Zafirlukast 20 mg/1
Zafirlukast · TABLET, FILM COATED · American Health Packaging
Zafirlukast is a tablet, film coated containing zafirlukast at 20 mg/1, taken oral. Manufactured by American Health Packaging.
Key Facts
- Brand Name
- Zafirlukast
- Generic Name
- Zafirlukast
- NDC Code (Product)
68084-059- Manufacturer
- American Health Packaging
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090372
- Drug Class
- Leukotriene Receptor Antagonist [EPC]
- Marketing Start
- 06/03/2013
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 C max 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 C max and AUC are approximately 50 to 60% greater than those of normal adults. Zafirlukast has not …
Warnings
WARNINGS 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 …
Contraindications
CONTRAINDICATIONS Zafirlukast is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients. Zafirlukast is contraindicated in patients with hepatic impairment including hepatic cirrhosis.
Drug Interactions
Drug Interactions In a drug interaction study in 16 healthy male volunteers, coadministration of multiple doses of zafirlukast (160 mg/day) to steady-state with a single 25 mg dose of warfarin resulted in a significant increase in the mean AUC (+ 63%) and half-life (+36%) of S-warfarin. The mean prothrombin time (PT) increased by approximately 35%. This interaction is probably due to an inhibition by zafirlukast of the cytochrome P450 2C9 isoenzyme system. Patients on oral warfarin anticoagulant therapy and zafirlukast should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see WARNINGS , Concomitant Warfarin Administration ). No formal drug-drug interaction studies with zafirlukast and other drugs known to be metabolized by the cytochrome P450 2C9 isoenzyme (eg, tolbutamide, phenytoin, carbamazepine) have been conducted; however, care should be exercised when zafirlukast is coadministered with these drugs. In a drug interaction study in 11 asthmatic patients, coadministration of a single dose of zafirlukast (40 mg) with erythromycin (500 mg three times daily for 5 days) to steady-state resulted in decreased mean plasma levels of zafirluka…
Adverse Reactions
ADVERSE REACTIONS Adults and Children 12 years of age and older The safety database for zafirlukast consists of more than 4,000 healthy volunteers and patients who received zafirlukast, of which 1,723 were asthmatics enrolled in trials of 13 weeks duration or longer. A total of 671 patients received zafirlukast for 1 year or longer. The majority of the patients were 18 years of age or older; however, 222 patients between the age of 12 and 18 years received zafirlukast. A comparison of adverse events reported by ≥1% of zafirlukast-treated patients, and at rates numerically greater than in placebo-treated patients, is shown for all trials in the table below. Adverse Event Zafirlukast N=4,058 PLACEBO N=2,032 Headache 12.9% 11.7% Infection 3.5% 3.4% Nausea 3.1% 2.0% Diarrhea 2.8% 2.1% Pain (generalized) 1.9% 1.7% Asthenia 1.8% 1.6% Abdominal Pain 1.8% 1.1% Accidental Injury 1.6% 1.5% Dizziness 1.6% 1.5% Myalgia 1.6% 1.5% Fever 1.6% 1.1% Back Pain 1.5% 1.2% Vomiting 1.5% 1.1% SGPT Elevation 1.5% 1.1% Dyspepsia 1.3% 1.2% The frequency of less common adverse events was comparable between zafirlukast and placebo. Rarely, elevations of one or more liver enzymes have occurred in patients rec…
Frequently Asked Questions
What is Zafirlukast used for?
Zafirlukast contains Zafirlukast. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Zafirlukast a controlled substance?
Zafirlukast is not classified as a controlled substance by the DEA.
What is the generic name for Zafirlukast?
The generic name for Zafirlukast is Zafirlukast. There are no other listed brand versions of Zafirlukast.
What is the NDC code for Zafirlukast 20 mg/1?
The NDC (National Drug Code) for Zafirlukast 20 mg/1 is 68084-059, listed by American Health Packaging.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)