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

Hexylene glycol 120.0 mg, hydrogenated phosphatidalcholine (hydrogenated soy lecithin) 15.0 mg, starch aluminum octenyl succinate 100.0 mg, titanium dioxide 10.0 mg, white beeswax 50.0 mg, petroleum jelly 674, 0 mg, phosphoric acid - q.s. (until pH is established), purified water - 30.0 mg.

Description:

A homogeneous white or almost white cream with a soft consistency, 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 to arachidonic acid.

Pharmacokinetics:Absorption of the drug Elokom® cream is negligible.8 hours after application to the intact skin (without occlusive dressing), approximately 0.4% of the steroid is found in the systemic circulation.

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. SCS penetrates the placental barrier. Long-term treatment and use of large doses duringpregnancy in connection with the threat of adverse effects on the development of the fetus.

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 Elokom® cream 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:

Undesirable reactions indicating body system and frequency very often (≥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 determined based on available data)

Infections and invasions

Rarely

Folliculitis, secondary infection

From the skin and subcutaneous tissue

Rarely

Skin irritation, dry skin, burning sensation, itching, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, striae, sweating, papules, pustules

From the nervous system

Frequency not set

Paresthesia

When applying external forms of GCS for long time and / or when applied to large areas of the skin, or using occlusive dressings, especially j/ children and adolescents may experience side effects that are characteristic of SCS of 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 Elokom® cream with other drugs has been reported.

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 contact with Elocom® cream in the eyes.

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 rednessskin 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:

The effects of the Elocom® cream drug on the ability to drive a car or moving machinery have not been noted.

Form release / dosage:

Cream 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. 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:

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

Terms of leave from pharmacies:On prescription

Registration number:П N013256 / 02

Date of registration:18.01.2008 / 02.09.2013

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®)