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  • Elocom
    / MSD


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cream

    15 g

    not in the basket chart 9194 5054

    Ointment

    15 g

    not in the basket chart 9183 5052

    Lotion

    20 ml

    not in the basket chart 82906 5492

    Dosage

    Apply a thin film of mometasone furoate cream of ointment or a few drops of mometasone furoate lotion to the affected skin areas once daily.            


    Indications

    Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis, atopic dermatitis.


    Contra-Indications

    Mometasone fuorate is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. This product should not be used on wounds or on skin which is ulcerated. Mometasone fuorate should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the ingredients in this medicine.


    Special Precautions

    If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of a dermatological infection, use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
    Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
    Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.
    As the safety and efficacy of Mometasone fuorate in pediatric patients below 2 years of age have not been established, its use in this age group is not recommended. Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.
    Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.
    As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment. Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing. Mometasone fuorate cream, ointment and lotion contains propylene glycol which may cause skin irritation.
    Mometasone fuorate topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.


    Side Effects

    Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: skin dryness irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
    Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced hypothalamic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Chronic corticosteroids therapy may interfere with the growth and development of children.
    See prescribing information for full details.


    Drug interactions

    None known.


    Pregnancy and Lactation

    Pregnancy: There is inadequate evidence of safety in human pregnancy. However as with all topically applied glucocorticoids, the possibility that fetal growth may be affected by glucocorticoid passage through the placental barrier should be considered.
    Like other topically applied glucocorticoids, Elocom should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the fetus.
    Lactation: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Mometasone fuorate should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast-feeding should be discontinued.
    See prescribing information for full details.


    Overdose

    Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function, resulting in secondary adrenal insufficiency which is usually reversible.
    If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
    The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.


    Important notes

    Storage: Store below 25°C.
    Ointment: After first opening, use within 1 month.
    Lotion and cream: After first opening, use within 3 months.


    Manufacturer
    Schering-Plough Labo N.V., Belgium
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