It allows continued monitoring of the benefit/risk balance of the medicinal product.

Asthma and allergy drug montelukast -- sold as a generic and under the brand name Singulair -- will get a "boxed warning" over potential ties to neuropsychiatric effects, the … In those asthmatic patients in whom Singulair is indicated in asthma, Singulair can also provide symptomatic relief of seasonal allergic rhinitis.Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.The recommended dose for adults and adolescents 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.The therapeutic effect of Singulair on parameters of asthma control occurs within one day.

All rights reserved.To bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in. It will help control your asthma.If you have any further questions on the use of this medicine, ask your doctor or pharmacist.Like all medicines, this medicine can cause side effects, although not everybody gets them.In clinical studies with Singulair 10 mg film-coated tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to Singulair were:These were usually mild and occurred at a greater frequency in patients treated with Singulair than placebo (a pill containing no medication).Uncommon: the following may affect up to 1 in 100 peopleRare: the following may affect up to 1 in 1,000 peopleVery rare: the following may affect up to 1 in 10,000 peopleOther side effects while the medicine has been on the marketVery common: the following may affect more than 1 in 10 peopleCommon: the following may affect up to 1 in 10 peopleUncommon: the following may affect up to 1 in 100 peopleRare: the following may affect up to 1 in 1,000 peopleVery rare: the following may affect up to 1 in 10,000 peopleIf you get any side effects, talk to your doctor, pharmacist or nurse.

For allergic rhinitis, also known as hay fever, we have determined that montelukast should be reserved for those who are not treated effectively with or cannot tolerate other allergy medicines. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Your doctor has prescribed Singulair to treat asthma, preventing your asthma symptoms during the day and night. In addition, it is approved to help control the nasal symptoms of seasonal outdoor allergies in patients 2 years and older and year-round indoor allergies in those 6 months and older. Some neuropsychiatric events may have been handled by discontinuation of the drug without a health care encounter.

Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.Singulair may be used during pregnancy only if it is considered to be clearly essential.Studies in rats have shown that montelukast is excreted in milk (see section 5.3). In this study, montelukast 10 mg tablets administered once daily demonstrated a statistically significant improvement in the Daily Rhinitis Symptoms score, compared with placebo.

Check with your doctor or pharmacist if you are not sure.For adults and adolescents 15 years of age and older:The recommended dose is one 10 mg tablet to be taken daily in the evening.If you are taking Singulair, be sure that you do not take any other products that contain the same active ingredient, montelukast.There were no side effects reported in the majority of overdose reports. Of the remaining 34 cases that were better documented, many contained additional risk factors that may have contributed to the suicide such as the use of medications or presence of comorbidities associated with increased risk for self-harm or behavioral disturbances. "The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks.

Montelukast works to help improve symptoms of asthma and allergic rhinitis by blocking substances in the body that may cause them. Continue typing to refine. The evaluation of asthma efficacy was not a primary objective in this study.In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function (FEVSignificant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEVIn aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEVMontelukast is rapidly absorbed following oral administration. You should consult your doctor before taking Singulair if you are breast-feeding or intend to breast-feed.Singulair is not expected to affect your ability to drive a car or operate machinery. Singulair works a bit differently than drugs such as antihistamines.