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

Excipients: isopropanol 400.0 mg, propylene glycol 300.0 mg, giprolose - 1.5 mg, sodium dihydrogen phosphate dihydrate - 2.26 mg, phosphoric acid acid 85 % - q.s. until the pH is 3.5-5.5, the water is purified - q.s. up to 1000 mg.

Description:

Colorless or slightly yellowish solution.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:

Mometasone is a glucocorticosteroid for external use. It has anti-inflammatory, antipruritic and vasoconstrictive properties. Generally the mechanism of anti-inflammatory action of glucocorticosteroids (GCS) of topical application is unclear. It is believed that SCS induce, release of proteins inhibiting phospholipase A2 and known under the general name of lipocortins. It is believed that these proteins control the biosynthesis of such potent inflammatory mediators as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by the action of phospholipase A2. In the experiments in vitro it was shown that mometasone is a potent inhibitor of the synthesis of three cytokines involved in the development of the inflammatory process and its maintenance: interleukin-1 (IL-1), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα).

Pharmacokinetics:

In case of inflammation or damage to the skin, absorption of Elocom® Lotion (0.1% solution for external use) is accelerated. 8 hours after application to the intact skin (without occlusive dressing), approximately 0.7% of the applied dose of the drug is found in the systemic circulation.

Indications:

Inflammation and itching in dermatoses that respond to glucocorticosteroid therapy (including psoriasis), with lesions of the hairy areas of the skin.

Contraindications:

- Hypersensitivity to GCS or to any component of the drug.

- Pink acne, perioral dermatitis.

- Bacterial, viral (simple herpes, chicken pox, shingles) or fungal skin infection.

- Tuberculosis, syphilis.

- Post-vaccination reactions.

- Children under 2 years.

- Pregnancy (treatment of extensive skin areas and / or long-term treatment).

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

Carefully:

As for all GCS, Elocom® Lotion should be used with caution when large areas of the body and / or with prolonged use (especially in children). It is not recommended to use in natural skin folds, apply to the skin face, apply occlusive dressings. Long-term therapy of SCS of systemic action.

Pregnancy and lactation:

To prescribe during pregnancy in cases where the alleged, benefit to the mother exceeds the potential risk to the fetus; while using small doses and applying a short time.

SCS is excreted in breast milk, so if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Outwardly.

Apply several drops of Elokom® Lotion to affected areas of the skin once a day. After applying, rub softly massaging movements to full absorption from the skin surface. For the most effective and economical use of the drug, bring the spout of the vial to the affected area of the skin and gently squeeze the vial.The duration of the course of treatment is determined by the doctor on the basis of an assessment of the effectiveness of the drug, as well as the tolerability of the drug by the patient, the presence and severity of side effects.

Side effects:

Irritation and dry skin, burning sensation, itching, folliculitis, furunculosis,hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, sweating.

When external forms of SCS are used for a long time and / or for the treatment of large areas of the skin, or with the use of occlusive dressings, especially in children and adolescents, side effects characteristic of systemic SCS, including suppression of function, hypothalamic-pituitary-adrenal system , Itenko-Cushing syndrome, hyperglycemia and glucosuria.

Overdose:

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

Treatment: symptomatic, if necessary - correction of violations of water-electrolyte metabolism, drug discontinuation (with prolonged therapy - gradual cancellation).

Interaction:No interaction of the drug Elokom® Lotion with other medications has been recorded.

Special instructions:

In the treatment of large areas of the skin for a long time, especially with the use of occlusive dressings, the degree of absorption of GCS in the systemic blood flow and the development of systemic action of GCS increases. 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 Eloc® Lotion in the eyes.

Propylene glycol, which is part of the preparation, can cause irritation at the site of application, and isopropanol - a burning sensation when ingested on inflamed skin. AT In such cases, Elocom® Lotion should be discontinued and appropriate treatment should be prescribed. If a concomitant skin infection develops, the necessary antifungal, antiviral or antibacterial agent should be used. In the absence of a rapid positive response to treatment, it is necessary to cancel the GCS before the infection is eliminated.

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.

With prolonged therapy with SCS, sudden discontinuation of therapy can lead to the development of withdrawal 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

The safety and efficacy of mometasone in topical application in children for more than 6 weeks have not been studied.

Due to the fact that in children the ratio of surface area and body weight is larger than that of adults, children are at greater risk of suppressing the function hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome in the application of any local SCS. Long-term GCS treatment of children 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 the Elocom® drug Lotion on the ability to drive or move vehicles is not noted.

Form release / dosage:

Solution for external use 0,1%.

Packaging:

To 30 ml in a bottle-dropper, made of low-density polyethylene.

The bottle-dropper is closed with a screw-on plastic cap.

1 bottle-dropper along with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N015969 / 01

Date of registration:15.09.2009 / 13.05.2016

Expiration Date:Unlimited

The owner of the registration certificate:MSD FARMASYUTIKALS, LLC MSD FARMASYUTIKALS, LLC Russia

Manufacturer: & nbsp

BAYER Inc. Canada

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp10.08.2016

Illustrated instructions

Instructions

Elokom® Lotion (Elocom® Lotion)