Composition, form of production and packaging
Cream for external use 0.1% white or almost white.
1 g
mometasone furoate 1 mg
Excipients: hexylene glycol, glyceryl monostearate 40-55, cetostearyl alcohol, macrogol 20 cetyl stearate, white wax, titanium dioxide, starch, octenyl succinate, phosphoric acid, diluted, white petrolatum, purified water.
15 g - aluminum tubes (1) - cardboard packs.
30 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
GCS for external use. Has anti-inflammatory, antipruritic, antiexudative action.
Mometasone (like other GCS) induces the release of proteins that inhibit phospholipase A 2 and are 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
With external use of Uniderm В® cream, absorption is negligible. 8 hours after application to the intact skin (without occlusive dressing), about 0.4% of the active substance is found in the systemic circulation.
INDICATIONS
- inflammatory symptoms and itching with dermatoses that are amenable to GKS therapy.
DOSING MODE
The drug is used externally.
A thin layer of Uniderm В® cream is applied to the affected areas of the skin 1 time / 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 EFFECT
Dermatological reactions: rarely - irritation and dry skin, burning sensation, itching, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, skin maceration, secondary infection, signs of skin atrophy, striae, sweating; <1% - the formation of papules, pustules.
Allergic reactions: allergic contact dermatitis.
Other: when using Uniderm В® cream 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, there may be side effects characteristic of systemic SCS, including adrenal insufficiency and Cushing's syndrome.
CONTRAINDICATIONS
- rosacea;
- perioral dermatitis;
- bacterial, viral (caused by Herpes simplex types 1 and 2, Varicella zoster) or fungal skin infections;
- tuberculosis;
- syphilis;
- postvaccinal reactions;
- Children's age up to 6 months;
- Pregnancy (treatment of extensive skin areas, long-term treatment);
- lactation period (use in high doses and / and for a long time);
- Hypersensitivity to the components of the drug or to the SCS.
Caution should be applied to the skin on the face and skin folds, with occlusive dressings, as well as when applied to large areas of the skin and / or long-term treatment (especially in children older than 6 months).
PREGNANCY AND LACTATION
The safety of the use of Uniderm В® cream in pregnancy and lactation has not been studied.
GCS penetrate the placental barrier. When pregnancy should avoid prolonged treatment and use of the drug in high doses in connection with the threat of adverse effects on the development of the fetus.
GCS is excreted in breast milk. In the case where the use of the drug in high doses and / or for a long time is expected, breastfeeding should be stopped.
APPLICATION FOR CHILDREN
The safety and efficacy of Uniderm В® cream in topical application in children older than 6 months for a period exceeding 6 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 in the application of any GCS for external and topical application.
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. In children aged 6 months to 2 years, the course of treatment should not exceed 5 days.
Contraindication: children under 6 months.
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 monitored to identify symptoms of suppression of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome.
UnidermВ® cream should be avoided in the eye.
Propylene glycol, which is part of the preparation, may cause irritation at the site of application. In such cases, the use of Uniderm В® cream should be discontinued and appropriate treatment should be prescribed.
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 GCS, 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 withdrawal of the Uniderm В® preparation should be carried out gradually, for example, by switching to an intermittent treatment regimen before it is completely discontinued.
Use in Pediatrics
The safety and efficacy of Uniderm В® cream in topical application in children older than 6 months for a period exceeding 6 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 in the application of any GCS for external and topical application.
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. In children aged 6 months to 2 years, the course of treatment should not exceed 5 days.
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).
DRUG INTERACTION
There is no data on the interaction of Uniderm В® cream with other medicinal products.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 2 years.
