What are the details of your prescription?
Accolate
Generic Name: Zafirlukast
Drug Category: Leukotriene Antagonist
Litigation Alert Level: Withdrawn
This drug has been approved for use by males and females over the age of 5 years old for a maximum duration of 52 weeks.
| Approved Uses |
|
The manufacturer of zafirlukast (Accolate) has discontinued this product in 2018. Indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older. ACCOLATE is contraindicated in patients with hepatic impairment including hepatic cirrhosis. ACCOLATE is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with ACCOLATE can be continued during acute exacerbations of asthma. The safety and effectiveness of zafirlukast for pediatric patients less than 5 years of age has not been established. The effect of ACCOLATE on growth in children has not been determined. Neuropsychiatric adverse events, including insomnia and depression, have been reported in association with ACCOLATE therapy. Women who are breastfeeding should be instructed not to take ACCOLATE. |
| Off-label Uses |
|
• Use in patients under the age of 5. GoToSource • Capsular contracture post-breast implantation. GoToSource • Hay fever and allergies. GoToSource • Cystic fibrosis. GoToSource • Exercise induced asthma, rhinitis, chronic obstructive pulmonary disease, interstitial lung disease, chronic urticaria, atopic dermatitis, allergic fungal disease, nasal polyposis, and paranasal sinus disease, migraines, respiratory syncytial virus post bronchiolitis, systemic mastocytosis, pancreatitis, cancer, atherosclerosis, eosinophils cystitis, otitis media and eosinophilic gastrointestinal disorders. GoToSource • Severe recurrent vulvovaginal candidiasis. GoToSource |
| Adverse Events |
|
Agitation, aggression, anxiousness, hallucinations, depression, insomnia, irritability, restlessness and suicidal thinking and behavior. GoToSource Tolerance, withdrawal symptoms and blood neutrophilia. GoToSource Acute hepatitis (liver inflammation). GoToSource Pulmonary infiltrates, cardiomyopathy, leukocytosis and peripheral blood eosinophilia. GoToSource Churg strauss syndrome (fever, weight loss, malaise, increasing cough/dyspnea with decline in pulmonary function, pulmonary infiltrates in the absence of infection, eosinophilia, cardiac involvement, peripheral neuropathy, glomerulonephritis or palpable purpura). GoToSource |
| Litigation |
|
Lawsuits filed for liver failure. |
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