Montelukast Sodium, Oral

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KEY POINTS

• This medicine is taken by mouth to help prevent and control asthma attacks, including attacks caused by exercise. It may also be prescribed to treat seasonal allergy symptoms (hay fever) or year-round allergy symptoms. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: leukotriene receptor antagonist

Generic and brand names: montelukast sodium, oral; Singulair

What is this medicine used for?

This medicine is taken by mouth to help prevent and control asthma attacks, including attacks caused by exercise. It may also be prescribed to treat seasonal allergy symptoms (hay fever) or year-round allergy symptoms.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease
• Phenylketonuria (PKU). The chewable tablet contains phenylalanine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Take this medicine regularly, even if you feel well.

Check with your healthcare provider before using this medicine to prevent or treat asthma in children under age 12 months.

Check with your healthcare provider before using this medicine to prevent exercise-induced asthma in children under age 6 years.

Check with your healthcare provider before using this medicine to treat seasonal allergy symptoms in children under age 2 years and year-round allergies in children under 6 months.

You may take this medicine with or without food.

This medicine comes in different forms. If you have the regular tablets, swallow them whole. Do not break, crush, or chew them. The chewable tablet must be chewed before you swallow it.

The granules may be swallowed alone or mixed with a spoonful of applesauce, carrots, rice, ice cream baby formula or breast milk. Do not add to any other liquid. Do not open the packet until ready to use. The medicine must be used within 15 minutes of opening. Throw away any unused portion.

If you are taking this medicine to prevent asthma or allergy symptoms, take it once each day, in the evening.

If you are taking this medicine to prevent exercise-induced asthma, take it at least 2 hours before exercise and do not take it again for at least 24 hours.

Do NOT take 2 doses of this medicine within 24 hours.

This medicine is not intended to treat an asthma attack in progress. Your healthcare provider will prescribe a medicine that you inhale through your mouth for fast relief once an attack has started.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: stomach pain, drowsiness, thirst, headache, vomiting, and restlessness.

What should I watch out for?

Do not use this medicine for sudden breathing problems. Your healthcare provider may also prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem. Contact your healthcare provider if you need to use your inhaled medicine (for example, albuterol) more often than usual or if you need to use more than recommended during a 24-hour period. Do not stop taking other medicines for asthma or change your dosage unless your healthcare provider tells you to.

If you have aspirin-sensitive asthma, continue to avoid taking aspirin or any nonsteroidal anti-inflammatory medicines (NSAIDs) such as Advil, Motrin, or Aleve while you are taking this medicine. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Behavior changes have been reported in some people taking this medicine. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Depression or suicidal thoughts
• Memory problems

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worsening trouble breathing, seizures, irregular heartbeat, chest pain, severe rash, fever, severe sinus pain, tingling or numbness in arms and legs, unusual bruising or bleeding, unusual behavior or mood changes, confusion, hallucinations, depression, memory problems, thoughts of suicide, bad dreams, anxiety, sudden or severe stomach pain, severe nausea or vomiting.

Other: Headache, muscle aches and pains, tiredness, drowsiness, mild nausea, diarrhea, cough, stomach cramps, stuffy or runny nose, sore throat, earache, dizziness, heartburn.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Gemfibrozil (Lopid)
• Lumacaftor/ivacaftor (Orkambi)
• Rifampin (Rifadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.