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

Excipients: citric acid monohydrate 0.5 mg, propylene glycol 100.0 mg, cetostearyl alcohol (cetyl alcohol 60%, stearic alcohol 40%) 10.0 mg, lanolin alcohol 10.0 mg, glycerol monostearate 30.0 mg, paraffin liquid - 116.0 mg, Vaseline - up to 1 g.

Description:

White or almost white, translucent ointment.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:

Mometasone is a synthetic glucocorticosteroid (GCS). Has anti-inflammatory, antipruritic and antiexudative action. SCS induces the release of proteins that inhibit phospholipase A₂ and known collectively as 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 mometasone is low. 8 hours after application on intact skin (without occlusive dressing), about 0.4% dose. With inflammation and damage to the skin, absorption increases.

Indications:

Inflammation and itching of the skin with dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis), in which therapy is shown.

Contraindications:

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

Pink acne, perioral dermatitis.

Bacterial, viral (Herpes simplex, chickenpox, Herpes zoster) or fungal infection of the skin.

Tuberculosis, syphilis.

Post-vaccination reactions.

Pregnancy (treatment of extensive skin areas, long-term treatment).

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

Children under 2 years.

Carefully:

Applying to the face skin and intertriginoznuyu surface of the skin, the use of occlusive dressings, as well as the treatment of large areas of the skin and / or long-term treatment (especially in children).

Pregnancy and lactation:

The safety of mometasone 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.

Adults:

Apply a small amount of ointment to the affected area of the skin 1 time per day. Ointment should not be used when applying hermetic bandages. Continuous drug treatment should not last more than 2 weeks. Do not use ointment on the face skin for more than 5 days.

Children:

Do not use in children younger than 2 years.

In children older than 2 years, the drug can be used only in case of emergency on a small area of the skin, once a day, a maximum of 5 days. In children, the drug should be used with great care and should not be applied to the skin of the face.

Side effects:

Local reactions: burning, itching, paresthesia, folliculitis, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, attachment of secondary infection, striae, sweating.

The probability of occurrence of the listed undesirable phenomena increases at application of occlusive dressings.

System Action: when external forms of SCS are used for a long time and / or for the treatment of large areas of the skin (the total area of application is larger than the palm of the patient) or with the use of occlusive dressings, especially in children and adolescents, side effects typical for SCS of systemic action may occur, 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 cancellation).

Interaction:

There is no data on the interaction with other medicinal substances in the external application of GCS.

However, varicella vaccination and other immunizations should not be given to patients using this medication, especially with prolonged use on a large surface of the skin, since there is a risk of a lack of development of a normal immune response in the form of the appearance of appropriate antibodies.

The drug can enhance the action of immunosuppressive drugs and weaken the action of immunostimulating drugs.

Special instructions:

If there is no effect within 2 weeks of therapy, the diagnosis should be clarified.

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, it is necessary to monitor the function of the hypothalamic-pituitary-adrenal system.

Avoid contact with the eyes.

Propylene glycol, 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.

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. The use of the drug in children for more than 3 weeks has not been studied.

Children should receive a minimum dose of the drug sufficient to achieve the effect.

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

Data on the adverse effects of the drug on the ability to control vehicles and mechanisms are not available.

Form release / dosage:Ointment for external use, 0.1%.

Packaging:

For 15 g of the drug in aluminum tubes with a varnished inner surface, sealed with a plastic cap.

The tube is placed in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001376

Date of registration:20.12.2011 / 10.02.2014

Expiration Date:20.12.2016

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

PHARMACEUTICAL WORKS JELFA, S.A. Poland

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp13.06.2018

Illustrated instructions

Instructions

Momederm® (Momederm®)