Singulair (Montelukast Sodium)
Prescription required. May be split. Product of Turkey. Shipped from Mauritius.
Generic equivalents for Singulair... What are generics?
Prescription required. May be split. Product of UK/EU. Shipped from United Kingdom.
To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. read more
Montelukast Sodium Information
(mon te loo' kast)[Posted 03/04/2020] AUDIENCE:Patient, Health Professional, Pharmacy, Allergy and Immunology ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. FDA is taking this action after a review of available information that led us to reevaluate the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate. BACKGROUND: Montelukast is FDA-approved for asthma and allergies. It is a prescription medicine approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children 1 year and older. It is approved to prevent exercise-induced asthma in patients 6 years and older. Montelukast is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older. RECOMMENDATION: Patients should talk with your health care professional about:
- the benefits and risks of montelukast, as many other safe and effective allergy medicines are widely available.
- any history of mental illness before starting treatment.
- Ask patients about any history of psychiatric illness prior to initiating treatment.
- Consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine.
- Advise all patients of the risk of neuropsychiatric events when prescribing montelukast. Warnings about these side effects are included in the existing prescribing information; however, many health care professionals and patients/caregivers are not aware of this risk, and suicides and other adverse events continue to be reported.
- Advise patients and parents/caregivers that the patient should stop taking montelukast and contact a health care professional immediately if changes in behavior or new neuropsychiatric symptoms, suicidal thoughts or behavior occur.
- Monitor all patients treated with montelukast for neuropsychiatric symptoms. Events have occurred in patients with and without pre-existing psychiatric disease.
- Encourage patients and parents/caregivers to read the Medication Guide they receive with their montelukast prescriptions, which explains the safety risks and provides other important information.
Before taking montelukast,
- tell your doctor and pharmacist if you are allergic to montelukast or any other medications, or any of the ingredients in montelukast tablet, chewable tablet, or granules.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention gemfibrozil (Lopid), phenobarbital and rifampin (Rifadin, Rimactane, in Rifamate, Rifater). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
- tell your doctor if you have or have ever had liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking montelukast, call your doctor.
- you should know that your mental health may change in unexpected ways while you are taking montelukast. You should call your doctor right away if you experience any of the following symptoms: agitation, aggressive behavior, anxiety, irritability, difficulty paying attention, trouble with memory, confusion, unusual dreams, hallucinations (seeing things or hearing voices that do not exist), repeating thoughts that you cannot control, depression, difficulty falling asleep or staying sleep, restlessness, sleep walking, suicidal thoughts or actions (thinking about harming or killing yourself or planning or trying to do so), or tremor (uncontrollable shaking of a part of the body). Your doctor will decide if you should continue taking montelukast.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the chewable tablets contain aspartame that forms phenylalanine.
- stomach pain
- difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, or eyes; hoarseness; itching; rash; hives
- blistering, peeling, or shedding skin
- flu-like symptoms, rash, pins and needles or numbness in the arms or legs, pain and swelling of the sinuses
- ear pain, fever (in children)