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

Composition:100 g of cream contains:
active substance: mometasone furoate - 0.1 g;
Excipients: propylene glycol 12.0 g; propylene glycol monostearate (propylene glycol monopalmitostearate) 8.0 g; purified water - 3.0 g; macrogol cetostearate (Macrogol-20 cetostearyl ether) - 4.0 g; stearyl alcohol - 3.0 g; wax bee white (white wax) - 5.0 g; titanium dioxide - 1.0 g; methyl parahydroxybenzoate (methylparaben) - 0.02 g; propyl parahydroxybenzoate (propylparaben) 0.18 g; talc-10.0 g; phosphoric acid-up to pH 4.0; Vaseline (soft paraffin, petrolatum) - up to 100.0 g.

Description:Homogeneous cream white or almost white.

Pharmacotherapeutic group:Glucocorticosteroid for topical application.

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:Mometasone furoate - 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.After 8 hours after applying to intact skin (without occlusive dressing), about 0.4% mometasone is found in the systemic circulation.

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 SCS;
- rosacea, perioral dermatitis;
- bacterial, viral (herpes virus, varicella) or fungal skin infection;
- tuberculosis, syphilis;
- postvaccinal reactions;
- pregnancy (application to large areas of the skin, prolonged treatment);
- the period of breastfeeding (use in large doses and / or for a long time);
- Children under 2 years of age (due to insufficient data).

Carefully:- application to the face skin and intertriginous skin surface;
- 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 with SCS.

Pregnancy and lactation:Pregnancy
The safety of the use of mometasone furoate during pregnancy and during breastfeeding 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.
Breastfeeding period
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 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:Classification of the incidence of adverse events according to the recommendations of the World Health Organization (WHO):
very often ≥ 1/10;
often from ≥ 1/100 to <1/10;
infrequently from ≥ 1/1000 to <1/100;
rarely from ≥ 1/10000 to <1/1000;
very rarely <1/10000, including individual messages;
the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.
Infectious and parasitic diseases: rarely - folliculitis, a secondary infection.
Disturbances from the skin and subcutaneous tissues:
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. Impaired nervous system: frequency is unknown - paresthesia.
When applying external forms of SCS 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, side effects characteristic of SCS of systemic action, including adrenal insufficiency and Itzenko-Cushing syndrome .

Overdose:Symptoms
Inhibition of the hypothalamic-pituitary-adrenal system, including secondary adrenal insufficiency.
Treatment
Symptomatic, if necessary - correction of water-electrolyte imbalance, drug withdrawal (with prolonged therapy - gradual abolition).

Interaction:Not found.

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.Taking this into account, patients should be observed with respect to signs of suppression of the hypothalamic-pituitary-adrenal system and development of the Itenko-Cushing syndrome.
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 treatment course, the drug should be canceled gradually, for example, by switching to an intermittent treatment regimen before completely stopping treatment.
Any of the side effects described in the systemic application of GCS, including suppression of the adrenal gland function, can also occur with topical 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 the drug on the ability to drive a car or moving mechanisms are not noted.

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

Packaging:For 5 g, 15 g or 30 g in aluminum tubes.
Each tube together with the instruction for use is placed in a pack of cardboard.

Storage conditions:Store at a temperature not exceeding 25 ° C.
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-000073

Date of registration:10.12.2010 / 01.06.2016

Expiration Date:Unlimited

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

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp2016-10-30

Illustrated instructions

Instructions

Silkaren® (Silkaren)