Motaderm® Cream 0.1%, each gram contains : Mometasone furoate 1 mg.
Motaderm® with Mometasone furoate as its active ingredient is available in 0.1% cream.
For the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatosis, such as psoriasis and atopic dermatitis.
DOSAGE AND ADMINISTRATION :
A thin film of Motaderm® Cream should be applied to the affected skin areas once daily. Do not use occlusive dressing.
- 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 case of chronic toxicity, slow withdrawal of corticosteroids is advised.
Patients who are hypersensitive to Mometasone furoate, to other corticosteroids or to any component of these preparations.
WARNINGS AND PRECAUTIONS :
- If irritation or sensitization develops with the use of Mometasone furoate, 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 Mometasone furoate should be discontinued until the infection is controlled adequately.
- Avoid long term uses, on wide surface of the body and using addessive.
- Since safe use of Mometasone furoate in pregnant and nursing women has not been established, therefore the advantages and disadvantages should be considered.
- 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. 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.
- Mometasone furoate cream is not for ophthalmic use.
- Usage during pregnancy and in nursing women : Since safe use of Mometasone furoate product in pregnant woman 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. Systematically 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 drug, taking into account the importance of the drug to the mother.
ADVERSE REACTIONS :
- Very rarely : Paresthesia, pruritus and sign of skin atrophy.
- The following local adverse reactions have been reported infrequently with the use of other topical corticosteroids : Burning, pruritus, irritation, dry skin, folliculitis, hypertrichosis, akneiform eruption, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Motaderm® Cream 0.1% Box, 1 tube @ 10 g Reg. No. DKL0002330529A1
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia