OLMESONE
-
Chemical Name:
MOMETASONE FUROATE -
Therapeutic Category:
Anti-inflammatory drugs -
Pharmacologic Category:
Corticosteroid, Topical -
Pharmaceutical Form:
Cream -
Composition:
MOMETASONE FUROATE 1 MG
OLMESONE
Cream
Mometasone Furoate
1-PHARMACOLOGY:
Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory antipruritic and vasoconstrictive properties.
2-INDICATIONS:
OLMESONE is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.
3-CONTRAINDICATIONS:
Mometasone furoate Cream, is contraindicated in patients who are sensitive to it, to other corticosteroids or to any component of these preparations.
4-PRECAUTIONS:
If irritation or sensitization develops with the use of Mometasone furoate products, treatment should he discontinued and appropriate therapy instituted.
In the presence of an infection, use of an appropriate antifungal or antibacterial agent should be instituted if a favorable response does not occur promptly, the corticosteroid should he discontinued until the infection is controlled adequately.
Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially is infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use in anticipated, particularly in infants and children.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with growth and development of children.
Since safe use of Mometasone furoate products in pregnant women has not been established, topical corticosteroids should be used during pregnancy only if the potential benefit justifies potential risk to the fetus. Drugs of this class should not be used on pregnant patients in large amounts or for prolonged periods of time. It is not known whether topical administration of corticosteroids could result insufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue raising nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excessive, prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency. Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.
OLMESONE products are not for ophthalmic use.
5-ADVERSE REACTIONS:
Local adverse reactions reported very rarely with Mometasone furoate Cream 0.1% include paresthesia, pruritus and signs of skin atrophy.
The following local adverse reactions have been reported infrequently with the use of other topical corticosteroids: Irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.
6-DOSAGE AND ADMINISTRATION:
A thin film of OLMESONE Cream 0.1% should be applied to the affected skin areas once daily.
Massage gently and thoroughly until the medication disappears.
7-PACKAGING AND COMPOSITION:
OLMESONE – Cream: A pack of aluminium tube of 20 g. Each 1g of the cream contains Mometasone Furoate 1 mg (0.1%).
8-STORAGE CONDITIONS:
Store OLMESONE – Cream at temperature between (15-30)°C.