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Floaid (Montelukast Sodium) 10mg Tablets 5mg Chewable Tablets 4mg Paediatric Dry Powder Sachet COMPOSITION Floaid 10 mg tablets: Each film coated tablet contains 10.4 mg Montelukast Sodium U.S.P. equivalent to 10 mg Montelukast Acid. Floaid 5 mg chewable tablets: Each chewable tablet contains 5.2 mg Montelukast Sodium U.S.P. equivalent to 5 mg Montelukast Acid. Floaid 4 mg Paediatric Dry Powder sachet for Oral use: Each sachet of Floaid contains 4.15 mg Montelukast Sodium U.S.P. equivalent to 4 mg Montelukast Acid. DESCRIPTION a) Mode of Action: Montelukast Sodium is a selective leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT1 receptor. Therapeutic Indications 1. Asthma: Floaid 4 mg dry powder / Floaid 5 mg chewable tablet is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β-agonists provide inadequate clinical control of asthma. Floaid 4 mg dry powder may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids. Floaid 4 mg dry powder is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction. 1.1. Floaid 5 mg chewable tablet may also be an alternative treatment option to lowdose inhaled corticosteroids for 6 to 14 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids. Floaid 5 mg chewable tablet is also indicated in the prophylaxis of asthma in those 6 to 14 years old which the predominant component is exercise-induced choconstriction. 1.2. Floaid 10 mg tablet is indicated in the treatment of asthma as add-on therapy in patients 15 years and older with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as needed” short-acting β-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Floaid 10 mg tablet is indicated in asthma, Floaid 10 mg tablet can also provide symptomatic relief of seasonal allergic rhinitis. Floaid 10 mg tablet is also indicated in the prophylaxis of asthma in which the predominant component is exercise induced bronchoconstriction in patients 15 years and older 2. Perennial Allergic Rhinitis (PAR):in patients 6 months of age and older 3. Acute prevention of exercise-induced bronchoconstriction (EIB): in patients 6 years of age and older. 4. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older DOSAGE AND ADMINISTRATION Floaid 4 mg Dry Powder: Floaid 5 mg chewable tablet: The dosage for paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. The tablets are to be chewed before swallowing. If taken in connection with food, Floaid 5 mg chewable tablet should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary. General recommendations: The therapeutic effect of Floaid 5 mg chewable tablet on parameters of asthma control occurs within one day. Patients should be advised to continue taking Floaid 5 mg chewable tablet even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. Floaid 5 mg chewable tablet as an alternative treatment option to low-dose inhaled corticosteroids for mild persistent asthma. Therapy with Floaid 5 mg chewable tablet in relation to other treatments for asthma: When treatment with Floaid 5 mg chewable tablet is used as add-on therapy to inhaled corticosteroids, Floaid 5 mg chewable tablet should not be abruptly substituted for inhaled corticosteroids. Floaid 10 mg tablet: Floaid 10 mg film-coated tablets are available for adults and adolescents 15 years of age and older. The dosage for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis is one 10 mg tablet daily to be taken in the evening