Elica

Elica

mometasone

Manufacturer:

Bayer

Distributor:

Zuellig
Full Prescribing Info
Contents
Mometasone furoate.
Description
Each g of Elica cream contains mometasone furoate 1 mg. It also contains the following excipients: White petrolatum, white wax, propylene glycol stearate, stearyl alcohol and ceteareth-20, hexylene glycol, titanium dioxide, aluminum starch octenylsuccinate, purified water and phosphoric acid to adjust the pH.
Each g of Elica ointment contains mometasone furoate 1 mg. It also contains the following excipients: Hexylene glycol, white wax, propylene glycol stearate, white petrolatum, purified water and phosphoric acid to adjust the pH.
Each g of Elica lotion contains mometasone furoate 1 mg. It also contains the following excipients: Isopropyl alcohol, hydroxypropyl cellulose, sodium phosphate monobasic monohydrate, propylene glycol, purified water and phosphoric acid if needed, to adjust the pH.
Action
Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic and vasoconstrictive properties.
Indications/Uses
Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses eg, psoriasis and atopic dermatitis.
Elica lotion may be applied to scalp lesions.
Dosage/Direction for Use
A thin film of Elica cream or ointment should be applied to the affected skin areas once daily.
Apply a few drops of Elica lotion to affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears.
Overdosage
Symptoms: Excessive, prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency.
Treatment: 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.
Contraindications
Patients who are sensitive to mometasone furoate, to other corticosteroids or to any component of these preparations.
Special Precautions
If irritation or sensitization develops with the use of Elica products, 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.
Elica products are not for ophthalmic use.
Use in pregnancy & lactation: Since safe use of Elica 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 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.
Use in 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.
Use In Pregnancy & Lactation
Since safe use of Elica 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 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.
Adverse Reactions
Local adverse reactions reported very rarely with Elica cream include paresthesia, pruritus and signs of skin atrophy.
Local adverse reactions rarely reported with Elica ointment include burning, pruritus, tingling/stinging and signs of skin atrophy.
Local adverse reactions rarely reported with Elica lotion include burning, folliculitis, acneiform reaction, 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.
Storage
Store at temperature not exceeding 30°C.
MIMS Class
Topical Corticosteroids
ATC Classification
D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Lotion:Rx;Cream/Oint:Non-Rx
Presentation/Packing
Lotion 0.1% x 30 mL. Cream 0.1% x 5 g. Oint 0.1% x 5 g.
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