Hoe Pharma/Taisho Pharmaceutical


Zuellig Pharma
Full Prescribing Info
Mometasone furoate.
Each gram of cream contains mometasone furoate 0.1% w/w with methyl paraben 0.08% w/w and propyl paraben 0.02% w/w as preservative.
Excipients/Inactive Ingredients: Monobasic sodium phosphate, phosphoric acid, cetomacrogol 1000, propylene glycol, white soft paraffin, liquid paraffin, cetostearyl alcohol, and purified water.
Each gram of ointment contains mometasone furoate 0.1% w/w.
Excipients/Inactive Ingredients: White soft paraffin and liquid paraffin.
Each mL of lotion contains mometasone furoate 0.1% w/v with methyl paraben 0.1% w/v as preservative.
Excipients/Inactive Ingredients: Hydroxypropyl methylcellulose, isopropyl alcohol, phosphoric acid, and purified water.
Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic and vasoconstrictive properties.
Pharmacology: Corticosteroids diffuse across cell membranes and bind with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various inhibitory enzymes responsible for the anti-inflammatory effects of topical corticosteroid. Mometasone is only minimally absorbed after topical application and the onset of action is rapid.
Cream and Ointment: Indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Lotion: Indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, which includes scalp lesions.
Dosage/Direction for Use
Cream and Oinment: A thin film should be applied to the affected skin areas once daily until lesion heals or for duration of three weeks, whichever is sooner as directed by the doctor or pharmacist.
Lotion: Apply a few drops to affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears.
Symptoms and Treatment: Corticosteroid applied to the skin can be absorbed in sufficient amounts to produce systemic effects such as hypothalamic-pituitary-adrenal axis suppression, manifestation of Cushing's Syndrome, hyperglycaemia and glycosuria. Tests which may be helpful in evaluating hypothalamic-pituitary-adrenal axis suppression include urinary free cortisol test and ACTH stimulation test. If hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or a weaker steroid used. Supplemental systemic corticosteroid may be required if signs and symptoms of steroid withdrawal occurs.
Elosone is contraindicated in patients who are sensitive to Mometasone Furoate or to other corticosteroids or to any component of these preparations. Risk vs. benefit should be considered when the following medical problems exist: allergy to corticosteroids, infection at treatment site, skin atrophy, cataracts, diabetes mellitus, glaucoma and tuberculosis.
Special Precautions
If irritation or sensitization develops with the use of Elosone, 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 favourable 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 occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's Syndrome than mature patients because of a larger skin surface area to body weight ratio. Use of topical corticosteroid in children should be limited to the least amount compatible with an effective therapeutic regiment. Chronic corticosteroid therapy may interfere with growth and development of children. Elosone is not for ophthalmic use.
Adverse Reactions
Local adverse reactions reported very rarely with Elisone Cream 0.1% w/w include paresthesia, pruritus and signs of skin atrophy. Local adverse reactions rarely reported with Elosone Ointment 0.1% w/w include burning, pruritus, tngling/stinging and signs of skin atrophy. Local adverse reactions reported very rarely with Elosone lotion 0.1% w/v 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.
Drug Interactions
Keep container well closed. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
In-use shelf life: 28 days at or below 30°C.
ATC Classification
D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Cream (white) 0.1% x 15 g. Oint (white) 0.1% x 15 g. Lotion (slightly viscous solution) 0.1% x 30 mL.
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