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Singulair®

Brand Name: Singulair®
Active Ingredient:   montelukast sodium
Strength(s): 4 mg, 5 mg chewable tablets, and 10 mg oral tablets
Dosage Form(s):   Oral tablets and chewable tablets
Company Name:    Merck Research Laboratories
Availability:         Prescription only
*Date Approved by the FDA:   February 20, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Singulair used for? Singulair is taken to prevent and treat asthma.  The oral tablets are for asthma patients age 15 years and older, and the chewable tablets are for pediatric patients 2 years of age and older.  Do not take Singulair to relieve an asthma attack. It is not a replacement for the quick help that short acting inhalers provide during an asthma attack. It is very important that you continue taking your other asthma medicines unless your health care provider tells you to stop.

General Precautions with Singulair:

  • It is very important that you continue to take your other asthma medicines unless your doctor tells you to stop.
  • If your asthma is made worse by aspirin, you should continue to avoid aspirin or other non-steroidal anti-inflammatory drugs.
  • Phenylketonuric patients should be aware that the chewable tablet for Singulair contains phenylalanine (a part of aspartame).

What should I tell my doctor or health care provider?

  • Tell your doctor or health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

What are some possible side effects of Singulair? (This list is NOT a complete list of side effects reported with Singulair. Your health care provider can discuss with you a more complete list of side effects.)

  • Feeling tired
  • Fever
  • Stomach pain 
  • Upset stomach
  • Intestinal upset
  • Heartburn
  • Dizziness
  • Headache

Reports of patients’ experiences after Singulair became available include:

  • Allergic reactions including swelling of the face, lips, tongue, and/or throat, (which may cause difficulty in breathing or swallowing), hives, and itching. Stop taking Singulair and call your doctor if you experience any of these symptoms.
  • A rare condition, that includes a combination of certain symptoms which do not go away or get worse, including a flu-like illness, rash, pins and needles or numbness of arms or legs, and severe inflammation of the sinuses. These have usually occurred, but not always, in people whose oral steroid medicines for asthma were being gradually lowered or stopped. Although Singulair has not been shown to cause this condition, you must tell your doctor right away if you get one or more of these symptoms.
  • For more detailed information about Singulair, ask your health care provider.

    http://www.fda.gov/cder/foi/label/1998/20829lbl.pdf    Link to Singulair's approved label and patient information

    Updated: 11/19/99
    Updated: 3/28/00
    Revised: 7/25/00, 6/22/01

     

    Back to Drug Side Effects


    source: FDA


    last update: December 2004





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