Opikast 4 mg

DOSAGE AND ADMINISTRATION

OPIKAST should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs Patients with both asthma and allergic rhinitis should take only one tablet daily in the evening. Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal Allergic Rhinitis The dosage for pediatric patients 2 to 5 years of age is one 4-mg chewable tablet daily. Pediatric Patients 6 Months to 2 Years of Age with Asthma: The dosage for pediatric patients 6 months to 2 years of age is one 4-mg chewable tablet daily. General Recommendations: The therapeutic effect of OPIKAST on parameters of asthma control occurs within one day. OPIKAST chewable tablets can be taken with or without food Patients should be advised to continue taking OPIKAST while their asthma is controlled, as well as during periods of worsening asthma. No dosage adjustment is necessary for pediatric patients, for the elderly, for patients with renal insufficiency, or mild-to-moderate hepatic impairment. or for patients of either gender Therapy with OPIKAST in Relation to other Treatments for Asthma OPIKAST can be added to a patient's existing treatment regimen. Reduction in Concomitant Therapy: Bronchodilator Treatments: OPIKAST can be added to the 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 OPIKAST 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 with medical supervision. In some patients, the dose of Inhaled corticosteroids can be tapered off completely, OPIKAST should not be abruptly substituted for inhaled corticosteroids.

PREGNANCY

Montelukast sodium has not been studied in pregnant women. OPIKAST should be used during pregnancy only if clearly needed.

NURSING MOTHERS

It is not known if OPIKAST is excreted in human milk . Because many drugs are excreted in human milk, caution should be exercised when OPIKAST is given to a nursing mother.

PEDIATRIC USE

montelukast has been studied in pediatric patients 6 months to 14 years of age (see Dosage and Administration). Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. Studies have shown that montelukast does not affect the growth rate of pediatric patients.

USE IN THE ELDERLY

In clinical studies. there were no age-related differences in the efficacy or safety profiles of montelukast sodium.

DRUG INTERACTIONS

OPIKAST may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. and in the treatment of allergic rhinitis. 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. prednisolone, oral contraceptives (ethinyl estradior/norethindrone 35/1), terfenadine, digoxin and warfarin.   The area under the plasma concentration-time curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. No dosage adjustment for montelukast is recommended. In vitro studies have shown that montelukast is an inhibitor of CYP 2C8. Montelukast may inhibit the metabolism of drugs primarily metabolized by CYP 2CB. (E.g., paclitaxel. rosiglitazone. repaglinide);however. no in vivo interaction studies have been performed.

HOW SUPPLIED:

Carton box containing 1, 2, 3 Al -Al blisters. Each contains 7 tablets + pamphlet

STORAGE

Store at a temp. not exceeding 30 ºC in dry place. Keep out of the reach of children