Generic Name: Zafirlukast
Class: Leukotriene Modifiers
ATC Class: R03DC01
VA Class: RE109
Chemical Name: [3-[[2-Methoxy-4-[[[(2-methylphenyl)-sulfonyl]amino]carbonyl]phenyl]methyl]-1H-indol-5-yl-carbamic acid cyclopentyl ester
Molecular Formula: C31H33N3O6S
CAS Number: 107753-78-6
Uses for Accolate
In patients with mild persistent asthma, low-dose orally inhaled corticosteroids considered first-line agents for long-term control.43 74 Alternative agents, including certain leukotriene modifiers (i.e., zafirlukast, montelukast), may be used but are less effective than inhaled corticosteroids and are not preferred as initial therapy.43 74 76
In patients with moderate persistent asthma, low-dose inhaled corticosteroids with a long-acting inhaled β2-agonist bronchodilator (e.g., salmeterol, formoterol) or monotherapy with medium-dose inhaled corticosteroids preferred.43 74 However, the National Asthma Education and Prevention Program (NAEPP) recommends that beneficial effects of long-acting inhaled β2-agonists be weighed carefully against increased risk of severe asthma exacerbations and asthma-related deaths associated with daily use of such agents.74
Alternative agents, including certain leukotriene modifiers (i.e., zafirlukast, montelukast), can be added to a low dosage of inhaled corticosteroid for treatment of moderate persistent asthma, but these options are less effective.43 74 Considerations favoring combination with orally inhaled corticosteroids include intolerance to long-acting β2-adrenergic agonists, marked preference for oral therapy, and demonstration of superior responsiveness to these leukotriene modifiers.74
In adults and children ≥5 years of age with severe persistent asthma, NAEPP and the Global Initiative for Asthma (GINA) state that maintenance therapy with inhaled corticosteroids at medium to high dosages and adjunctive therapy with a long-acting inhaled β2-agonist is preferred.43 74 Alternatives to a long-acting inhaled β2-agonist in such patients receiving medium-dose inhaled corticosteroids include certain leukotriene modifiers (i.e., zafirlukast, montelukast), but these agents are generally not preferred.43 74
Accolate Dosage and Administration
Children 5–11 years of age: 10 mg twice daily.1
Clearance may be decreased.1 Dosage reduction may be necessary;53 however, the manufacturer currently makes no specific recommendations for dosage adjustment.1 45 Not evaluated in patients with hepatitis or in long-term studies in patients with cirrhosis.1 45 (See Special Populations under Absorption and under Elimination in Pharmacokinetics and see Hepatic Impairment.)
Cautions for Accolate
Known hypersensitivity to zafirlukast or any ingredient in the formulation.1
Hepatic dysfunction, including increases in liver enzyme concentrations, hepatitis, and/or hyperbilirubinemia, reported.1 52 Zafirlukast-induced hepatotoxicity usually is reversible following discontinuance of the drug.1 52
Monitor closely for signs and symptoms of hepatic impairment; consider performing liver function tests (e.g., serum AST and ALT) periodically.1 Advise patients to immediately contact their clinician if they notice signs and symptoms of liver dysfunction.1
Discontinue therapy if signs and/or symptoms suggestive of liver dysfunction occur; immediately perform liver function tests (i.e., serum ALT) and manage patient accordingly.52
Do not reinitiate therapy if results of liver function tests are consistent with hepatic dysfunction or if zafirlukast was discontinued because of hepatic dysfunction when no other attributable cause could be identified.1
Do not use for relief of acute bronchospasm (including status asthmaticus); zafirlukast can be continued during acute exacerbations of asthma, but it will not provide immediate symptomatic relief.1 45 52 Patients who experience exacerbations of asthma should continue their usual regimen of inhaled β2–adrenergic agonists for prophylaxis and have a short-acting orally inhaled β2-adrenergic agonist available for rescue.1 11 45 52
Eosinophilia and Churg-Strauss Syndrome
Systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome reported rarely in patients receiving leukotriene modifiers; these events usually associated with reduction (tapered dosage) or withdrawal of oral or high-dose inhaled corticosteroid therapy.1 57 58 59 60 61 62 63 64
Concomitant Corticosteroid Therapy
Do not abruptly substitute zafirlukast for oral or inhaled corticosteroids. Orally inhaled corticosteroid requirements may be reduced during zafirlukast therapy; undertake only gradual (e.g., at 2-week intervals) reduction of corticosteroid dosage.1 45 52 53
Neuropsychiatric events reported with zafirlukast during postmarketing experience.75 80 81 Data from placebo-controlled trials with leukotriene modifiers indicate that suicidal ideation occurred in 0.01% of 9929 patients treated with montelukast and in none of those receiving other leukotriene modifiers; no completed suicide occurred during therapy with any leukotriene modifier.80 FDA concluded that some neuropsychiatric events reported with zafirlukast (e.g., depression, insomnia) appear consistent with a drug-induced effect.1 81
Be alert to the potential for neuropsychiatric events in patients receiving the drug.1 81 Instruct patients to contact their clinician if behavior or mood changes occur.1 81 Carefully evaluate the risks and benefits of continuing zafirlukast therapy in patients who develop neuropsychiatric symptoms.1 81
ACOG generally recommends use of leukotriene receptor antagonists (i.e., zafirlukast, montelukast) as alternatives to a long-acting β2-agonist in pregnant women with moderate persistent asthma who are inadequately controlled with low to medium dosages of an inhaled corticosteroid.66 (See Asthma under Uses.)
