Expiration date: 03/2025
The composition and form of issue:
Cream 1g contains:
mometasone furoate 1 mg
excipients: phosphoric acid gexilenglikole propilenglikolstearat cetylstearyl stearyl alcohol ether, cetearate-20 titanium dioxide aluminum octenylsuccinate obtained from starch white wax white petrolatum purified water
in the box to 15 grams in a cardboard box 1 tuba.
Ointment 1g contains:
mometasone furoate 1 mg
excipients: gexilenglikole phosphoric acid propylene glycol stearate, white wax, white petrolatum purified water
in the box to 15 grams in a cardboard box 1 tuba.
Lotion 1ml contains:
mometasone furoate 1 mg
excipients: 40% isopropyl alcohol propylene glycol hydroxypropyl cellulose sodium phosphate water. May also contain phosphoric acid and sodium hydroxide to establish a pH value approximately equal to 4.5
in vials of 20 ml in a cardboard box 1 vial.
Lotion 1 ml contains:
mometasone furoate 1 mg
excipients: 40% isopropyl alcohol propylene glycol hydroxypropyl cellulose sodium dihydrogen phosphate dihydrate purified water phosphoric acid or sodium hydroxide (to determine the pH value, approximately equal to 3,5–5,5 )
in dropper bottle of 20 ml in a cardboard box 1 vial.
Pharmacological action:
The mechanism of action appears to be associated with the induction of the isolation of proteins inhibiting phospholipase A2 and is known under the name lipokortina. These proteins are assumed to control the biosynthesis of these potent inflammatory mediators like PG and LT, by inhibiting release of their common precursor arachidonic acid.
Carcinogenesis, mutagenesis. In studies of the genetic toxicity of mometasone furoate, including test Ames test mouse lymphoma and micronucleus test, there were no signs of a mutagenic effect of the drug.
Long-term animal studies to evaluate carcinogenic effects of the drug were not conducted.
Pharmacokinetics:
The degree of penetration of corticosteroids topical application through the skin depends on many factors, including the composition of the drug and the integrity of the epidermal barrier. Inflammation and other processes occurring in the skin, can lead to increased penetration of the drug through the skin. After a single topical application to intact skin (without occluzionna bandages) approximately 0.7% of the dose of ointment and about 0.4% cream found in the blood after 8 h There is reason to believe that the level of absorption of glucocorticosteroid dosage forms lotion is also negligible.
Indications:
The weakening and elimination of inflammation and pruritus in dermatoses amenable glucocorticosteroid therapy in adults and children aged 2 years.
Contraindications:
Hypersensitivity.
Application of pregnancy and breast-feeding:
Adequate, well-controlled studies of the teratogenic potential of mometasone furoate when administered during pregnancy was carried out. Use cream, ointment or lotion Elocom when pregnancy is possible only if the expected benefit in the treatment for mother will outweigh the potential risk to the fetus.
With systemic use of corticosteroids appear in breast milk, which can lead to slower growth child effect on endogenous synthesis of corticosteroids and other adverse effects. Evidence that systemic absorption of corticosteroids with local application may lead to the appearance of their designated quantities in breast milk. However, because many drugs are excreted in breast milk, lactating women should apply cream, ointment, lotion Elocom with caution.
Side effects:
Cream. In controlled clinical trials in 319 patients, the incidence of adverse effects associated with the use of the cream Elocom, was 1.6%. Was noted burning, itching, skin atrophy, there were reports about the appearance of rosacea. In controlled clinical studies in children aged 2 to 12 years (n=74) frequency of adverse events (burning, itching, abrasions) associated with the use of the cream was approximately 7%.
Ointment. In controlled clinical trials in 812 patients, the incidence of adverse events associated with the use of ointment Elocom, was 4.8%. Noted a burning sensation, tingling, itching, atrophy of the skin, furunculosis, there were reports about the appearance of rosacea. In controlled clinical studies in children aged 2 to 12 years (n=74) frequency of adverse events (burning, itching, abrasions) associated with the use of ointments was approximately 7%.
Lotion. In clinical studies on 209 patients were observed following adverse events: pain (4 cases), pustular rash (2 cases), pruritus (1 case). In the study, increased/painful sensitivity in 156 healthy volunteers noted the occurrence of folliculitis (4 cases).
