Each gram contains mometasone furoate 1 mg.
Excipients/Inactive Ingredients: Cetomacrogol emulsifying wax, White Vaseline, Isopropyl myristate, Cetostearyl alcohol, White beeswax, Colloidal silicon dioxide, Tween 80, Methylparaben, Propylparaben, ortho-Phosphoric acid, Sodium dihydrogen phosphate dihydrate, Disodium EDTA, Glycerin, Propylene glycol, N-methylpyrrolidone and Purified water.
Pharmacology: Pharmacodynamics: Mechanism of Action: Topical mometasone furoate is adrenocorticosteroid derivative incorporated into a vehicle suitable for application to skin or external mucous membranes. The primary therapeutic effects of the topical mometasone furoate is due to its anti-inflammatory activity which is nonspecific.
Topical mometasone furoate can diffuse across cell membranes to interact with cytoplasmic receptors located in both the dermal and intradermal cells.
At the cellular level, mometasone furoate appears to induce phospholipase A2 inhibitory proteins (lipocortins), thus depressing formation, release and activity of the endogenous mediators of inflammation such as prostaglandins, kinins, histamine, liposomal enzymes and the complement system.
When mometasone furoate is applied to inflamed skin, it inhibits the migration of macrophages and leukocytes into the area by reversing vascular dilation and permeability. The clinical result is a decrease in edema, erythema and pruritus.
By suppressing DNA synthesis, topical mometasone furoate has an antimitotic effect on epidermal cells. This property is useful in proliferative disorders such as psoriasis, but also can be demonstrated in normal skin.
Dose/concentration/time-pharmacodynamic response relationship: Data is not available.
Mechanism of toxicity: Data is not available.
Pharmacokinetics: Absorption: Percutaneous penetration of mometasone furoate varies among individuals and can be altered by using different vehicles; percutaneous penetration can be increased by the use of occlusive dressings and by inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).
Following topical application of mometasone furoate to normal skin, only small amounts of the drug appear to reach the dermis and subsequently the systemic circulation with the usual dosage. However, systemic absorption may be increased when the skin is inflamed or diseased.
Metabolism: Following percutaneous penetration of mometasone furoate, drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids. However, systemic metabolism of mometasone furoate has not been fully characterized or quantified; in animals, drug that is absorbed following topical application does not appear to accumulate in tissues.
Elimination: Systemically absorbed mometasone furoate and its metabolites may be excreted in urine and, to some extent, in bile.
For the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, in patients 2 years of age or older.
For patients 2 years of age or older: Apply a thin film of Mometasone GPO (0.1%) to the affected areas once daily. Do not use in pediatric patients for longer than 3 weeks.
Mode of Administration: Apply sparingly in thin films and rub into the affected area, usually once daily. It is recommended that Mometasone GPO (0.1%) not be used with occlusive dressings unless directed by physicians.
Acute ingestion is rarely a clinical problem. Acute adrenal insufficiency rarely reported after overdose.
Mometasone GPO (0.1%) is contraindicated in patients who are hypersensitive to mometasone furoate, or any components of this formulation; monotherapy in primary bacterial infections such as impetigo, paronychia, erysipelas, cellulitis, angular cheilitis, erythrasma; treatment of rosacea, perioral dermatitis or acne; ophthalamic use (prolonged ocular exposure may cause steroid-induced glaucoma and cataracts).
Topical application of mometasone furoate cream in healthy individuals revealed little or no evidence of local irritation in most patients, and the potential for contact irritation from the preparation and its vehicles was minimal and comparable to that of other commonly used topical corticosteroid formulations. In addition, there was no evidence of contact sensitization.
If local irritation develops, discontinue use and institute appropriate therapy.
In the presence of dermatological infection, institute appropriate therapy with an antifungal or antibacterial agent. If a favorable response does not occur promptly, Mometasone GPO (0.1%) should be discontinued until the infection is adequately controlled. Treating skin infections with mometasone furoate can extensively worsen the infection.
Systemic absorption mometasone furoate has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glycosuria. If HPA axis suppression is noted, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid.
Pediatric patients may be more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing's syndrome than mature individuals because of a greater skin surface area-to-body weight ratio.
Mometasone GPO (0.1%) is for topical use only; not for oral, ophthalmic or intravaginal use. Avoid use on the face, groin, or axillae.
Effects on ability to drive and use machine: Data is not available.
Pregnancy: US Pregnancy Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in pregnant women or studies in pregnant women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Labor and delivery: Data is not available.
Nursing mothers: Infant risk cannot be ruled out.
Acneiform eruptions; allergic contact dermatitis; burning; dryness; erythema; folliculitis; hypertrichosis; hypopigmentations; itching; irritation; numbness of fingers; perioral dermatitis; pruritus; stinging and cracking/tightenting of skin. The following may occur more frequently with occlusive dressings: maceration of the skin; miliaria; secondary infection; skin atrophy; striae; telangiectasia.
Also, there have been reports of development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroids.
Sensitivity to a particular dressing material or adhesive may occur occasionally.
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glycosuria. This is more likely to occur with occlusive dressings and with the more potent steroids. Patients with liver failure or children may be at higher risk. Lightheadedness and hives have been reported rarely.
Following prolonged application around the eyes, cataracts and glaucoma may develop. In diffusely atrophied skin, blood vessels may become visible on the skin surface; telangiectasia and purpura may occur at the site of trauma.
Do not store above 30°C. Store in the original container.
D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Cream (tube) 0.1% (white to off white, homogenous cream with odorless) x 5 g, 15 g.