Elicort

Elicort

mometasone

Manufacturer:

Dongkwang Pharm

Distributor:

Endure Medical
Full Prescribing Info
Contents
Mometasone furoate.
Description
Each gram contains Mometasone (as furoate) 1 mg.
Indications/Uses
Mometasone furoate is used for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Dosage/Direction for Use
Apply to affected area in thin layers, by smoothing gently into the skin preferably after a bath once daily or as prescribed by the physician. A "steroid holiday" of at least 2 weeks should be considered in children after each 2 or 3 weeks of daily topical therapy to allow thinned epidermis to restore itself and maintain its barrier function.
Contraindications
Contraindicated in the presence of acute infections uncontrolled by appropriate antimicrobial therapy, ulcerative conditions, rosacea, pruritus, children less than one (1) year of age and in patients with hypersensitivity to the drug or any of its components.
Special Precautions
Avoid contact with the eyes. Should not be applied with an occlusive dressing to large areas of the body. Long-term topical use is best avoided, especially in children. Patients already receiving corticosteroids are more susceptible to infection, the symptoms of which, moreover, may be masked until an advanced stage has been reached. Discontinue if sensitization of irritation develops.
Use in pregnancy and lactation: Mometasone furoate is a pregnancy category C medication. During pregnancy and lactation treatment with mometasone furoate should be performed only on the physician's order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with mometasone furoate in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. Like other topically applied glucocorticoids, mometasone furoate should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or foetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breastmilk.
Mometasone furoate should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breastfeeding should be discontinued.
Adverse Reactions
Adverse effects of Mometasone are the following: Burning, folliculitis, paresthesia, acneiform reaction, pruritus, loss of skin collagen and subcutaneous atrophy, local hypopigmentation of deeply pigmented skins, hypersensitivity reactions, mobilization of calcium and phosphorus, with osteoporosis and spontaneous fractures; muscle wasting and nitrogen depletion; and hyperglycemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased. Increased appetite is often reported. Impaired tissue repair and immune function can lead to delayed wound healing, and increased susceptibility to infection. Increased susceptibility to all kinds of infection, including septicemia, tuberculosis, fungal infections, and viral infections, has been reported in patients on corticosteroid therapy. Infections may also be masked by the anti-inflammatory, analgesic, and antipyretic effects of glucocorticoids. The increased severity of varicella and measles may lead to a fatal outcome in non-immune patients receiving systemic corticosteroid therapy. Other adverse effects include menstrual irregularities, amenorrhoea, hyperhidrosis, skin thinning, ocular changes including development of glaucoma and cataract, mental and neurological disturbance, benign intracranial hypertension, acute pancreatitis, and avascular necrosis of bone. An increase in the coagulability of the blood may lead to thromboembolic complications. Peptic ulceration has been reported but reviews of the literature do not always agree that corticosteroids are responsible for an increased incidence. Adverse effects should be treated symptomatically, with the corticosteroid dosage reduced or slowly withdrawn where possible.
Drug Interactions
Concurrent use of barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids.
Conversely, oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. Use of corticosteroids with potassium-depleting diuretics, such as thiazides or furosemide, may cause excessive potassium loss. There is also an increased risk of hypokalemia with concurrent amphotericin B or bronchodilator therapy with xanthines or beta2 agonist. There may be an increased incidence of gastrointestinal bleeding and ulceration when corticosteroids are given with non steroidal anti-inflammatory drugs. Response to anticoagulants may be altered by corticosteroids and requirements of antidiabetic drugs and antihypertensive may be increased. Corticosteroids may decrease serum concentrations of salicylates and may decrease the effect of anticholinesterases in myasthenia gravis.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Cream 0.1% x 5 g, 10 g. Oint 0.1% x 10 g x 1's.
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