Thursday, 14 June 2012

Zyflo CR Extended-Release Tablets


Pronunciation: zye-LOO-ton
Generic Name: Zileuton
Brand Name: Zyflo CR


Zyflo CR Extended-Release Tablets are used for:

Preventing and treating asthma in patients 12 years old and older. It may also be used for other conditions as determined by your doctor.


Zyflo CR Extended-Release Tablets are a leukotriene synthesis inhibitor. It works by blocking the formation of a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.


Do NOT use Zyflo CR Extended-Release Tablets if:


  • you are allergic to any ingredient in Zyflo CR Extended-Release Tablets

  • you have liver disease or abnormal liver function tests

  • you are taking astemizole, pimozide, or terfenadine

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



Before using Zyflo CR Extended-Release Tablets:


Some medical conditions may interact with Zyflo CR Extended-Release Tablets. 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 a history of liver problems (eg, hepatitis) or symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine)

  • if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions

  • if you drink alcohol

  • if you have trouble swallowing tablets

Some MEDICINES MAY INTERACT with Zyflo CR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased

  • Azole antifungals (eg, ketoconazole) because they may increase the risk of Zyflo CR Extended-Release Tablets's side effects

  • Astemizole, beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine), cisapride, cyclosporine, pimozide, terfenadine, or theophylline because the risk of their side effects may be increased by Zyflo CR Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zyflo CR Extended-Release Tablets 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 Zyflo CR Extended-Release Tablets:


Use Zyflo CR Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Zyflo CR Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.

  • Take Zyflo CR Extended-Release Tablets by mouth within 1 hour after the morning and evening meals, unless your doctor tells you otherwise.

  • Swallow Zyflo CR Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.

  • Take Zyflo CR Extended-Release Tablets on a regular schedule to get the most benefit from it. Taking Zyflo CR Extended-Release Tablets at the same times each day will help you remember to take it.

  • Continue to take Zyflo CR Extended-Release Tablets even if you feel well. Do not miss any doses.

  • If you miss a dose of Zyflo CR Extended-Release Tablets, 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 Zyflo CR Extended-Release Tablets.



Important safety information:


  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • It may take a few weeks before you get the full benefit of Zyflo CR Extended-Release Tablets. Do not stop using Zyflo CR Extended-Release Tablets without checking with your doctor.

  • Zyflo CR Extended-Release Tablets will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Zyflo CR Extended-Release Tablets (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.

  • Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it more often, or if you have a decrease in your peak flow meter results.

  • Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.

  • Talk with your doctor or pharmacist about all your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.

  • Some patients taking Zyflo CR Extended-Release Tablets have developed mental or mood changes, including sleep problems and behavior changes. Contact your doctor immediately if you experience any unusual symptoms while taking Zyflo CR Extended-Release Tablets.

  • Lab tests, including liver function, may be performed while you use Zyflo CR Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Zyflo CR Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially liver problems.

  • Zyflo CR Extended-Release Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zyflo CR Extended-Release Tablets while you are pregnant. It is not known if Zyflo CR Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Zyflo CR Extended-Release Tablets.


Possible side effects of Zyflo CR Extended-Release Tablets:


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:



Diarrhea; headache; muscle aches; nausea; nose irritation; sinus pain; symptoms of upper respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing); throat pain or irritation.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever, chills, or persistent sore throat; mental or mood changes; sleep problems; symptoms of liver problems (eg, dark urine; flu-like symptoms; pale stools; persistent loss of appetite; right upper stomach pain; unusual nausea, sluggishness, or tiredness; yellowing of the skin or eyes); unusual changes in behavior.



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: Zyflo CR 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.


Proper storage of Zyflo CR Extended-Release Tablets:

Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zyflo CR Extended-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Zyflo CR Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Zyflo CR Extended-Release Tablets 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 Zyflo CR Extended-Release Tablets. 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.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zyflo CR resources


  • Zyflo CR Side Effects (in more detail)
  • Zyflo CR Use in Pregnancy & Breastfeeding
  • Zyflo CR Drug Interactions
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