Diprosalyk - instructions for use, doses, side effects, contraindications

Active substanceBetamethasone + Salicylic acidBetamethasone + Salicylic acid

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Dosage form: & nbspointment for external use

Composition:

1 g of ointment contains:

active ingredients: betamethasone dipropionate 0.64 mg (equivalent to 0.5 mg betamethasone), salicylic acid 30.0 mg;

Excipients: paraffin liquid 100.0 mg, petrolatum 869.36 mg.

Description:

Homogeneous ointment, of a soft consistency, almost white in color, free of visible particles.

Pharmacotherapeutic group:glucocorticosteroid for topical use + keratolytic agent

ATX: & nbsp

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

Pharmacodynamics:

Combined drug based on two active ingredients - betamethasone dipropionate and salicylic acid.

Betamethasone dipropionate - synthetic fluorinated glucocorticosteroid (GCS) - has anti-inflammatory, antipruritic and vasoconstrictive effects.

With topical application salicylic acid has keratolytic, as well as bacteriostatic and some fungicidal action.

Indications:

Reduction of inflammatory manifestations of dry and hyperkeratogenic dermatoses sensitive to SCS therapy, including psoriasis, chronic atopic dermatitis, neurodermatitis (chronic simple lichen), flat lichen, eczema (including coin-like eczema, eczema of the hands, eczematous dermatitis), dyshidrosis, seborrheic dermatitis of the scalp, ichthyosis and other ichthyosis-like conditions.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- children under 2 years;

- pregnancy (long-term treatment in large doses);

- lactation period;

- rosacea;

- perioral dermatitis;

- bacterial, viral or fungal skin infection (pyoderma, syphilis, skin tuberculosis, Herpes simplex, chickenpox, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis);

- trophic ulcers on the background of chronic venous insufficiency;

- skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma);

- postvaccinal skin reactions.

Carefully:

- Children under 12 years;

- liver failure;

- long-term treatment, use on large areas of the skin, the use of occlusive dressings.

Pregnancy and lactation:

Due to the fact that the safety of the use of local GCS in pregnant women is not established, the purpose of this class of drugs during pregnancy is justified only if the potential benefit to the mother exceeds the potential risk to the fetus.

Preparations of this class should not be used during pregnancy in large doses or for a long time.

Since it has not been determined to date whether the level of systemic absorption of local GCS is sufficient for the appearance of their detectable concentrations in the mother's milk, it should stop either breastfeeding or the use of the drug, given how much it is needed for the mother.

Dosing and Administration:

Outwardly.

Apply a thin layer 2 times a day - in the morning and at night, completely covering the affected areas of the skin. In some patients, the supporting effect can be achieved by less frequent applica- tions.

Children aged 2 to 12 years - Apply a thin layer on a small area of the skin 1 or 2 times a day for no more than 1 week.

Side effects:

Adverse events that occurred with the use of local SCS included burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis, purpura, telangiectasia, local hirsutism, dermatitis.

The following phenomena often occurred with the application of occlusive dressings: skin maceration, secondary infection, skin atrophy, striae and sweating.

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

Overdose:

Symptoms. Long-term use of local GCS in large doses can cause oppression of the pituitary-adrenal system, leading to secondary adrenal insufficiency and hypercorticoid phenomena, including Cushing's syndrome. Long-term use in large doses of drugs containing salicylic acid, can lead to poisoning with salicylic acid.

Treatment. The corresponding symptomatic treatment was shown. Acute symptoms of hypercorticoidism are usually reversible. If necessary - correction of electrolyte imbalance.In the case of chronic toxicity, the gradual elimination of GCS is recommended. In overdose of salicylates, treatment is also symptomatic. It is necessary to take measures for the early removal of salicylates from the body, for example, ingestion of sodium bicarbonate (for urine alkalinization) and forcing diuresis.

Interaction:

No interaction of the drug Diprosalik® ointment with other drugs has been recorded.

Special instructions:

If the preparation has developed irritation or hypersensitivity, treatment should be discontinued.

In case of infection, appropriate therapy should be prescribed.

With topical application of GCS, especially in children, there may be side effects that are characteristic of systemic SCS, including oppression of the hypothalamic-pituitary-adrenal system.

Systemic absorption of GCS and salicylic acid in their local application will be higher with the use of occlusive dressings, as well as if extensive body surfaces are treated.

With prolonged treatment with the drug, it is recommended to cancel it gradually.

The drug is not intended for use in ophthalmology.Avoid contact with eyes and mucous membranes.

Pediatric Use

Use in children under the age of 12 is possible only under medical supervision. Children more than adults are at risk of oppression of the function of the hypothalamic-pituitary-adrenal system when using local GCS because of the greater ratio of the surface area of the body to its mass and, consequently, increased absorption of the drug.

There were reports of a decrease in the function of the hypothalamic-pituitary-adrenal system, Cushing's syndrome, growth retardation, insufficient weight gain and increased intracranial pressure in children receiving SCS for topical use. The oppression of the hypothalamic-pituitary-adrenal system in children is determined by the low level of cortisol in the plasma and the lack of response to stimulation of adrenocorticotropic hormone. Increase in intracranial pressure is manifested by protrusion of the fontanel, headaches, bilateral edema of the optic disc.

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

There was no any effect of Diprosalik® on the ability to drive vehicles and work with mechanisms.

Form release / dosage:

Ointment for external use, 0.05% + 3%.

Packaging:

For 30 g in aluminum tubes treated with epoxy varnish and closed with a membrane and a screwed polyethylene cap with a perforator to open the membrane.

One tube with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011343 / 02

Date of registration:11.08.2008

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp20.11.2015

Illustrated instructions

Instructions

Diprosalic® (Diprosalic®)