A leukotriene modifier - It is used to prevent and treat the symptoms of asthma
FDA Alerts
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.
MONTELUKAST (mon te LOO kast) is used to prevent and treat the symptoms of asthma. It is also used to treat allergies. Do not use for an acute asthma attack.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine should be given by mouth. Follow the directions on the prescription label. Take this medicine at the same time every day. You may take this medicine with or without meals. Do not chew the tablets. Do not stop taking your medicine unless your doctor tells you to.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 15 years of age for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your allergy or asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.
If you have asthma, talk to your doctor about what to do in an acute asthma attack. Always have your inhaled rescue medicine for asthma attacks with you.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash or hives, or swelling of the face, lips, or tongue
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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