ELOMET Cream Ref.[50350] Active ingredients: Mometasone

If irritation or sensitization develops with the use of ELOMET Cream treatment should be 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 be 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 in 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 is 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.

Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

ELOMET Cream is not for ophthalmic use.

No known data.

Since safe use of ELOMET Cream 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 in sufficient 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 nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Local adverse reactions reported very rarely with ELOMET 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.

Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.

No known data.