BEASY Tablet

In children (4m sachet/5mg tablet) and adult (10mg tablet) patients for the prophylaxis and chronic treatment of asthma, including the prevention of day-and night time symptoms, the prevention of exercise-induced bronchoconstriction, and in the treatment of aspirin sensitive asthmatic patients.

Beasy is indicated in adults and children 2 years of age for the relief of day and night time symptoms of seasonal allergic rhinitis.

Beasy is also indicated in adults and children 6 months of age for the relief of day and night time symptoms of perennial allergic rhinitis.

Dosage and Administration

Adults & Adolescents 15 years and above: 1 tablet to be taken at night.

Beasy may be taken with or without food. The therapeutic effect of Beasy asthma control parameters occurs within 1 day of start of therapy. Patients should be advised to continue usage while the asthma is under control, as well as during periods or worsening asthma.

Dosage adjustment is not necessary in elderly patients, patients with renal insufficiency, or patients with mild-to-moderate hepatic impairment.

Beasy can be added to a patient’s existing treatment regimen for asthma.

Reduction in Concomitant Therapy of Asthma

Bronchodilator Treatments: Beasy can be added to the existing treatment regimen of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the first dose), the patient’s bronchodilator therapy can be reduced as tolerated.

Inhaled Corticosteroids: Treatment with Beasy provides additional clinical benefit to patients treated with inhaled corticosteroids. A reduction in the corticosteroid dose can be made as tolerated. The dose should be reduced gradually. In some patients, the dose of inhaled corticosteroids can be tapered off completely. Beasy should not be abruptly substituted for inhaled corticosteroids.

Hypersensitivity to montelukast or any other component of Beasy.

Side effects usually are mild, generally do not require discontinuation of therapy. The overall incidence of side effects reported with montelukast is comparable to placebo.

Some of the common side effects include, asthenia, dyspepsia, dizziness, headache, nasal congestion, cough, and flu like symptoms. In children observed also side effects include, diarrhea, laryngitis, pharyngitis, nausea etc.

Beasy may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

Montelukast has been studied in pregnant women. Beasy should be used during pregnancy only if clearly needed.

It is not known if montelukast is excreted in human milk. Because may drugs are excreted in human milk, caution should be exercised when Beasy is given to lactating mother.

The efficacy of oral Beasy for the treatment of acute asthma attacks has not been established. Therefore, oral tablets of Beasy should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.

While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Beasy should not be abruptly substituted for inhaled or oral corticosteroids.