Montelukast

What it is used for

Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 2 years of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older.

Reserve use for patients who have an inadequate response or intolerance to alternative therapies. 1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

1.3 Allergic Rhinitis sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, use for patients who have an inadequate response or intolerance to alternative therapies.

Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.

The most important thing to know

Serious mental health problems have happened in people taking montelukast sodium or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking montelukast sodium tablets and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms: agitation, including aggressive behavior or hostility attention problems bad or vivid dreams depression disorientation (confusion) feeling anxious irritability hallucinations (seeing or hearing things that are not really there) memory problems obsessive-compulsive symptoms restlessness sleep walking stuttering suicidal thoughts and actions (including suicide) tremor trouble sleeping uncontrolled muscle movements What are Montelukast sodium tablets?

Montelukast sodium tablets are a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium tablets do not contain a steroid. Montelukast sodium tablets are used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 15 years and older.

How to take it

For anyone who takes Montelukast sodium tablets: Take Montelukast sodium tablets exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium tablet to take, and when to take it. Stop taking montelukast sodium tablets and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking You can take montelukast sodium tablet with food or without food.

If you or your child misses a dose of montelukast sodium tablets, just take the next dose at your regular time. Do not take 2 doses at the same time. If you take too much montelukast sodium, call your healthcare provider right away. For adults and children 15 years of age and older with asthma: Take montelukast sodium tablet 1 time each day, in the evening.

Continue to take montelukast sodium tablet every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms. Tell your healthcare provider right away if your asthma symptoms get worse, or if you need to use your rescue inhaler medicine more often for asthma attacks. Always have your rescue inhaler medicine with you for asthma attacks.

Continue to take your other asthma medicines as prescribed unless your healthcare provider tells you to change how you take these medicines. For people 15 years of age and older for the prevention of exercise-induced asthma: Take montelukast sodium tablet at least 2 hours before exercise. Always have your rescue inhaler medicine with you for asthma attacks.

If you take montelukast sodium tablet every day for chronic asthma or allergic rhinitis, do not take another dose to prevent exercise-induced asthma. Talk to your healthcare provider about your treatment for exercise-induced asthma. Do not take 2 doses of montelukast sodiun tablet within 24 hours (1 day). For anyone 15 years of age and older with seasonal allergic rhinitis, or for anyone 15 years of age and older with perennial allergic rhinitis: Take montelukast sodium tablet 1 time each day, at about the same time each day.

Side effects, and when to stop

Montelukast sodium may cause serious side effects including. Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast sodium. This sometimes happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.

Tell your healthcare provider right away if you get one or more of these symptoms: a feeling of pins and needles or numbness of arms or legs a flu-like illness rash severe inflammation (pain and swelling) of the sinuses (sinusitis) The most common side effects of montelukast sodium include: upper respiratory infection fever headache sore throat cough stomach pain diarrhea earache or ear infection flu runny nose sinus infection These are not all the possible side effects of montelukast tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take montelukast sodium if you need relief right away for a sudden asthma attack. If you have an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks. 2. Prevent exercise-induced asthma in people 15 years of age and older. 3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose and itching of the nose.

Montelukast sodium is used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines: outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 15 years and older, and indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 15 years and older.

Do not take montelukast sodium tablets if you are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium tablets. Before taking Montelukast sodium tablets, tell your healthcare provider about all your medical conditions, including if you: are allergic to aspirin have or have had mental health problems.

are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant, as montelukast sodium may not be right for you. are breastfeeding or plan to breastfeed. It is not known if montelukast sodium passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium works, or montelukast sodium may affect how your other medicines work.

What to avoid

If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast sodium tablets?.

Storing it

Store montelukast sodium tablets at 68°-77°F (20° to 25°C). Keep montelukast sodium tablets in the package it comes in. Keep montelukast sodium tablets in a dry place and keep it away from light. Keep montelukast sodium tablets and all medicines out of reach of children.