Momat With
Producer: Glenmark Pharmaceuticals Ltd. (Glenmark Pharmasyyutikalz Ltd) India
Code of automatic telephone exchange: D07XC03
Release form: Soft dosage forms. Ointment.
General characteristics. Structure:
Active agents: a mometazona furoate – 0,1 g, salicylic acid - 5,0g.
Excipients: vaseline (white vaseline), white beeswax, propylene glycol monostearate, hexyleneglycol.
Pharmacological properties:
Pharmacodynamics. Pharmakodinamichesky properties of Momat-S ointment are directly connected with availability of active components, a mometazon of furoate and salicylic acid.
Mometazona furoate is a strong glyukokorgikosteroid. As well as other glucocorticosteroids of topical administration, a mometazon furoate has antiinflammatory, antipruritic and vasoconstrictive properties. The glucocorticosteroid induces release of the proteins inhibiting a phospholipase of A2 and known under the general name of a lipokortina. These proteins control biosynthesis of such strong mediators of an inflammation as prostaglandins and leukotrienes, by braking of release of their common precursor, arachidonic acid. Arachidonic acid is emitted from membrane phospholipids under the influence of A2 phospholipase.
In experiences of in vitro it was shown that the mometazona furoate is a powerful inhibitor of synthesis of three cytokines participating in origin of inflammatory process and its maintenance: interleykina-1 (IL-1), interleykina-6 (IL-6) and alpha factor of a necrosis of tumors (ФНО-α).
Salicylic acid causes peeling of a corneous layer of skin and, at the same time, does not lead to qualitative or quantitative changes in structure of viable epidermis. This mechanism of action is explained with dissolution of intercellular binding substance.
Pharmacokinetics. Absorption. After single local putting the ointment containing a mometazon furoate (0,1%) in a combination with salicylic acid (5%) for 12 hours without occlusive bandage on the injured skin, system absorption about 1,5% of the applied dose was revealed. The average content of salicylic acid in a maximum made 0,0908 mg/dl in plasma. System toxic reactions to presence of salicylic acid usually connect with much higher levels in plasma (30-40 mg/dl).
Metabolism.
The furoate absorbed a mometazona quickly is metabolized with formation of the various metabolites which are more polar compounds than initial substance. Metabolites have no pharmacological activity. The main metabolites of salicylic acid which are quantitatively defined in plasma after topical administration of Momat-S ointment is a gentisic acid (Cmax = 0,00127 mg/dl in 24 h) and salitsilurovy acid (Cmax = 0,0171 mg/dl in 3,3 h).
Removal.
It is removed, mainly, by kidneys and in insignificant quantity with bile.
Indications to use:
Psoriasis.
Route of administration and doses:
Outwardly. A thin film of ointment should be applied on affected areas of skin twice a day, in the morning and in the evening; the maximum daily dose makes 15 g.
Features of use:
As well as at use of all glucocorticosteroid drugs, it is necessary to take the appropriate measures of precaution in case of putting ointment on big sites of skin or intended long use. This prevention is especially important in pediatrics. Because the ratio of a surface of skin and body weight at children is higher, than at adults, children can show higher sensitivity to action of glucocorticosteroids, than adults, with the advent of suppression signs at them гипоталамо - pituitary and adrenal system and to manifestation of a syndrome of Cushing.
Ointment is not recommended to be used with occlusive bandages, including diapers and pampers. Drug is not intended for drawing on the person or in a groin and axillary hollows. Ointment is not subject to use in ophthalmology. Children have to receive the minimum quantity of glucocorticosteroids necessary for achievement of effect. Long therapy using glucocorticosteroids can make undesirable impact on growth and development of children.
In case of irritation, including the excessive xeroderma and at emergence of allergic reactions should stop use of Momat-S ointment and to appoint the corresponding treatment.
If the accompanying skin infection develops, it is necessary to use necessary antifungal or antibacterial agent. If affirmative answer on treatment is not reached quickly, use of Momat-S ointment should be interrupted until until the infection is properly eliminated. It is necessary to estimate risk and the expected effect of use of Momat-S ointment in case of existence of the following diseases: diabetes mellitus, defeat or inflammation of peripheral vessels, irritation or infection of skin. Glucocorticosteroids can cause change of outward of affected areas of skin that complicates statement of the correct diagnosis and leads to recovery delay.
Impact of drug on ability to drive the car and other mechanisms is not revealed.
Side effects:
In general Momat-S ointment when drawing twice a day is well transferred. The most often found side effects are: weak or moderate burning on site putting ointment, itch, peeling.
From among noted side effects at use of local glucocorticosteroids on the big surfaces of skin it is possible to mention the following: irritation, maceration of skin, xeroderma, folliculitis, acne rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis, emergence of atrophic strips of skin, heat rash, consecutive infections, hypertrichosis. At children function suppression гипоталамо - pituitary and adrenal system with development of a syndrome of Cushing is possible.
Interaction with other medicines:
At topical administration of Momat-S ointment presence of very small, but measurable amounts of salicylates at a blood plasma was observed. According to the published data on interaction of salicylates with other substances after intake or drawing on skin, change of action of the following medicinal connections is possible: Tolbutamidum (Butamidum), a methotrexate, heparin, Pyrazinamidum, means promoting removal of uric acid, and drugs of indirect anticoagulants. Other glucocorticosteroids and ammonium sulfate can influence the content of salicylic acid. The specified interactions should be meant at purpose of Momat-S ointment together with these connections.
Contraindications:
Momat-S ointment is contraindicated to patients with hypersensitivity to a mometazon to furoate, salicylic acid or to any other component of drug. As well as other glucocorticosteroids of topical administration, Momat-S ointment it is not shown for use by the patients suffering bacterial virus (a virus of a herpes simplex, chicken pox, shingles) or fungal infections of skin. Drug should not be used at treatment of pink eels or perioral dermatitis. Besides, Momat-S ointment is contraindicated at treatment of manifestations of postvaccinal reactions, tuberculosis and syphilis. Drug use is not recommended to children up to 12 years, to women during pregnancy and a lactation.
With care
At inflammatory diseases, including peripheral vessels, irritation or infectious damage of skin and for the patients receiving high doses of salicylates (for example, at a pseudorheumatism), patients with a diabetes mellitus, glaucoma and a cataract.
Overdose:
Long use of locally put glucocorticosteroids in excess quantities can lead to suppression гипоталамо - pituitary and adrenal system and to secondary insufficiency of adrenal glands. If suppression гипоталамо - pituitary and adrenal system is observed, then it is necessary to stop use of ointment or to reduce the frequency of drawings.
In case of the toxicity caused by salicylic acid, use of Momat-S ointment should be stopped. For stimulation of a conclusion of salicylates with urine it is necessary to enter liquids. As required it is possible to appoint peroral or intravenous administration of sodium bicarbonate and salts of potassium.
Storage conditions:
At a temperature not above 25 °C.
Not to freeze.
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
Ointment for external use. On 10 g and 15 g in the aluminum varnished tubas having a nozzle with the closed end with the cover having an edge for piercing. One tuba together with the application instruction is located in a cardboard pack.