Montelukast Granules

Montelukast Granules are used for:

Prevention and long-term treatment of asthma. It is also used in certain patients to relieve allergy symptoms (eg, itchy, runny, or stuffy nose; sneezing) and to prevent asthma attacks caused by exercise. It may also be used for other conditions as determined by your doctor.

Montelukast Granules are a leukotriene receptor antagonist. It works by blocking a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.

Do NOT use Montelukast Granules if:

• you are allergic to any ingredient in Montelukast Granules

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Montelukast Granules:

Some medical conditions may interact with Montelukast Granules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems or if you drink alcohol
• if you have a history of mental or mood problems, or suicidal thoughts or actions
• if you have been taking a corticosteroid (eg, prednisone) and will be stopping it or lowering the dose

Some MEDICINES MAY INTERACT with Montelukast Granules. However, no specific interactions with Montelukast Granules are known at this time.

Ask your health care provider if Montelukast Granules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Montelukast Granules:

Use Montelukast Granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Montelukast Granules. Talk to your pharmacist if you have questions about this information.
• Take Montelukast Granules by mouth with or without food.
• Do not open the packet until you are ready to use it.
• Montelukast Granules may be placed directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of soft food at cold or room temperature before swallowing. Soft foods that may be used include applesauce, mashed carrots, rice, or ice cream. Be sure to swallow the entire spoonful right away (within 15 minutes). Do not store mixed medicine for future use.
• Do not put the granules in liquid other than baby formula or breast milk. However, you may drink liquids after swallowing the granules or granule mixture.
• Continue to use Montelukast Granules even if you feel well. Do not miss any doses.
• If you miss a dose of Montelukast Granules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Montelukast Granules.

Important safety information:

• Montelukast Granules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Montelukast Granules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Montelukast Granules will not stop an asthma attack once one has started. Be sure you always carry appropriate medicine (eg, bronchodilator inhalers) with you in case of an asthma attack.
• Contact your doctor right away if your short-acting inhaler use increases or if use exceeds the 24-hour maximum prescribed by your doctor. Contact your doctor if your asthma worsens.
• Do not decrease your dose or stop using Montelukast Granules or other asthma medicines without first checking with your doctor.
• If your asthma is sensitive to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), continue to avoid those medicines as directed by your doctor.
• Some patients taking Montelukast Granules have developed mental or mood changes, including suicidal thoughts or actions. Contact your doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact your doctor immediately if any signs of suicidal thoughts or actions occur.
• Tell your doctor or dentist that you take Montelukast Granules before you receive any medical or dental care, emergency care, or surgery.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Montelukast Granules while you are pregnant. It is not known if Montelukast Granules are found in breast milk. If you are or will be breast-feeding while you use Montelukast Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Montelukast Granules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; headache; indigestion; mild sore throat; mild stomach pain; nausea; runny or stuffy nose; stomach upset; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; confusion; dark urine; ear pain; fever, chills, or persistent sore throat; flu-like symptoms; irregular heartbeat; mental or mood changes (eg, agitation, aggression, hostility, anxiety, depression, strange dreams, sleepwalking, tremor, hallucinations, restlessness, irritability); new or worsening breathing problems; numbness or tingling of the hands or feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent stomach pain, with or without nausea or vomiting; sinus pain; suicidal thoughts or actions; swelling of the hands, ankles, or feet; tremor; trouble sleeping; unusual bruising or bleeding; upper respiratory infection; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Montelukast side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include hyperactivity; severe or persistent headache; stomach pain; unusual drowsiness or restlessness; unusual thirst; vomiting.

Store Montelukast Granules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Montelukast Granules out of the reach of children and away from pets.

General information:

• If you have any questions about Montelukast Granules, please talk with your doctor, pharmacist, or other health care provider.
• Montelukast Granules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Montelukast Granules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.