Montelukast paediatrics

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What if I give too much? In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8.

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With prolonged treatment, the safety profile did not change in these patients either. Patients should be evaluated after 2 to 4 weeks of treatment with montelukast. 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 see section 4.

Any unused product or waste material should be disposed of in accordance with local requirements 7. The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients. The dose will be shown on the medicine label. There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.

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Less than 12 months: Studies in patients with renal impairment have not been undertaken. Skin and subcutaneous tissue disorders.

After administration of the 4 mg chewable tablet to paediatric patients years of age in the fasted state, C max is achieved 2 hours after administration. If satisfactory control of asthma is not achieved at follow-up usually within one monththe 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. Print this page Add to My Med List. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children. In a clinical drug-drug interaction study involving montelukast and gemfibrozil an inhibitor of both CYP 2C8 and 2C9 gemfibrozil increased the systemic exposure of montelukast by 4.

Usual Adult Dose for Asthma - Maintenance

The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.

If you think someone else may have taken the medicine by accident, contact your doctor for advice. The signs of toxicity in animals were increased excretion of saliva, gastro-intestinal symptoms, loose stools and ion imbalance. Montelukast paediatric 5 mg chewable tablets.

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It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. Limited data from available pregnancy databases do not suggest a causal relationship between Montelukast and malformations i. No abnormalities were seen in rats.

Montelukast which is a leukotriene receptor type I inhibitor has variable efficacy in children with AR and the guidelines recommend its use in children with seasonal AR aged six years and above. There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly. In a placebo-controlled study in paediatric patients 6 months to 5 years of age who had intermittent asthma but did not have persistent asthma, treatment with montelukast was administered over a month period, either as a once-daily 4 mg regimen or as a series of day courses that each were started when an episode of intermittent symptoms began.