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Singulair granules

Pronunciation

Generic Name: montelukast (MON-te-LOO-kast)
Brand Name: Singulair

Singulair granules is 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.

Singulair granules is a leukotriene receptor antagonist. It works by blocking a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.

Do NOT use Singulair granules if:

  • you are allergic to any ingredient in Singulair granules

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Singulair granules:

Some medical conditions may interact with Singulair 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 Singulair granules. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Singulair 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 Singulair granules:

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

  • An extra patient leaflet is available with Singulair granules. Talk to your pharmacist if you have questions about this information.
  • Take Singulair granules by mouth with or without food.
  • Do not open the packet until you are ready to use it.
  • Singulair 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 Singulair granules even if you feel well. Do not miss any doses.
  • If you miss a dose of Singulair 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 Singulair granules.

Important safety information:

  • Singulair granules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Singulair granules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Singulair 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 Singulair 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 Singulair 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 Singulair 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 Singulair granules while you are pregnant. It is not known if Singulair granules is found in breast milk. If you are or will be breast-feeding while you use Singulair granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Singulair 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.

Seek medical attention right away if any of these SEVERE side effects occur:

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.

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.

Proper storage of Singulair granules:

Store Singulair 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 Singulair granules out of the reach of children and away from pets.

General information:

  • If you have any questions about Singulair granules, please talk with your doctor, pharmacist, or other health care provider.
  • Singulair granules is 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 should not be used to decide whether or not to take Singulair granules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Singulair granules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Singulair granules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Singulair granules.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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