Special Alerts:
[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of montelukast (Singulair) and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Montelukast is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking montelukast before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking montelukast for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair and http://www.fda.gov/cder/drug/early_comm/montelukast.htm.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Montelukast is usually taken once daily in the evening for prevention of asthma or allergy symptoms. For exercise-induced bronchoconstriction, take a single dose at least 2 hours before you exercise, and do not take another dose for at least 24 hours. Follow your doctor's instructions.
Swallow the
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After opening or mixing the oral granules, you must use them within 15 minutes. Do not save an open packet or mixed medicine for later use.
Do not use montelukast to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks. It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after several weeks of treatment.Asthma is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor, even if you have no asthma symptoms.
If you also take a steroid asthma medicine, do not stop using it suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.
Store montelukast at room temperature away from moisture and heat. Do not open a packet of oral granules until you are ready to use the medicine.Take the missed dose as soon as you remember. If it is almost time for your next dose,
skip the missed dose and take the medicine at your next regularly scheduled time.
Symptoms of a montelukast overdose are not known.
Avoid situations or activities that may trigger an asthma attack.
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