Tablets Accolate Prescription (zafirlukast), Singulair (montelukast), Zyflo
is indicated for children greater than 12 years of age for the treatment of chronic asthma.
Montelukast (Singulair) is approved for use in children aged [greater than or equal to] 12 months, zafirlukast (Accolate) is approved for children aged [greater than or equal to] 5 years, and zileuton (Zyflo
) is approved only for children aged > 12 years.
He or she may recommend adjusting dosage levels or replacing corticosteroid therapy with alternative drugs such as leukotriene modifiers (Singulair; Zyflo
), mast cell stabilizers (Crolom; Nasalcrom; Tilade), or the antibody Omalizumab (Xolair), which prevents the release of inflammatory chemicals that narrow the airways.
The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo
The FDA is also reviewing postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who took other leukotriene-modifying therapies, including zafirlukast (Accolate) and zileuton (Zyflo
The FDA is also reviewing reports of suicide and behavioral changes in people who took AstraZeneca Plc's Accolate and Critical Therapeutics Inc.'s Zyflo
CR, three asthma medicines that are similar to Singulair.
There are no published data on zileuton (Zyflo
) use in humans, but the drug should be avoided because it has been found to be teratogenic and fetotoxic in animals.
Zileuton is available only in an immediate-release formulation marketed as Zyflo
, dosed at 600 mg four times daily.
Three of these agents are on the market now: montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo
Another drug on the list is the leukotriene modifier zileuton (Zyflo
), which is approved to treat asthma, but reportedly has been used to help recalcitrant itching.
The most important difference among these drugs is the propensity of astemizole (Hismanal) to interact with antibiotics, antifungals, the antiasthma medication zileuton (Zyflo
), and the serotonin selective reuptake inhibitor antidepressants, such as paroxetine and sertraline.