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

Excipients: water 33.360 g, paraffin soft white 26,500 g, paraffin liquid 17,500 g, hexylene glycol 10,000 g, cetostearyl alcohol [cetyl alcohol 60%, stearic alcohol 40%] 7,200 g, macrogol cetostearate 2,800 g, cetyl alcohol 1,000 g, glycerol 1,000 g, citric acid 0.250 g, sodium citrate 0.190 g, xanthan gum 0.100 g

Description:Homogeneous white cream of soft consistency, free of visible particles.

Pharmacotherapeutic group:Glucocorticosteroid for topical application.

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:Mometasone - synthetic glucocorticosteroid (GCS), which 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 insignificant. After 8 hours after a single application on intact skin (without occlusive dressing), approximately 0.4% of mometasone dose is found in the systemic circulation.Inflammatory and / or other skin conditions may increase the absorption of the cream.

Mometasone is extensively metabolized in the liver, excreted mainly by the kidneys and in an insignificant quantity with bile.

Indications:

Inflammation and itching in dermatoses (psoriasis, atopic dermatitis, simple chronic lichen (limited neurodermatitis), eczema, insect bites, 1st degree burns, sunburn, red flat lichen, discoid lupus erythematosus), amenable to glucocorticosteroid therapy, in adults and children over 2 years.

The drug in the form of cream is recommended for the treatment of acute inflammatory skin diseases, including those accompanied by the development of wetness, as well as for the treatment of skin inflammation of the scalp.

Contraindications:

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

- Pink acne, perioral dermatitis.

- Bacterial, viral (Herpes simplex, Herpes zoster) or fungal skin infection.

- Tuberculosis, syphilis.

Post vaccination reactions.

- Children under 2 years old.

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

- Lactation period (application to the area of mammary glands, use in large doses and / or for a long time).

Do not apply the drug on the skin of the eyelids!

Carefully:Long-term therapy of SCS of systemic action.

Pregnancy and lactation:

The safety of mometasone during pregnancy and lactation has not been studied.

GCS penetrate the placental barrier.

Apply when pregnant if the intended benefit to the mother exceeds the potential risk to the fetus; while using small doses and applying a short time.

GCS is excreted in breast milk. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Outwardly.

For adults and children over 2 years, a thin layer of Monovo 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.

If there is no clinical effect within 2 weeks of treatment, it is recommended to revise the diagnosis.

Use in children

The safety and efficacy of mometasone in topical application in children older than 2 years for a period exceeding 3 weeks have not been studied.

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 Cushing's syndrome with any local GCS. In children, the area of the skin, on which the Monovo cream is applied, should not exceed 10% of the surface area of the body.

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.

Application in the elderly

No special dose adjustment is required for older patients. It is impossible to exclude more frequent cases of hypersensitivity to the drug in this age category.

Side effects:

Local reactions: irritation and dry skin, burning sensation, itching, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, signs of skin atrophy, striae, sweat, papular or pustular rash, paresthesia.

The likelihood of these adverse events increases with the use of occlusive dressings.

System Action: when external forms of SCS are used for a long time (more than 3 weeks) and / or when applied to 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, , characteristic of the systemic action of GCS, including adrenal insufficiency and Isenko-Cushing syndrome.

Against the background of treatment with SCS, the process of wound healing can be slowed down.

Overdose:

Symptoms

Excessive or prolonged local application of GCS may be accompanied by oppression of the hypothalamic-pituitary-adrenal system, including secondary adrenal insufficiency.

Treatment

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

Interaction:Information on the drug interaction of the drug Monovo is absent.

Special instructions:

Care should be taken when applying to the skin of the face and areas of diaper rash, when using occlusive dressings,as well as when applied to large areas of the skin (more than 20% of the body surface area) and / or long-term treatment (more than 3 weeks), especially in children.

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. In children, it develops more rapidly (suppression of the hypothalamic-pituitary-adrenal system, reduced elimination of STH). 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. It is necessary to regularly monitor the function of the adrenal glands.

You should avoid getting the cream of Monova in your eyes.

Cetostearyl alcohol and cetyl alcohol included in the preparation may cause irritation at the site of application (contact dermatitis). In such cases, you should stop the application of Monovo Cream and prescribe the 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.When joining a secondary infection, antimicrobial therapy should be used.

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 it is completely discontinued.

Effect on the ability to drive transp. cf. and fur:Monovo Cream does not affect the ability to drive vehicles and mechanisms.

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

Packaging:

10, 15, 20, 25, 30, 50, 60 and 100 g in laminated tubes, sealed with a screwed polypropylene cap.

1 tuba together with instructions for use in a cardboard bundle.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Shelf life of the drug after the first opening of the tube is 6 months.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001061

Date of registration:27.10.2011 / 11.09.2012

Expiration Date:27.10.2016

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

Manufacturer: & nbsp

ALMIRALL HERMAL GmbH Germany

Representation: & nbspRAYFARM, LLCRAYFARM, LLC

Information update date: & nbsp13.06.2018

Illustrated instructions

Instructions

Monovo (Monovo)