ELOCOM
Schering
Mometasone Furoate
Corticosteroid
Action And Clinical Pharmacology: Mometasone has anti-inflammatory, antipruritic and vasoconstrictive actions. The exact mechanism, however, of corticosteroids in each disease is uncertain. Mometasone has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Indications And Clinical Uses: For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as psoriasis and atopic dermatitis. The lotion formulation may be applied to scalp lesions.
Contra-Indications: Hypersensitivity to any one of the components is a contraindication to its use. Topical steroids are contraindicated in untreated fungal, bacterial and viral (i.e. herpes simplex, chickenpox and vaccinia) infections involving the skin.
Manufacturers’ Warnings In Clinical States: Children: 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 HPA 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.
The lotion contains isopropyl alcohol and may cause stinging or burning upon application to abraded or sun-burned skin. Do not use in or near the eyes.
Precautions: Geriatrics: Suitable precautions should be taken in using topical glucocorticoids in patients with impaired circulation suffering from stasis dermatitis and other skin diseases.
Pregnancy and Lactation: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Patients should be advised to inform subsequent physicians of the prior use of glucocorticoids.
If irritation, sensitization, excessive dryness develop with the use of mometasone, treatment should be discontinued.
Although mometasone is poorly absorbed, nevertheless, application of corticosteroids over extensive lesions, or exceeding the dosage schedule may result in significant systemic absorption producing hypercortisonism manifesting itself by adrenal suppression, moon facies, striae and suppression of growth.
During the use of topical corticosteroids, infections may occur. If an overt infection is present, appropriate antimicrobial treatment is indicated. If symptomatic response is not noted within a few days to a week, the local application of corticosteroids should be discontinued and the patient re-evaluated.
Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or s.c. tissues. If this occurs, treatment should be discontinued.
Mometasone is not formulated for ophthalmic use and should not be used in or near the eyes.
Adverse Reactions: The following local adverse reactions have been reported: Cream: During clinical studies in 319 patients: burning – 1, pruritus – 1, skin atrophy – 3. Ointment: During clinical studies in 812 patients: burning – 13, pruritus – 8, skin atrophy – 8, tingling/stinging – 7, and furunculosis – 3. Lotion: During clinical studies in 457 patients: burning – 9 (2%), pruritus – 4 (1%), skin atrophy – 6 (2%) (shininess, thinness, striae, telangiectasia).
The following local adverse reactions have been reported infrequently when other topical dermatologic corticosteroids have been used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.
Cream: The overall incidence of side effects was 1.6%, i.e. 5 of 319 subjects and patients reported treatment-related adverse experiences.
Ointment: The overall incidence of side effects was 4.9%, i.e. 40 of 812 subjects reported treatment-related adverse experiences.
Lotion: The overall incidence of side effects was 5.1%, i.e. 31 of 613 subjects and patients reported treatment-related adverse experiences.
Side effects were mild to moderate and were those typically associated with topical corticosteroid formulations after 7 days of treatment.
No systemic treatment-related adverse experiences were seen.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: No specific antidote is available and treatment should be symptomatic.
Percutaneous absorption of corticosteroids can occur when large amounts of corticosteroids are applied. Toxic effects may include ecchymosis of skin, peptic ulceration, hypertension, aggravation of infection, hirsutism, acne, edema and muscle weakness due to protein depletion. Treatment of a patient with systemic toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation using oxygen and assisted or controlled respiration as required. This will be sufficient in the management of most reactions. Should circulatory depression occur, vasopressors such as ephedrine or metaraminol and i.v. fluids may be used. Should a convulsion persist despite oxygen therapy, small increments of an ultra-short acting barbiturate (pentobarbital or secobarbital) may be given i.v. Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.
Dosage And Administration: Cream/Ointment: Apply a thin film to the affected skin areas once daily.
Lotion: Apply a few drops of the lotion to the affected skin areas including scalp sites once daily; massage gently and thoroughly until medication disappears.
Do not use occlusive dressings.
Availability And Storage: Cream: Each g of white to off-white uniform cream contains: mometasone furoate 1 mg. Nonmedicinal ingredients: aluminum starch octenylsuccinate, ceteareth-20, hexylene glycol, phosphoric acid, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum and white wax. Tubes of 15 and 50 g. Store between 2 and 30°C.
Lotion: Each g of lotion contains: mometasone furoate 1 mg. Nonmedicinal ingredients: hydroxypropylcellulose, isopropyl alcohol, phosphoric acid to adjust pH, propylene glycol, purified water and sodium phosphate monobasic. Plastic bottles of 30 and 75 mL. Store between 2 and 30°C.
Ointment: Each g of ointment contains: mometasone furoate 1 mg. Nonmedicinal ingredients: hexylene glycol, phosphoric acid to adjust pH, propylene glycol stearate, purified water, white petrolatum and white wax. Tubes of 15 and 50 g. Store between 2 and 30°C.
ELOCOM Schering Mometasone Furoate Corticosteroid
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