Singulair (Montelukast Sodium)

(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.

Health Professionals should:

• 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.

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Montelukast is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in adults and children 6 months of age and older. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.

Montelukast comes as a tablet, a chewable tablet, and granules to take by mouth. Montelukast is usually taken once a day with or without food. When montelukast is used to treat asthma, it should be taken in the evening. When montelukast is used to prevent breathing difficulties during exercise, it should be taken at least 2 hours before exercise. If you are taking montelukast once a day on a regular basis, or if you have taken a dose of montelukast within the past 24 hours, you should not take an additional dose before exercising. When montelukast is used to treat allergic rhinitis, it may be taken at any time of day. Take montelukast at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take montelukast exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you are giving the granules to your child, you should not open the foil pouch until your child is ready to take the medication. There are several ways that you can give the granules to your child, so choose the one that works best for you and your child. You may pour all of the granules directly from the packet into your child's mouth to be swallowed immediately. You may also pour the entire packet of granules onto a clean spoon and place the spoonful of medication in your child's mouth. If you prefer, you may mix the entire packet of granules in 1 teaspoon (5 mL) of cold or room temperature baby formula, breast milk, applesauce, soft carrots, ice cream, or rice. You should not mix the granules with any other foods or liquids, but your child may drink any liquid right after he or she takes the granules. If you mix the granules with one of the allowed foods or drinks, use the mixtures within 15 minutes. Do not store unused mixtures of food, formula, or breast milk and the medication. Do not use montelukast to treat a sudden attack of asthma symptoms. Your doctor will prescribe a short-acting inhaler to use during attacks. Talk to your doctor about how to treat symptoms of a sudden asthma attack. If your asthma symptoms get worse or if you have asthma attacks more often, be sure to call your doctor. If you are taking montelukast to treat asthma, continue to take or use all other medications that your doctor has prescribed to treat your asthma. Do not stop taking any of your medications or change the doses of any of your medications unless your doctor tells you that you should. If your asthma is made worse by aspirin, do not take aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) during your treatment with montelukast. Montelukast controls the symptoms of asthma and allergic rhinitis but does not cure these conditions. Continue to take montelukast even if you feel well. Do not stop taking montelukast without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of montelukast in a 24 hour period.

Montelukast may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• heartburn
• stomach pain
• tiredness
• diarrhea

Some side effects can be serious. If you experience any of the following symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• 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)

Montelukast may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.