General Recommendations: The therapeutic effect of Montelukast on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma.
Montelukast as an Alternative Treatment Option to Low-Dose Inhaled Corticosteroids for Mild Persistent Asthma: Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of Montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients 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. Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week and normal lung function between episodes. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti inflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically evaluated for their asthma control.
Montelukast 4 mg: Montelukast as Prophylaxis of Asthma for 2 to 5 Year Old Patients in Whom the Predominant Component is Exercise-Induced Bronchoconstriction: In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids. Patients should be evaluated after 2 to 4 weeks of treatment with Montelukast. If satisfactory response is not achieved, an additional or different therapy should be considered.
Therapy with Montelukast in Relation to Other Treatments for Asthma: When treatment with Montelukast is used as add-on therapy to inhaled corticosteroids, Montelukast should not be abruptly substituted for inhaled corticosteroids.
Montelukast 4 mg: This medicinal product is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, an adapted formulation should be used (e.g. granule formulation). The dosage for pediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken in the evening. If taken in connection with food, Montelukast should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary. Montelukast 4 mg chewable tablet formulation is not recommended below 2 years of age.
The dosage is the same for both male and female patients.
5 mg chewable tablets are available for pediatric patients 6 to 14 years of age.
Montelukast 5 mg: The dosage for pediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. lf taken in connection with food, Montelukast should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary.
The dosage is the same for both male and female patients.
Renal Impairment: No dosage adjustment is necessary for patients with renal insufficiency.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment.
Montelukast 10 mg: The dosage for adults 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.
General Recommendations: The therapeutic effect of Montelukast sodium (Montelukast) on parameters of asthma control occurs within one day. Montelukast sodium (Montelukast) may be taken with or without food. Patients should be advised to continue taking Montelukast sodium (Montelukast) even if their asthma is under control, as well as during periods of worsening asthma. Montelukast sodium (Montelukast) should not be used concomitantly with other products containing the same active ingredient, Montelukast.
No dosage adjustment is necessary for the elderly, or 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.
Therapy with Montelukast Sodium (Montelukast) in Relation to Other Treatments for Asthma: Montelukast sodium (Montelukast) can be added to a patient's existing treatment regimen.
Inhaled Corticosteroids: Treatment with Montelukast sodium (Montelukast) can be used as add-on therapy in patients when inhaled corticosteroids plus "as needed" short acting β-agonists provide inadequate clinical control. Montelukast sodium (Montelukast) should not be abruptly substituted for inhaled corticosteroids.
Tell your doctor about all other medicines you use, especially:
This list is not complete and other drugs may interact with Montelukast. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Montelukast 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 estradiol/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 CYP2C8. However, data from a clinical drug-drug interaction study involving Montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) demonstrated that Montelukast does not inhibit CYP2C8 in vivo. Therefore, Montelukast is not anticipated to alter the metabolism of drugs metabolized by this enzyme (e.g. paclitaxel, rosiglitazone, and repaglinide.)
In vitro studies have shown that Montelukast is a substrate of CYP 2C8, 2C9, and 3A4. Data from a clinical drug-drug interaction study involving Montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) demonstrated that gemfibrozil increased the systemic exposure of Montelukast by 4.4-fold.
Co-administration of itraconazole, a strong CYP 3A4 inhibitor, with gemfibrozil and Montelukast did not further increase the systemic exposure of Montelukast. The effect of gemfibrozil on systemic exposure of Montelukast is not considered to be clinically meaningful based on clinical safety data with doses greater than the 10 mg approved dose in adults (e.g., 200 mg/day to adult patients for 22 weeks, and up to 900 mg/day to patients for approximately one week) where clinically important adverse experiences were not observed. Therefore, no dosage adjustment of Montelukast is required upon co-administration with gemfibrozil. Based on in vitro data, clinically important drug interactions with other known inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. In addition, co-administration of Montelukast with itraconazole alone resulted in no significant increase in the systemic exposure of Montelukast.
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Information checked by Dr. Sachin Kumar, MD Pharmacology