for use: Akriderm GENTA

Active substance Betamethasone + Gentamycin

ATX code D07CC01 Betamethasone in combination with antibiotics

Pharmacological group

Glucocorticosteroids in combinations

Nosological classification (ICD-10)

L20 Atopic dermatitis

Itchy atopic eczema, Common neurodermatitis, Allergic skin diseases, Allergic skin diseases of non-infectious etiology, Allergic skin diseases of non-microbial etiology, Allergic skin diseases, Allergic skin lesions, Allergic manifestations on the skin, Allergic dermatitis, Allergic diathesis, Allergic itching dermatosis, Allergic Skin Disease, Allergic skin irritation, Dermatitis allergic, Atopic dermatitis, Dermatosis allergic, Diathesis exudative, Skin Allergic Disease, Skin allergic reaction to medicinal and chemical preparations, Skin reaction to medication, Skin and allergic disease, Acute eczema, Chronic atopic dermatitis, Exudative diathesis, Itching allergic dermatosis

L23 Allergic contact dermatitis

Allergic dermatitis, Purulent allergic dermatopathies, Contact allergic reaction, Contact allergic dermatitis, Photoallergic contact dermatitis

L26 Exfoliative dermatitis

Dermatitis exfoliative, Exfoliative dermatitis generalized

L28.0 Simple chronic lichen

Common lichen, Chronic and simple lichen, Chronic lichen

L30.0 Coin-like eczema

Dermatitis coiniform, Ordinary coin-like eczema, Eczema coin-like, Nummular dermatitis

L30.3 Infectious dermatitis

Microbial skin infections, Dermatitis with concomitant bacterial infections, Dermatitis in the presence of a bacterial infection or suspected of it, Infected eczema of external auditory canal, Secondarily infected dermatosis, Erythema migrans, Secondarily infected dermatoses , Dermatitis re-infected, Infectious dermatitis, Dermatitis infected, Dermatoses complicated by a secondary infection, Dermatoses complicated by primary and secondary infection, Dermatoses complicated by primary and / or secondary infection, Infected eczema, Infected dermatitis, Infected dermatosis, Migrating erythema, Microbial eczema, Chronic migratory erythema, Eczema is infected, Erythema Migrating, Bacterial dermatitis, Erythema migratory chronic, Superinfectant dermatitis, Necrolytic Migrating erythema

L30.4 Erythematous intertrigo

Erythema of the buttocks, Dermatitis traumatic, Intertrigo, Interdigital intertrigo

L30.9 Dermatitis, unspecified

Allergic dermatoses complicated by a secondary bacterial infection, Anal eczema, Bacterial maturation, Varicose Eczema, Venous dermatitis, Inflammation of the skin, Inflammation of the skin upon contact with plants, Inflammatory Skin Diseases, Inflammatory skin reactions, Inflammatory processes of the skin, Hypostatic dermatitis, Fungal Eczema, Fungal dermatosis, Dermatitis, Dermatitis is stagnant, Dermatitis and eczema in the anal area, Dermatitis acute contact, Perianal dermatitis, Dermatosis, Dermatosis of the scalp, Dermatosis of psoriasis, Dermatosis with persistent itching, Dermatoses, Dermatoses itchy, Other itching dermatoses, Significant eczematous manifestations, Itching with, dermatoses, Itching eczema, True eczema, Skin reaction to insect bites,Skin itching with dermatosis, Constitutional eczema, Weeping eczema, Drowsing inflammatory skin disease, Dying Infectious-Inflammatory Skin Disease, Non-allergic dermatitis, Nummular eczema, Acute contact eczema, Acute inflammatory skin disease, Acute dermatosis, Acute severe dermatosis, Perianal dermatitis, Superficial dermatosis, Subacute Contact Eczema, Simple dermatitis, Occupational dermatitis, Psychogenic dermatosis, Bubble dermatitis of newborns, Pustular eruptions, Irritation and redness of the skin, Low-flammable eczema, Dry atrophic eczema, Dry eczema, Toxic dermatitis, Ear eczema like dermatitis, Chronic eczema, Chronic dermatosis, Chronic common dermatosis, Scaly papular dermatosis, Eczema, Eczema anal region, Eczema of the hands, Eczema Contact, Eczema lichenized, Eczema Nummular, Eczema acute, Eczema acute contact, Eczema subacute, Eczematous dermatitis, Eczema-like rashes, Ecome exogenous, Endogenous eczema, Gluteal dermatitis, Restricted itchy dermatitis

