Elokom - instructions for use, dose, side effects, contraindications

Hexylene glycol 120 mg, purified water 30.0 mg, phosphoric acid - q.s. until the pH is established, propylene glycol stearate - 20.0 mg, beeswax white - 50.0 mg, petroleum jelly - 779.0 mg.

Description:

Homogeneous ointment is white or almost white, free of visible particles.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:

Mometasone furoate is a synthetic glucocorticosteroid (GCS), which possesses an anti-inflammatory, antipruritic and antiexudative action. SCS induces the release of proteins that inhibit phospholipase A2 and are known collectively lipocortins that control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid.

Pharmacokinetics:

Absorption of the drug Elokom® ointment for external use is negligible. 8 hours after application to the intact skin (without occlusive dressing), about 0.7% of the steroid is found in the systemic blood stream.

Indications:Inflammation and itching in dermatoses that respond to glucocorticosteroid therapy.

Contraindications:

- Hypersensitivity to any component of the drug or SCS;

- Pink acne, perioral dermatitis;

- Bacterial, viral (herpes virus, chickenpox) or fungal skin infection;

- Tuberculosis, syphilis;

- Post-vaccination reactions;

- Pregnancy (application to large areas of the skin, prolonged treatment);

- Lactation period (use in large doses and / and for a long time);

- Children up to 2 years of age (due to insufficient data).

Carefully:

- Application to the skin and intertriginoznuyu skin, the use of occlusive dressings, as well as applying to large areas of the skin and / or long-term treatment (especially in children);

- Long-term therapy GCS.

Pregnancy and lactation:

The safety of the use of mometasone furoate during pregnancy and lactation has not been studied. GCS penetrate the placental barrier. Long-term treatment and use of large doses during pregnancy should be avoided due to the threat of adverse effects on fetal development.

GCS is excreted in breast milk. In the event that the use of GCS is expected in large doses and / or for a long time, breastfeeding should be discontinued.

Dosing and Administration:

Outwardly.

A thin layer of the drug Elokom® ointment for external application is applied to the affected areas of the skin once a day. The duration of the course of treatment is determined by its effectiveness, as well as the patient's tolerance, the presence and severity of side effects.

Side effects:

Unwanted reactions indicating body system and frequency are very frequent (≥1 / 10), often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000); frequency is not set (can not be is based on available data)
Infections and invasions Rarely	Folliculitis, secondary infection
From the skin and subcutaneous tissue Rarely	Skin irritation, dry skin, burning sensation of the skin, itching, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, striae, sweat, papules, pustules.
From the nervous system Frequency not set	Paresthesia

When using external forms of GCS for a long time and / or when applied to large areas of the skin, or with the use of occlusive dressings, especially in children and adolescents may experience side effects that are characteristic of SCS systemic action, including adrenal insufficiency and Isenko-Cushing syndrome.

Overdose:

Symptoms: oppression of the hypothalamic-pituitary-adrenal system, including secondary adrenal insufficiency.

Treatment: symptomatic, if necessary - correction of electrolyte imbalance, drug withdrawal (with prolonged therapy - gradual abolition).

Interaction:

No interaction of the drug Elokom® ointment for external use with other drugs has been recorded.

Special instructions:

When applied to large areas of the skin for a long time, especially with the application of occlusive dressings, it is possible to develop a systemic action of GCS. Given this, patients should be observed in terms of signs of suppression of the hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome.

Avoid ingestion of Elocom® ointment for external use in the eyes.

Propylene glycol stearate, which is part of the preparation, may cause irritation at the site of application.In such cases, discontinue use of the drug and prescribe appropriate treatment.

It should be borne in mind that the GCS is able to change the manifestations of certain skin diseases, which can make it difficult to diagnose. In addition, the use of GCS may be the cause of delayed wound healing.

With prolonged therapy with SCS, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of dermatitis with intense reddening of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be canceled gradually, for example, by switching to an intermittent treatment regimen before it is completely discontinued.

Any of the side effects described in the systemic use of glucocorticosteroids, including suppression of the adrenal glands, may occur with local application, especially in children.

Pediatric Use

Due to the fact that the ratio of surface area and body weight is greater in children than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome with any local GCS.Long-term treatment of children with SCS can lead to disruption of their growth and development. Children should receive a minimum dose of the drug sufficient to achieve the effect.

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

Effects of Elocom® ointment for external use on the ability to drive a car or moving machinery is not noted.

Form release / dosage:Ointment for external use 0,1%.

Packaging:

For 15 g or 30 g in aluminum tubes, closed with a membrane and a screw-on plastic cap. 1 tuba together with instructions for use in a cardboard bundle.

Storage conditions:

In a place inaccessible to children, at a temperature of no higher than 25 ° C.

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013256 / 01

Date of registration:18.01.2008 / 04.10.2013

Expiration Date:Unlimited

The owner of the registration certificate:Schering-Plau N. Labo.Schering-Plau N. Labo. Belgium

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp10.08.2016

Illustrated instructions

Instructions

Elokom® (Elocom®)