Product Data
Indications And Usage:
Asthma
Clear air® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Exercise-Induced Bronchoconstriction Clear air® is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Allergic Rhinitis Clear air® is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
Clear air® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Exercise-Induced Bronchoconstriction Clear air® is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Allergic Rhinitis Clear air® is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
Contraindications:
Hypersensitivity to any component of this product.
Dosage & Administration:
Asthma
Clear air® should be taken once daily in the evening. The following doses are recommended: For adults and adolescents15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet. For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion. Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older For prevention of EIB, a single 10 mg dose of Clear air® should be taken at least 2 hours before exercise. An additional dose of Clear air® should not be taken within 24 hours of a previous dose. Patients already taking Clear air® for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting ß-agonist. Safety and effectiveness in patients younger than 15 years of age have not been established. Daily administration of Clear air® for the chronic treatment of asthma has not been established to prevent acute episodes of EI B. Allergic Rhinitis For allergic rhinitis, Clear air® should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning . or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet . For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules. Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet. For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet. Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. Asthma and Allergic Rhinitis Patients with both asthma and allergic rhinitis should take only one Clear air® dose daily in the evening.
Clear air® should be taken once daily in the evening. The following doses are recommended: For adults and adolescents15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet. For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion. Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older For prevention of EIB, a single 10 mg dose of Clear air® should be taken at least 2 hours before exercise. An additional dose of Clear air® should not be taken within 24 hours of a previous dose. Patients already taking Clear air® for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting ß-agonist. Safety and effectiveness in patients younger than 15 years of age have not been established. Daily administration of Clear air® for the chronic treatment of asthma has not been established to prevent acute episodes of EI B. Allergic Rhinitis For allergic rhinitis, Clear air® should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning . or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet . For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules. Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet. For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet. Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. Asthma and Allergic Rhinitis Patients with both asthma and allergic rhinitis should take only one Clear air® dose daily in the evening.
Storage:
Store at temperature not exceeding 30˚C & In dry place Keep out of reach of children Packs: Clear air® 10 mg tablets are available in strips of 7 tablets in packs of 1 or 2 strips. Clear air® 5 mg chewable tablets are available in strips of 7 tablets in packs of 1 or 2 strips. Clear air® 4 mg chewable tablets are available in strips of 7 tablets in packs of 1 or 2 strips.
Pharmacological Properties:
Clear air® (montelukast soduim) is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotrience CysLT1 receptor. Pharmacokinetics Peak plasma concentrations of montelukast are achieved in 2 to 4 hours after oral doses. The mean oral bioavailability is 64% . montelukast is more than 99 % bound to plasma proteins. It is extensively metabolisd in the liver by cytochrome P450 isoenzymes CYP3A4, CYP2A9 , and is excreted principally in the faeces via the bile . Metabolism was reduced and the elimination half-life prolonged in patients with mild to moderate hepatic impairment.
