Accolate
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Questions & Answers
Side Effects & Adverse Reactions
Cases of life-threatening hepatic failure have been reported in patients treated with ACCOLATE. Cases of liver injury without other attributable cause have been reported from post-marketing adverse event surveillance of patients who have received the recommended dose of ACCOLATE (40 mg/day). In most, but not all post-marketing reports, the patient’s symptoms abated and the liver enzymes returned to normal or near normal after stopping ACCOLATE. In rare cases, patients have either presented with fulminant hepatitis or progressed to hepatic failure, liver transplantation and death. In extremely rare post-marketing cases, no clinical symptoms or signs suggestive of liver dysfunction were reported to precede the latter observations.
Physicians may consider the value of liver function testing. Periodic serum transaminase testing has not proven to prevent serious injury but it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery.
Patients should be advised to be alert for signs and symptoms of liver dysfunction (eg, right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia) and to contact their physician immediately if they occur. Ongoing clinical assessment of patients should govern physician interventions, including diagnostic evaluations and treatment.
If liver dysfunction is suspected based upon clinical signs or symptoms (eg, right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, anorexia, and enlarged liver), ACCOLATE should be discontinued.
Liver function tests, in particular serum ALT, should be measured immediately and the patient managed accordingly. If liver function tests are consistent with hepatic dysfunction, ACCOLATE therapy should not be resumed. Patients in whom ACCOLATE was withdrawn because of hepatic dysfunction where no other attributable cause is identified should not be re-exposed to ACCOLATE (see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS).
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.
Coadministration of zafirlukast with warfarin results in a clinically significant increase in prothrombin time (PT). Patients on oral warfarin anticoagulant therapy and ACCOLATE should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see PRECAUTIONS, Drug Interactions).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ACCOLATE is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:
The empirical formula is: C31H33N3O6S
Zafirlukast, a fine white to pale yellow amorphous powder, is practically insoluble in water. It is slightly soluble in methanol and freely soluble in tetrahydrofuran, dimethylsulfoxide, and acetone.
ACCOLATE is supplied as 10 and 20 mg tablets for oral administration.
Inactive Ingredients: Film-coated tablets containing croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide.
Sources
Accolate Manufacturers
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Par Pharmaceutical Inc.
![Accolate (Zafirlukast) Tablet, Film Coated [Par Pharmaceutical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Accolate | Par Pharmaceutical Inc.
Because food can reduce the bioavailability of zafirlukast, ACCOLATE should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and olderThe recommended dose of ACCOLATE in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of ageThe recommended dose of ACCOLATE in children 5 through 11 years of age is 10 mg twice daily.
Elderly PatientsBased on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that Cmax and AUC are approximately twice those of younger adults. In clinical trials, a dose of 20 mg twice daily was not associated with an increase in the overall incidence of adverse events or withdrawals because of adverse events in elderly patients.
Patients with Hepatic ImpairmentACCOLATE is contraindicated in patients with hepatic impairment including hepatic cirrhosis (see Contraindications). The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the Cmax and AUC are approximately 50 - 60% greater than those of normal adults. ACCOLATE has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis.
Patients with Renal ImpairmentDosage adjustment is not required for patients with renal impairment.
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State Of Florida Doh Central Pharmacy
Accolate | State Of Florida Doh Central Pharmacy
Because food can reduce the bioavailability of zafirlukast, ACCOLATE should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and olderThe recommended dose of ACCOLATE in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of ageThe recommended dose of ACCOLATE in children 5 through 11 years of age is 10 mg twice daily.
Elderly Patients: Based on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that Cmax and AUC are approximately twice those of younger adults. In clinical trials, a dose of 20 mg twice daily was not associated with an increase in the overall incidence of adverse events or withdrawals because of adverse events in elderly patients.
Patients with Hepatic Impairment: The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the Cmax and AUC are approximately 50 - 60% greater than those of normal adults. ACCOLATE has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis.
Patients with Renal Impairment: Dosage adjustment is not required for patients with renal impairment.
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Astrazeneca Pharmaceuticals Lp
Accolate | Astrazeneca Pharmaceuticals Lp
Because food can reduce the bioavailability of zafirlukast, ACCOLATE should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and olderThe recommended dose of ACCOLATE in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of ageThe recommended dose of ACCOLATE in children 5 through 11 years of age is 10 mg twice daily.
Elderly PatientsBased on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that Cmax and AUC are approximately twice those of younger adults. In clinical trials, a dose of 20 mg twice daily was not associated with an increase in the overall incidence of adverse events or withdrawals because of adverse events in elderly patients.
Patients with Hepatic ImpairmentACCOLATE is contraindicated in patients with hepatic impairment including hepatic cirrhosis (see Contraindications). The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the Cmax and AUC are approximately 50 - 60% greater than those of normal adults. ACCOLATE has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis.
Patients with Renal ImpairmentDosage adjustment is not required for patients with renal impairment.
![Accolate (Zafirlukast) Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4bf90772-58d5-456d-ad1c-fc448cc5a231&name=Accolate20mg(AstraZeneca).jpg)
![Accolate (Zafirlukast) Tablet, Film Coated [Astrazeneca Pharmaceuticals Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5550433b-8c9c-4378-058f-6bb724c4f18c&name=2b0262a7-3717-4db6-8be7-f419812dda5f-03.jpg)
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