ZILEUTON (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Antiasthmatic (leukotriene inhibitor)
Description
Zileuton (zye-LOO-ton) is used by patients withmild to moderate chronic asthma to decrease the symptoms of asthma and thenumber of acute asthma attacks. However, this medicine should not be takento relieve an asthma attack that has already started.
This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For zileuton, the followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to zileuton.
Pregnancy?Zileuton has not been studied in pregnant women.However, studies in rabbits have shown that this medicine causes problemswhen given in doses equal to the maximum human dose. Before taking this medicine,make sure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding?Zileuton passes into breast milk and may causeunwanted effects in nursing babies. Taking zileuton is not recommended whileyou are breast-feeding.
Children?Studies on this medicine have been done only in adultpatients and there is no specific information comparing use of zileuton inchildren up to 12 years of age with use in other age groups.
Older adults?This medicine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingzileuton, it is especially important that your health care professional knowif you are taking any of the following:
- Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol[e.g., Tenormin], betaxolol [e.g., Betoptic, Kerlone], bisoprolol [e.g., Zebeta],carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], levobunolol [e.g.,Betagan], metipranolol [e.g., Optipranolol], metoprolol [e.g., Lopressor],nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol],pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor],timolol [e.g., Blocadren, Timoptic]) or
- Terfenadine (e.g., Seldane) or
- Theophylline (e.g., Theo Dur) or
- Warfarin (e.g., Coumadin)?Zileuton may increase the effectsof these medicines
Other medical problems?The presence of other medicalproblems may affect the use of zileuton. Make sure you tell your doctor ifyou have any other medical problems, especially:
- Active alcoholism or
- Liver disease?The chance of serious side effects may be increased
Proper Use of This Medicine
Zileuton is used to prevent asthma attacks. It is not used to relieve an attackthat has already started. For relief of an asthma attack that has alreadystarted, you should use another medicine. If you do not have another medicineto use for an attack or if you have any question about this, check with yourhealth care professional.
Dosing?Follow your doctor's ordersor the directions on the label. The following information includesonly the average doses of zileuton. If your dose is different,do not change it unless your doctor tells you to do so.
- For oral dosage form (tablets):
- For asthma:
- Adults and children 12 years of age and older?600 milligrams(mg) four times a day.
- Children up to 12 years of age?Use and dose must be determinedby your doctor.
Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
To workproperly, zileuton must be taken every day at regularlyspaced times, even if your asthma seems better.
It is very important that your doctor check your progress at regular visits. Your doctor will want to have certain tests done regularlyto see if side effects may be occurring in your liver without your knowingit.
Check with your health care professional if more inhalations(puffs) than usual of an inhaled, short-acting bronchodilator are needed torelieve an acute attack or if more than the maximum number of puffs of thebronchodilator prescribed for a 24-hour period are needed.
You may be taking other medicines for asthma along with zileuton. Do not stop taking or reduce the dose of the other medicines,even if your asthma seems better, unless you are told to do so by your healthcare professional.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.
Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:
Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.
Revised: 03/22/1999
