Asthmatin/Asthmatin 4

Montelukast Na

Asthmatin Prophylaxis & chronic treatment of asthma, symptomatic relief of seasonal & perennial allergic rhinitis in adults & adolescents ≥15 yr. Asthmatin 4 Add-on therapy in childn 2-5 yr w/ mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids & in whom 'as-needed' short-acting β-agonists provide inadequate clinical control of asthma. Alternative treatment option to low-dose inhaled corticosteroids for childn 2-5 yr w/ mild persistent asthma w/o recent history of serious asthma attacks that required oral corticosteroid use, & who have demonstrated incapability of using inhaled corticosteroids. Prophylaxis of asthma in childn ≥2 yr in which the predominant component is exercise-induced bronchoconstriction.

Asthmatin Adult & adolescent ≥15 yr 1 tab daily in the evening. Asthmatin 4 Childn 2-5 yr 1 tab daily in the evening.

Tab:May be taken with or without food:Preferably taken in the evening. Chewtab:Should be taken on an empty stomach:Chew tab before swallowing.

Hypersensitivity.

Do not abruptly substitute for inhaled or oral corticosteroids. Reserve use in patients w/ allergic rhinitis for those who have inadequate response or intolerance to alternative therapies. Reports of neuropsychiatric events in adult, adolescent, & ped patients w/ & w/o previous history of psychiatric disorder. Asthmatin Not indicated for reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Do not use as monotherapy for treatment & management of exercise-induced bronchospasm. Avoid aspirin & NSAIDs in patients w/ known aspirin sensitivity. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Should be used during pregnancy only if clearly essential. Caution when given to a nursing mother. Asthmatin 4 Advise patients to never use oral montelukast to treat acute asthma attacks. Advise patients to continue taking montelukast even if asthma is under control, as well as during periods of worsening asthma. Not recommended as monotherapy in patients w/ moderate persistent asthma. Patients on therapy w/ anti-asthma agents, including montelukast, may present w/ systemic eosinophilia, sometimes presenting w/ clinical features of vasculitis consistent w/ Churg-Strauss syndrome. Contains aspartame. Caution in patients w/ phenylketonuria. No data on patients w/ severe hepatic impairment. May be used during pregnancy & in breast-feeding mothers only if considered to be clearly essential. Do not give to childn <2 yr.

Asthmatin Increased bleeding tendency; hypersensitivity reactions, including anaphylaxis, hepatic eosinophilic infiltration; agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thinking & behavior (including suicide), tic, & tremor; dizziness, drowsiness, paraesthesia/hypoesthesia, seizure; palpitations; diarrhoea, dry mouth, dyspepsia, nausea, vomiting; elevated ALT & AST, cholestatic hepatitis; angioedema, bruising, urticaria, pruritus, rash; arthralgia, myalgia including muscle cramps; asthenia/fatigue, malaise, oedema. Asthmatin 4 URTI. Diarrhoea, nausea, vomiting; elevated ALT & AST; rash; pyrexia.

Caution w/ inducers of CYP3A4, 2C8, & 2C9 eg, phenytoin, phenobarb, rifampicin. Decreased AUC w/ phenobarb. Increased systemic exposure w/ gemfibrozil (inhibitor of both CYP2C8 & 2C9).

Antiasthmatic & COPD Preparations

R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.

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