Melomet

Mometasone furoate.

Ingredient(s): Each gram contains: Mometasone Furoate 1 mg.
Excipients/Inactive Ingredients: Cream: Preservative(s): Each gram contains: Methyl Paraben 2 mg; Propyl Paraben 0.5 mg.

Pharmacotherapeutic group: Mometasone.
Pharmacology: Pharmacodynamics: Cream: Mometasone furoate, a synthetic corticosteroid, exhibits marked anti-inflammatory, antipruritic and vasoconstrictive properties. Although generally unclear, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.
Lotion: Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.
Pharmacokinetics: Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream and ointment 0.1% is minimal, approximately 0.4% and 0.7% respectively, of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterization of metabolites is not significant owing to the small amounts present in plasma and excreta.
Lotion: Minimal absorption would be anticipated with the lotion formulation.

Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Lotion: The lotion formulation may be applied to scalp lesions.

Cream: Adults (including elderly patients) and Children: Apply a thin film to the affected skin areas once daily until the lesion heals or for a duration of 3 weeks whichever is sooner.
Melomet cream may be used in pediatric patients 2 years of age or older.
Route of Administration: To be applied topically to the skin.
Lotion: Recommended Dosage: Apply a few drops of Melomet Lotion 0.1% w/w to affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears.
Route of Administration: Topical application.

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 cases of chronic toxicity, slow withdrawal of corticosteroids is advised.

Cream: Contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
Lotion: Melomet Lotion 0.1% w/w is contraindicated in skin atrophy, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum) parasitical and fungal (e.g. candida or dermatophyte) infections of the scalp. Melomet Lotion 0.1% w/w should not be used on wounds or on skin which is ulcerated. Melomet Lotion 0.1% w/w should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the excipients.

If irritation or sensitization develops with the use of Melomet cream and lotion 0.1% w/w, treatment should be withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin. Long-term continuous therapy should be avoided in all patients irrespective of age.
Cream: Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used.
Melomet cream is not for ophthalmic use.
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. 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.
Lotion: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycaemia, and glycosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of Melomet Lotion 0.1% w/w in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended.
If used in childhood, occlusion should not be used and courses should be limited to 5 days.
Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis patient, careful supervision is important.
As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long-term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.
Melomet Lotion 0.1% w/w contains propylene glycol which may cause skin irritation. Care must be taken to keep the preparation away from the eyes. Melomet topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) 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 of visual disturbances 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.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Use in pregnancy: There is inadequate evidence to support the safety use 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 may therefore be a very small risk of such effects in the human foetus. It should be used during pregnancy only if the potential benefit justifies potential risk to the mother or the fetus.
Cream: Drugs of this class should not be used on pregnant patients in large amounts or for prolonged periods of time.
Lotion: During pregnancy treatment with Melomet Lotion 0.1% w/w should be performed only on the physician's order. Then however, the application on large body surface areas over a prolonged period should be avoided.
However as with all topically applied glucocorticoids, the possibility that fetal growth may be affected by glucocorticoid passage through the placental barrier should be considered.
Use in lactation: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Cream: Caution should be exercised when Melomet cream is administered to a nursing mother.
Lotion: Melomet Lotion 0.1% w/w 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, breast-feeding should be discontinued.

Cream: Local adverse reactions reported very rarely include paresthesia, pruritus and signs of skin atrophy.
Local adverse reactions reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Lotion: Local adverse reactions rarely reported 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. Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.

Lotion: Not known.

Keep in an airtight container.
Store at temperature below 30°C.
Protect from light and moisture.
Shelf-Life: Cream: 3 years from the date of manufacture.

Topical Corticosteroids

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

C