Elosone

Mometasone furoate.

Contains Mometasone Furoate 0.1% w/w.
Excipients/Inactive Ingredients: Elosone Cream: Other excipients are Methylparaben, Propylparaben, Monobasic Sodium Phosphate, Phosphoric Acid, Cetomacrogol 1000, Propylene Glycol, White Soft Paraffin, Liquid Paraffin, Cetostearyl Alcohol and Purified Water.
Elosone Ointment: Other excipients are White Soft Paraffin and Liquid Paraffin.

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.

Elosone Cream & Ointment 0.1% w/w - Indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

RECOMMENDED DOSAGE: 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.
ROUTE OF ADMINISTRATION: Topical.

SYMPTOMS AND TREATMENT FOR OVERDOSE AND ANTIDOTE(S): 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 If hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or a weaker steroid used.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.

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.
Visual disturbance may be reported with systemic and topical 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 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.

Local adverse reactions reported very rarely with Elosone Cream 0.1% w/w include paresthesia, pruritus, signs of skin atrophy and blurred vision. Local adverse reactions rarely reported in Elosone Ointment 0.1% w/w include burning, pruritus, tingling/stinging 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.

Unknown.

Keep container well closed. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.

Topical Corticosteroids

D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.

POM