Properties
What is it?
International Nonproprietary Name - Mometasonum Pharmacological group: Antimicrobial preparations containing glucocorticosteroids International Nonproprietary Name Mometasone Furoate Nasal Spray BP Composition Each actuation delivers Mometasone Furoate Monohydrate equivalent to 50 mcg Mometasone Furoate BP. Active ingredients Mometasone Furoate Monohydrate Equivalent to Mometasone Furoate BP------- 0.05% w/w Preservatives Benzalkonium Chloride Solution BP - 0.02% w/w Phenylethyl Alcohol USP 0.25% w/w Excipients - q.s. Mechanism of action Mometasone furoate is a topical corticosteroid with topical anti-inflammatory properties at doses that are not systemically active. Presumably, a large part of the mechanism of the antiallergic and anti-inflammatory effects of mometasone furoate is its ability to suppress the release of mediators of allergic reactions. Mometasone furoate significantly inhibits the release of leukotrienes from leukocytes of allergic patients. In cell culture, mometasone furoate has shown a high ability to reduce the synthesis and release of IL-1, IL-5, IL-6, TNFα. It is to some extent a potential inhibitor of leukotriene production. Mometasone is also a potent inhibitor of Th2 cytokine, IL-2 and IL-5 production from human CD4+ T cells. Indications Mometasone Furoate 50 mcg/actuation Nasal Spray, Suspension is indicated for use in adults and children from 3 years of age for the treatment of seasonal allergic and perennial rhinitis. Mometasone Furoate 50 mcg/actuation Nasal Spray, Suspension is indicated for the treatment of nasal polyps in adults aged 18 years or older. Dosage and administration After initial priming of the Mometasone Furoate spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing 50 micrograms of mometasone furoate monohydrate equivalent to mometasone furoate. Method of administration Seasonal allergic or perennial rhinitis Adults (including elderly patients) and children aged 12 years and older: The usual recommended dose is 2 actuations (50 mcg/actuation) in each nostril once daily. (Total dose 200 mcg). After symptom control, the dose may be reduced to one actuation in each nostril (total dose 100 mcg) which may be an effective maintenance dose. If adequate symptom control is not achieved, the maximum daily dose may be increased to 4 actuations in each nostril, once daily (total dose 400 mcg). Dose reduction is recommended after symptom control. Children aged 3 to 11 years: The usual recommended dose is one actuation (50 mcg/actuation) in each nostril once daily (total dose 100 mcg). Mometasone Furoate Nasal Spray has shown a clinically significant onset of action within 12 hours of the first dose in some patients with seasonal allergic rhinitis. However, the full effect of treatment may be achieved within the first 48 hours. However, the patient should continue regular use to achieve full therapeutic effect. Treatment with Mometasone Furoate Nasal Spray may be initiated a few days before the anticipated start of the pollen season in patients with a history of mild to moderate symptoms of seasonal allergic rhinitis. Nasal polyposis The usual recommended starting dose for polyposis is 2 actuations (50 mcg/actuation) in each nostril once daily (total dose 200 mcg). If symptoms are not adequately controlled after 5-6 weeks, the dose may be increased to two sprays daily dose in each nostril twice daily (total dose is 400 mcg). Dose titration should be performed to the lowest dose at which effective symptom control is maintained. If no improvement is observed after 5-6 weeks of twice daily administration, the patient needs to be re-examined and the treatment strategy revised.