Safety demonstrated in children 5–11 years of age; efficacy extrapolated from demonstrated efficacy in adults with asthma and the likelihood that the disease course, pathophysiology, and drug’s effect are similar between the two populations.1
Safety and efficacy not established in children <5 years of age.1
Increased systemic exposure and AUC, reflecting decreased clearance in children relative to adults.1
Effect on growth in pediatric patients not evaluated in clinical studies to date.1
Common Adverse Effects
Interactions for Accolate
Metabolized by CYP2C9.1
Inhibits CYP3A4 and CYP2C9.1
Drugs Metabolized by Hepatic Microsomal Enzymes
CYP2C9 and CYP3A4 substrates: Potential pharmacokinetic interaction (increased plasma substrate concentrations).1
Anticonvulsants (e.g., carbamazepine, phenytoin)
Possible increased plasma anticonvulsant concentrationsa
Monitor for adverse effects1
Monitor for alterations in clinical response and/or adverse effects1
Astemizole (no longer commercially available in the US)
Calcium-channel blocking agents, dihydropyridine (nicardipine, nifedipine)
Cisapride (commercially available in US only under limited-access protocol)
Contraceptives, oral (fixed dose estrogen-progestin combination)
Monitor for alterations in clinical response and/or adverse effects1
Terfenadine (no longer commercially available in US)
No alteration in terfenadine pharmacokinetics; no effect on QTc interval45
Monitor for alterations in clinical response and/or adverse effects1
Possible increased plasma tolbutamide concentrationsa
Monitor for adverse effects1
Steady-state plasma concentrations are proportional to dose.a
Children 5–11 years of age: Increased peak plasma concentrations, AUC, and systemic exposure.1
Plasma Protein Binding
Clearance is reduced in children 5–11 years of age and adults >65 years of age.1
Clearance is reduced in patients with hepatic impairment.1
Pharmacokinetics not affected by gender, race, or renal function.1
20–25°C; protect from light and moisture.1
Binds selectively and with high affinity to a group of cysteinyl leukotriene receptors (CysLT1) in airway smooth muscle and competitively inhibits the action of LTD4 and LTE4 (cysteinyl leukotrienes) at these receptors. 1 2 3 4 5 6 11 12 13 18 19 20 21 23 24 45 53
Modification of leukotriene activity may be used to reduce symptoms of asthma since cysteinyl leukotrienes are especially important in the pathogenesis of asthma, causing increased mucous secretion and vascular permeability, airway edema, bronchoconstriction, and altered cellular activity associated with the inflammatory process.1 5 6 7 9 12 13 20 21 22 23 24 26 28 45 53
Inhibits bronchoconstriction induced by exposure to known precipitating factors (e.g., allergens, environmental pollutants, cold and/or dry air, exercise);1 2 6 7 9 12 13 20 22 23 44 45 48 49 50 51 53 55 inhibits both the acute bronchoconstrictor response and the delayed inflammatory response to inhaled antigens.1 2 6 7 10 12 21 22 44 45 55
Advice to Patients
Risk of hepatotoxicity; importance of patients immediately informing their clinicians if right upper quadrant pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, or anorexia occurs.1
Importance of taking zafirlukast at regular intervals, when asymptomatic as well as during periods of worsening asthma.1
Importance of contacting clinician if asthma is not well controlled; seek medical attention if short-acting, inhaled β2-adrenergic bronchodilators are needed more often than usual or if more than the maximum number of inhalations for a 24-hour period are needed.1
Importance of not using zafirlukast for the relief of acute bronchospasm.1 Patients should be provided with and instructed in the use of a short-acting, inhaled β2-adrenergic bronchodilator as supplemental therapy for acute asthma symptoms.1
If patient experiences exacerbations of asthma after exercise, necessity of continuing the usual regimen of inhaled β2-adrenergic agonist for prophylaxis and of having a short-acting, orally inhaled β2-adrenergic agonist available for rescue.1
Importance of informing clinicians of existing or concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Accolate 10MG Tablets (ASTRAZENECA): 60/$120.99 or 180/$340.96
Accolate 20MG Tablets (ASTRAZENECA): 60/$129.99 or 180/$375.96
Zafirlukast 10MG Tablets (PAR): 60/$89.99 or 180/$249.97
Zafirlukast 20MG Tablets (PAR): 60/$89.99 or 180/$249.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions April 24, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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a. AstraZeneca Pharmaceuticals. Accolate (zafirlukast) tablets prescribing information. Wilmington, DE; 2004 July.
b. AHFS drug information 2006. McEvoy GK, ed. Montelukast. Bethesda, MD: American Society of Health-System Pharmacists; 2006:2698-704.
More Accolate resources
- Accolate Prescribing Information (FDA)
- Accolate MedFacts Consumer Leaflet (Wolters Kluwer)
- Accolate Concise Consumer Information (Cerner Multum)
- Accolate Advanced Consumer (Micromedex) - Includes Dosage Information
- Zafirlukast Prescribing Information (FDA)
- Zafirlukast Professional Patient Advice (Wolters Kluwer)