L40 Psoriasis

Chronic psoriasis with diffuse plaques, Generalized psoriasis, Psoriasis of the scalp, Psoriasis of the scalp, Generalized form of psoriasis, Psoriasis dermatitis, Psoriasis complicated by erythroderma, Invalidative psoriasis, Isolated psoriatic plaque, Exfoliative psoriasis, Psoriatic Erythroderma, Psoriasis with eczematosis, Hyperkeratosis in psoriasis,Inverse psoriasis,Psoriasis eczematous, Dermatosis of psoriasis, Psoriasis of the genitals, Psoriasis with lesions of hairy areas of skin, Erythrodermal psoriasis, Chronic psoriasis of the scalp, Chronic psoriasis, Ordinary psoriasis, Refractory psoriasis, Kebner phenomenon, Scaly lichen

L57.8 Other skin changes caused by chronic exposure to non-ionizing radiation

Photosensitivity

L58 Radiation dermatitis radiation

Radiation injury of the skin, Radiation skin lesions, Radiation damage to the skin and mucous membranes, Skin lesion with radiation therapy, Irritation after exposure to X-rays, Radiation damage to the skin, Radio-epileleitis, Radiation acute syndrome

Composition and form of release

AkridermŽ

Cream 1 g

Betamethasone dipropionate 0.64 mg

Auxiliary substances: nipagin; Paraffin wax; petrolatum; Propylene glycol; Oil vaseline medical; Alcohol cetostearyl emulsifying type A or wax emulsifying type "Lanette SX"; Disodium ethylenediaminetetraacetic acid (Trilon B); Sodium sulfite 7-water; purified water

In tubes of 15 or 30 g; In a pack of cardboard 1 tuba.

AkridermŽ GENTA

Cream for external use 1 g

Betamethasone dipropionate 0.64 mg

Gentamycin sulfate 1 mg

Auxiliary substances: nipagin; Propylene glycol; Oil vaseline; Macrogol ether 20 cetostearyl; Cetostearyl alcohol; Disodium ethylenediaminetetraacetate; Sodium phosphate disubstituted; Potassium phosphate monosubstituted; purified water

In tubes of 15 or 30 g; In a pack of cardboard 1 tuba.

AkridermŽ GK

Cream for external use 1 g

Betamethasone dipropionate 0.64 mg

Clotrimazole 10 mg

Gentamycin sulfate 1 mg

Auxiliary substances: petrolatum; Propylene glycol; Oil vaseline medical; Cetostearyl alcohol; Macrogol ester of cetostearyl; Trilon B; Sodium dihydrogen phosphate dihydrate (sodium phosphate-acid monosubstituted 2-water); purified water

In tubes of 15 or 30 g; In a pack of cardboard 1 tuba.

AkridermŽ SC

Ointment for external use 1 g

Betamethasone dipropionate 0.64 mg

(Equivalent to 0.5 mg betamethasone)

Salicylic acid 30 mg

Auxiliary substances: petrolatum; Vaseline oil

In tubes of 15 g or 30 g; In a pack of cardboard 1 tuba.

Description of dosage form

The cream is white or almost white in color.

Ointment - from white to white with a yellowish or kremovatym shade of color. A weak specific odor is allowed.

Characteristic

AkridermŽ

Glucocorticosteroid for topical application.

AkridermŽ GENTA

Combination drug for external use (glucocorticosteroid + antibiotic-aminoglycoside).

AkridermŽ GK

Combination drug for external use (glucocorticosteroid + antibiotic-aminoglycoside + antifungal agent).

AkridermŽ SC

Combination drug for external use (glucocorticosteroid + keratolytic agent).

pharmachologic effect

AkridermŽ

Anti-inflammatory, anti-allergic, antiexudative, decongestant, antipruritic

AkridermŽ GENTA

Anti-inflammatory, anti-allergic, antibacterial

AkridermŽ GK

Anti-inflammatory, anti-allergic, antibacterial, antifungal

AkridermŽ SC

Anti-inflammatory, antiallergic, antiseptic, keratolytic

Pharmacodynamics

The corticosteroid betamethasone dipropionate inhibits the accumulation of leukocytes, the release of lysosomal enzymes and proinflammatory mediators in the inflammatory focus, 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), Staphytococcus spp. (Coagulase-positive, coagulase-negative and some strains producing penicillinase). Inactive against anaerobes, fungi and viruses.

Clotrimazole has an antifungal effect due to a disruption in the synthesis of ergosterol, which is an integral part of the cell membrane of fungi. It is active against: Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furtur (Pityrosporum orbiculare).

Salicylic acid provides keratolytic, antimicrobial action, eliminates horny layers and promotes deeper penetration of GCS.

