Zileuton 600 mg/1
zileuton · TABLET, MULTILAYER, EXTENDED RELEASE · Golden State Medical Supply, Inc.
Zileuton is a tablet, multilayer, extended release containing zileuton at 600 mg/1, taken oral. Manufactured by Golden State Medical Supply, Inc..
Key Facts
- Brand Name
- Zileuton
- Generic Name
- zileuton
- NDC Code (Product)
51407-741- Manufacturer
- Golden State Medical Supply, Inc.
- Strength
- 600 mg/1
- Dosage Form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212670
- Drug Class
- 5-Lipoxygenase Inhibitor [EPC]
- Marketing Start
- 12/16/2019
Recall History
Chiesi USA, Inc.
Failed Dissolution Specifications: Out of specification result for dissolution.
Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Chiesi USA, Inc.
Failed Dissolution Specifications: Out of specification result for dissolution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma. Zileuton extended-release tablets are a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ( 1 ) Do not use zileuton extended-release tablet to treat an acute asthma attack. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of zileuton extended-release tablets for the treatment of patients with asthma is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. Tablets should not be chewed, cut or crushed. If a dose is missed, the patient should take the next dose at the scheduled time and not double the dose. Assess hepatic function enzymes prior to initiation of zileuton extended-release tablets and periodically during treatment [see Contraindications ( 4 ), Warnings and Precautions ( 5 ), and Use in Specific Populations ( 8.7 ) ]. Adults and children 12 years of age and older: The recommended dose of zileuton extended-release tablets is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. ( 2 ) Monitoring: Assess hepatic function enzymes prior to initiation of zileuton extended-release tablet and monitor periodically during treatment. ( 2 , 5.1 )
Contraindications
4 CONTRAINDICATIONS The use of zileuton extended-release tablets are contraindicated in patients with: • Active liver disease or persistent hepatic function enzyme elevations greater than or equal to 3 times the upper limit of normal (≥3xULN) [see Warnings and Precautions ( 5 ), and Use in Specific Populations ( 8.7 ) ]. • A history of allergic reaction to zileuton or any of the ingredients of zileuton extended-release tablets (e.g., rash, eosinophilia, etc.). • Active liver disease or persistent hepatic function enzyme elevations ≥3 times the upper limit of normal. ( 4 , 5.1 ) • History of allergic reaction to zileuton or any of the ingredients of zileuton extended-release tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The following study results were obtained using zileuton immediate-release tablets but the conclusions also apply to zileuton extended-release tablets. • Zileuton increases theophylline levels. Reduce theophylline dose and monitor levels. ( 7.1 ) • Zileuton increases warfarin levels. Monitor prothrombin time and adjust warfarin dose accordingly. ( 7.2 ) • Zileuton increases propranolol levels and beta-blocker activity. Monitor appropriately. ( 7.3 ) 7.1 Theophylline In a drug-interaction study in 16 healthy subjects, co-administration of multiple doses of zileuton immediate-release tablets (800 mg every 12 hours) and theophylline (200 mg every 6 hours) for 5 days resulted in a significant decrease (approximately 50%) in steady-state clearance of theophylline, an approximate doubling of theophylline AUC, and an increase in theophylline C max (by 73%). The elimination half-life of theophylline was increased by 24%. Also, during co-administration, theophylline-related adverse reactions were observed more frequently than after theophylline alone. Upon initiation of zileuton extended-release tablets in patients receiving theophylline, the theophylline dosage should b…
Adverse Reactions
6 ADVERSE REACTIONS Hepatotoxicity: Elevations of one or more hepatic function enzymes and bilirubin may occur during zileuton extended-release tablets therapy [see Warnings and Precautions ( 5 ) ]. The most commonly occurring adverse reactions (≥5%) with zileuton extended-release tablets are sinusitis, nausea, and pharyngolaryngeal pain. Most common adverse reactions (≥5%) included: sinusitis, nausea, and pharyngolaryngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Short-Term Clinical Studies Experience The safety data described below reflect exposure to zileuton extended-release tablets in 199 patients for 12 weeks duration. In a 12-week, randomized, double-blind, placebo-controlled trial in adults and adolescents 12 years of age and older with asthma, patients received zileuton extended-release tablets two 600 mg tablets (n=199) or placebo (n=198) twice daily by mouth. Eighty-three percent of patients were white, 48% were male, and the mean age was 34 years. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed i…
Frequently Asked Questions
What is Zileuton used for?
Zileuton contains zileuton. It is a tablet, multilayer, extended release taken oral. Consult your doctor for specific uses.
Is Zileuton a controlled substance?
Zileuton is not classified as a controlled substance by the DEA.
What is the generic name for Zileuton?
The generic name for Zileuton is zileuton. There are 1 other brand versions of zileuton.
What is the NDC code for Zileuton 600 mg/1?
The NDC (National Drug Code) for Zileuton 600 mg/1 is 51407-741, listed by Golden State Medical Supply, Inc..