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Zyflo 600mg Tablet
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Indications & Clinical Uses
- Zyflo 600mg is an immediate-release tablet containing zileuton, an oral medicine used for the prevention and long-term (chronic) treatment of asthma in adults and children aged 12 years and older.
- It is a daily controller treatment taken as one 600 mg tablet four times a day, a total of 2400 mg daily, and is not a rescue medicine: it is not for reversing sudden asthma attacks or status asthmaticus.
- Use in children under 12 is not recommended.
- Zyflo is marketed in the US by Chiesi USA (earlier labels name Cornerstone Therapeutics).
- An extended-release zileuton product also exists, with different dosing, so the two must not be swapped without your prescriber's instruction.
Side Effects
- The most common side effects, seen in at least 3% of patients and more often than with placebo, are abdominal pain, nausea and indigestion (dyspepsia).
- Dizziness, difficulty sleeping (insomnia) and nervousness affected 1 to 3% of patients.
- Zyflo can raise liver enzymes: ALT rose to three times the upper limit of normal or more in about 1.9% of treated patients, compared with 0.2% on placebo.
- Reports since approval include sleep disorders and behavioural changes.
- Tell your healthcare provider promptly about yellow skin or eyes, dark urine, right-sided stomach pain, itching, unusual tiredness, or new mood or sleep changes.
- The US label carries no boxed warning.
Precautions & Warnings
- Liver blood tests (serum ALT) are needed before starting Zyflo, once a month for the first 3 months, every 2 to 3 months for the rest of the first year, and periodically after that.
- Zyflo must not be used if you have active liver disease or liver enzymes at or above three times the upper limit of normal, or if you are allergic to zileuton or any ingredient.
- It is not for treating sudden asthma attacks, so keep your rescue inhaler available.
- Pregnancy: use only if the potential benefit justifies the potential risk to the baby.
- It is not known whether zileuton passes into breast milk, so discuss breastfeeding with your provider.
- Not recommended under 12 years.
Avoid Interactions
- Increase the effect or toxicity: zileuton roughly doubles blood levels of theophylline, so the theophylline dose usually needs reducing with monitoring; it raises the blood-thinning effect of warfarin (prothrombin time rises) and needs close monitoring; and it roughly doubles exposure to propranolol, so a lower propranolol dose may be needed.
- Caution and monitoring are also advised with other medicines processed by CYP3A4.
- Reduce the effect: no medicines that lower zileuton's effect are described in the label sections reviewed.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and supplements before starting Zyflo.
References
Frequently Asked Questions
Zyflo (zileuton) is a tablet for the prevention and long-term treatment of asthma in adults and children aged 12 and older. It is a daily controller, not a rescue treatment, so it does not stop a sudden asthma attack. It is not recommended for children under 12.
Zyflo (zileuton) 600 mg is taken as one tablet four times a day, a total of 2400 mg daily. Tablets can be taken with meals or at bedtime without changing how well they are absorbed. Keep taking it regularly, even when your asthma feels well, unless your provider says otherwise.
Zyflo (zileuton) most often causes abdominal pain, nausea and indigestion. Dizziness, insomnia and nervousness are less common. It can raise liver enzymes, so report yellow skin or eyes, dark urine, right-sided stomach pain or unusual tiredness. Sleep problems and behaviour changes have also been reported.
Do not take Zyflo (zileuton) if you have active liver disease. Tell your provider if you use theophylline, warfarin or propranolol, because Zyflo raises their blood levels or effects and doses may need lowering. Do not rely on Zyflo for sudden asthma attacks; use your rescue inhaler.
Yes. Zyflo (zileuton) can raise liver enzymes, so ALT is tested before you start, monthly for 3 months, every 2 to 3 months for the rest of the first year, then periodically. Treatment is not for people whose ALT is three times the upper limit of normal or higher.
Zyflo (zileuton) is approved for children aged 12 and older. Use in children under 12 is not recommended because of the risk of liver toxicity. Any child taking it needs the same regular liver blood tests as adults, and the prescriber weighs the benefit and risk for each child.
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