Ikaflam

Ikaflam

mometasone

Manufacturer:

Ikapharmindo
Full Prescribing Info
Contents
Mometasone furoate.
Description
Each gram of cream contains: Mometasone furoate 1 mg.
Action
Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic and vasoconstrictive properties.
Indications/Uses
IKAFLAM cream indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.
Dosage/Direction for Use
A thin film of IKAFLAM cream should be applied to the affected skin areas once daily. Do not use occlusive dressing.
Overdosage
Symptoms: Excessive, prolonged use of topical corticosteroid 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
IKAFLAM cream is contraindicated in any patients who are sensitive to mometasone furoate, to other corticosteroid or to any component of these preparations.
Special Precautions
If irritation or sensitization develops with the use of IKAFLAM 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.
Corticosteroid therapy can be used if therapy with less toxic drugs is not effective.
IKAFLAM cream are not for ophthalmic use.
Use in Pregnancy & Lactation: Since safety of Mometasone furoate product 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 patient 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 Pregnancy & Lactation
Usage during Pregnancy and in Nursing Women: Since safety of Mometasone furoate product 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 patient 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 IKAFLAM cream include paresthesia, pruritus and signs of skin atrophy.
The following local adverse reaction have been reported infrequently with the use of other topical corticosteroids: Burning, pruritus, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruption, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Storage
Store Below 30°C.
Do not use more than 3 months after the packaging is opened.
ATC Classification
D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Cream (tube) 0.1% x 5 g x 1's, 10 g x 1's.
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