Indications

AkridermŽ

Allergic skin diseases (including acute, subacute and chronic contact dermatitis, occupational dermatitis, seborrheic dermatitis, atopic dermatitis, sun dermatitis, neurodermatitis, pruritus, dyshidrotic dermatitis, eczema); Acute and chronic forms of non-allergic dermatitis; psoriasis.

AkridermŽ GENTA

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.

AkridermŽ GK

Treatment of dermatoses complicated by primary and / or secondary infection, pityriasis, limited and diffuse neurodermatitis, dermatomycosis (including inguinal, stop) caused by drug-susceptible pathogens.

AkridermŽ SC

Local treatment of dermatoses accompanied by hyperkeratosis: psoriasis, limited and diffuse neurodermatitis, lichen planus, eczema, dyshidrotic dermatitis, ichthyosis and ichthyosiform changes.

Contraindications

Hypersensitivity to any of the components of the drug, skin tuberculosis, cutaneous manifestations of syphilis, chickenpox, herpes simplex, skin post-vaccination reactions, open wounds, lactation and children under 1 year; In addition to AkridermŽ: trophic ulcers of the lower leg, rosacea, acne vulgaris; In addition to AkridermŽ GK: in the treatment of external otitis - perforation of the tympanic membrane; Additionally for AkridermŽ SK: perioral dermatitis.

pregnancy and lactation

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

It is not established whether local application of GCS can cause them to appear in the mother's milk, therefore, the question of stopping breastfeeding should be addressed.

Side effects

When topical application of GCS can occur: burning, irritation, dry skin, folliculitis, hypertrichosis, acne-like eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. With prolonged use, as well as the use of occlusive dressings - skin maceration, secondary infection, skin atrophy, sweating, purpura.

AkridermŽ

When applied to extensive body surfaces, mainly in children, systemic side effects of GCS may occur (hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing's syndrome).

AkridermŽ GENTA

AkridermŽ GK

When applied to extensive body surfaces, mainly in children, the occurrence of systemic side effects of GCS (hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing's syndrome) and gentamicin (nephrotoxic and ototoxic effect) may occur.

AkridermŽ SC

When applied to extensive body surfaces, mainly in children, systemic side effects of GCS and salicylates may occur.

If there are any side effects not described in the instructions, you should consult your doctor.

Interaction

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

Dosing and Administration

AkridermŽ

AkridermŽ GENTA

AkridermŽ GK

Outwardly. Apply a thin layer on the affected area of the skin 2 times a day - in the morning and in the evening. Another frequency of use can be determined by the doctor, based on the severity of the disease. In light cases, the cream is sufficient to apply, as a rule, 1 time per day; With more severe lesions may need more frequent use.

The duration of treatment depends on the effectiveness and tolerability of therapy and is 2-4 weeks.

If clinical improvement does not occur, it is necessary to clarify the diagnosis.

AkridermŽ SC

Outwardly. Apply a thin layer on the affected area of the skin 2 times a day - in the morning and in the evening. Another frequency of use can be determined by the doctor, based on the severity of the disease. In light cases, the ointment is sufficient to apply, as a rule, 1 time per day; With more severe lesions may need more frequent use.

Overdose

Acute overdose is unlikely, but with excessive or prolonged use of drugs, a chronic overdose is possible, accompanied by signs of hypercorticism: hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing's syndrome.

Treatment: symptomatic therapy. In the case of chronic toxic effects, a gradual withdrawal of the drug is recommended.

special instructions

If there are signs of increased sensitivity or skin irritation associated with the use of drugs, you should stop treatment and choose the patient adequate therapy.

With prolonged treatment, when applying the drugs on the vast surface of the skin, with the use of occlusive dressings, as well as in children, systemic absorption of GCS is possible.

For children from 1 year, drugs are prescribed only according to strict indications and under medical supervision, t. It is possible to develop systemic side effects associated with betamethasone. When applying the drug on extensive surfaces and / or under occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, a decrease in the excretion of growth hormone, an increase in intracranial pressure can be observed.

On the skin of the face more often than on other surfaces of the body, after prolonged treatment of the local SCS, atrophic changes may appear; The course of treatment in this case should not exceed 5 days.

Cream and ointment are not intended for use in ophthalmology. Avoid contact with eyes.

With prolonged use of the drug, it should be canceled gradually.

storage Conditions

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

Cream for external use 0.064% - 4 years.

Cream for external use - 2 years.

Cream for external use 0.05% - 4 years.

Ointment for external use - 3 years.

Do not use after the expiry date printed on the package.