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TEVA-MONTELUKAST is a brand name for Montelukast, supplied as a tablet (chewable). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................... 3 CONTRAINDICATIONS .............................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Serious neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking montelukast. Therefore, physicians should discuss the benefits and risks of TEVA-MONTELUKAST use with patients and caregivers when prescribing TEVA- MONTELUKAST.
TEVA-MONTELUKAST should be taken as prescribed and should not be used more often than recommended. The safety and efficacy of montelukast sodium was demonstrated in clinical trials where it was administered in the evening without regard to the time of food ingestion.
There have been no clinical trials evaluating the relative efficacy of morning versus evening dosing. However, no difference in pharmacokinetics was noted between morning and evening dosing. General Recommendations The therapeutic effect of montelukast sodium on parameters of asthma occurs within one day.
TEVA-MONTELUKAST tablets and chewable tablets, can be taken with or without food. Patients should be advised to continue taking TEVA-MONTELUKAST while their asthma is controlled, as well as during periods of worsening asthma. Therapy with TEVA-MONTELUKAST in Relation to Other Treatments for Asthma TEVA-MONTELUKAST can also be added to a patient’s existing treatment regimen.
Bronchodilator Treatments:
TEVA-MONTELUKAST 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 montelukast sodium 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. It remains to be determined whether the withdrawal from inhaled corticosteroids can be maintained for extended periods, or possibly indefinitely. TEVA- MONTELUKAST should not be abruptly substituted for inhaled corticosteroids.
Oral Corticosteroids:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Montelukast in Canada.
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Limited data suggest that montelukast sodium may provide additional clinical benefit in patients currently treated with oral corticosteroids. Recommended Dose and Dosage Adjustment Adults 15 Years of Age and Older with Asthma and/or Seasonal Allergic Rhinitis The dosage for adults 15 years of age and older is one 10 mg tablet daily to be taken in the evening.
14 Pediatric Patients 6 to 14 Years of Age with Asthma The dosage for pediatric patients 6 to 14 years of age is one 5 mg chewable tablet daily to be taken in the evening. No dosage adjustment within this age group is necessary. Pediatric Patients 2 to 5 Years of Age with Asthma The dosage for pediatric patients 2 to 5 years of age is one 4 mg chewable tablet daily to be taken in the evening.
No dosage adjustment within this age group is necessary. Special Population No dosage adjustment is necessary for the elderly, for patients with renal insufficiency, or mild to moderate hepatic impairment, or for patients of either gender.
Missed Dose TEVA-MONTELUKAST should be taken as prescribed. If a dose is missed, the patient should be instructed to take the next dose when it is due. The patient should be instructed not to take 2 doses at the same time. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre.
No specific information is available on the treatment of overdosage with montelukast. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
There have been reports of acute overdosage in post-marketing experience and clinical studies with montelukast sodium. These include reports in adults and children with a dose as high as 1000 mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients.
There were no adverse experiences in the majority of overdosage reports. The adverse experiences were consistent with the safety profile of montelukast sodium and most frequently included abdominal pain, somnolence, thirst, headache, vomiting, psychomotor hyperactivity, and less frequently convulsion.
It is not known whether montelukast is dialyzable by peritoneal dialysis or hemodialysis. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action The cysteinyl leukotrienes (LTC4, LTD4, LTE4), are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils.
These important pro- asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 15 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells).
CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include a number of airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.
In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction.
Montelukast sodium has not been assessed in intranasal challenge studies. The clinical relevance of intranasal challenge studies is unknown. Montelukast is an orally active compound that improves parameters of asthmatic inflammation.
Based on biochemical and pharmacological bioassays, it binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway […]