Zafirlukast

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Side Effects & Adverse Reactions

Hepatotoxicity:

Cases of life-threatening hepatic failure have been reported in patients treated with zafirlukast. 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 zafirlukast (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 zafirlukast. 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), zafirlukast 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, zafirlukast therapy should not be resumed. Patients in whom zafirlukast was withdrawn because of hepatic dysfunction where no other attributable cause is identified should not be re-exposed to zafirlukast (see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS).

Bronchospasm:

Zafirlukast tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with zafirlukast can be continued during acute exacerbations of asthma.

Concomitant Warfarin Administration:

Coadministration of zafirlukast with warfarin results in a clinically significant increase in prothrombin time (PT). Patients on oral warfarin anticoagulant therapy and zafirlukast should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see PRECAUTIONS, Drug Interactions).

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

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History

There is currently no drug history available for this drug.

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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 molecular formula is: C31H33N3O6S

Zafirlukast, white to pale yellow coloured powder, freely soluble in tetrahydrofuran, and dimethylsulfoxide and practically insoluble in water.

Zafirlukast is supplied as 10 and 20 mg tablets for oral administration.

Inactive ingredients: Film coated tablets containing hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate (Type-A) and titanium dioxide. .

Sources

Zafirlukast Manufacturers

Dr. Reddys Laboratories Limited

Zafirlukast | Dr. Reddys Laboratories Limited

Because food can reduce the bioavailability of zafirlukast, zafirlukast tablets should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of zafirlukast tablets in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of zafirlukast tablets 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. Zafirlukast 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

Zafirlukast | Astrazeneca Pharmaceuticals Lp

Because food can reduce the bioavailability of zafirlukast, zafirlukast should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of zafirlukast in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of zafirlukast 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: Zafirlukast 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. Zafirlukast 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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Par Pharmaceutical Inc.

Zafirlukast | Par Pharmaceutical Inc.

Because food can reduce the bioavailability of zafirlukast, zafirlukast should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of zafirlukast in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of zafirlukast 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
Zafirlukast 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. Zafirlukast 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.

No Recall
American Health Packaging

Zafirlukast | American Health Packaging

Because food can reduce the bioavailability of zafirlukast, zafirlukast tablets should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of zafirlukast tablets in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of zafirlukast tablets 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: Zafirlukast 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. Zafirlukast 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.

No Recall
Carilion Materials Management

Zafirlukast | Carilion Materials Management

Because food can reduce the bioavailability of zafirlukast, zafirlukast tablets should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of zafirlukast tablets in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of zafirlukast tablets in children 5 through 11 years of age is 10 mg twice daily.

Based on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that C 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. Elderly Patients:max

The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the C and AUC are approximately 50 - 60% greater than those of normal adults. Zafirlukast has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis. Patients with Hepatic Impairment:max

Dosage adjustment is not required for patients with renal impairment. Patients with Renal Impairment:

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