The local application of glucocorticosteroid drugs can rarely cause the following adverse effects in order of decreasing frequency of occurrence — irritation and dryness, folliculitis, hypertrichosis, pustular rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of skin, secondary infection, striae and miliaria. The probability of occurrence of a listed adverse events increases with use of occlusive dressings.
Drug interactions:
The relevant data is not available.
Method of application and dose:
Local.
Elocom
Cream or ointment applied thinly to the affected skin 1 time a day.
The lotion and applied a few drops to affected skin 1 time per day after applying the lotion to RUB gently until the disappearance of it from the surface of the skin. For the most efficient and economical use of the drug it is necessary to bring the spout of the bottle close to the affected area of skin and gently squeeze the bottle.
Elocom Lotion
The lotion and applied a few drops to affected skin 1 time per day after applying the lotion to RUB gently until the disappearance of it from the surface of the skin. For the most efficient and economical use of the drug it is necessary to bring the spout of the bottle close to the affected area of skin and gently squeeze the bottle.
The duration of treatment is determined by its efficiency and tolerability by the patient, the presence and severity of side effects.
Overdose:
When applied topically in high doses the possible absorption of the drug in quantities sufficient for the manifestation of systemic side effects.
Precautions:
Cream, ointment, lotion Elocom shown only for dermatological use and is not intended for use in ophthalmology.
As a result of systemic absorption of the local application of different glucocorticosteroid preparations may occur reversible suppression function of the hypothalamic - pituitary-adrenal system and symptoms of glucocorticosteroid insufficiency after withdrawal of the drug. At patients by systemic absorption of corticosteroids when administered systemically can also develop Cushing's syndrome, hyperglycemia and glucosuria.
Patients who receive topical corticosteroids to treat large skin areas or under occlusive dressings should be periodically tested for the presence of signs of suppression function of the hypothalamic-pituitary-adrenal axis. This check can be performed by a test with the ACTH-stimulation, measurement of the morning cortisol content in the plasma and in other environments in addition to urine. In the case that the marked inhibition of the hypothalamic-pituitary - adrenal system should increase the interval between applications or you can use another less powerful glucocorticosteroid, or stop the drug. Restoration of function of the hypothalamic - pituitary-adrenal system usually occurs shortly after the abolition of local corticosteroids. Sometimes there may be signs and symptoms of glucocorticosteroid insufficiency, which requires additional corticosteroids systemic action, the description of which can be found in the annotations on these drugs.
The drug Elocom can be used in children 2 years of age, however, it should be borne in mind that the safety and efficacy of their use in children in the period longer than 3 weeks, has not been studied.
Due to the fact that in children the ratio of surface area and body weight more than adults, children are at greater risk of suppression function of the hypothalamic - pituitary-adrenal axis and Cushing's syndrome when applying any of glucocorticosteroid drugs local action. For this reason, children have a higher risk of adrenal insufficiency if you cancel a treatment with corticosteroids local action. For the treatment of local corticosteroids in children easier to occur atrophic changes in the skin until the appearance of atrophic lines. The risk of oppression of the hypothalamic-pituitary - adrenal system in children increases with the application of corticosteroids on the area of more than 20% of the body surface.
There are reports of the suppression function of the hypothalamic-pituitary - adrenal system, occurrence of Cushing's syndrome, growth retardation, delay in gaining body mass and intracranial hypertension in children the local application of different glucocorticosteroid preparations. Among the manifestations of adrenal insufficiency include low levels of cortisol in the plasma and the absence of response to ACTH-stimulation. Intracranial hypertension leads to bulging fontanelles, headaches, bilateral swelling of the optic nerve.
Ointment and cream Elocom should not be used for the treatment of dermatitis caused by wearing diapers.
Ointment, cream and lotion should not be used under occlusive dressings, unless prescribed by a physician. Ointment and cream should not be applied in children on the skin under a diaper or under waterproof shorts (the effect of occlusive dressings). Ointment and cream are not intended for use on the face or in the groin area and underarms.
If irritation occurs, the drug should be discontinued Elocom and assign appropriate treatment. Allergic contact dermatitis in the application of corticosteroids is usually diagnosed on the basis of treatment failure, which should be supported by conducting a skin test.
With the development of concomitant skin infections, use an appropriate antifungal or antibacterial agent. If a positive response to treatment is not reached quickly, the use of the drug should be suspended until infection.
As in the case of the use of other corticosteroids, the use of cream, ointment and lotion Elocom should be discontinued when healing. If within 2 weeks after start of treatment no improvement occurs, you may need to clarify the diagnosis.
