: Not recommended for patients with severe hepatic impairment. ( 8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 1/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Patients with Renal Impairment
2.3 Gout Flares
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Renal Events
5.2 Cardiovascular Events
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 CYP2C9 Inhibitors, CYP2C9 Poor Metabolizers, and CYP2C9 Inducers
7.2 CYP3A Substrates
7.3 Epoxide Hydrolase Inhibitors
7.4 Hormonal Contraceptives
7.5 Aspirin
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 Secondary Hyperuricemia
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Overview of Clinical Studies of ZURAMPIC
14.2 Add-on to Allopurinol in Inadequate Responders
14.3 Combination with Febuxostat in Tophaceous Gout
14.4 Gout Flares and Tophus Outcomes
14.5 Use in Patients with Renal Impairment
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
ZURAMPIC is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone [see CLINICAL STUDIES (14)].
1.1 Limitations of Use
ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia.
ZURAMPIC should not be used as monotherapy [see WARNINGS AND PRECAUTIONS (5.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
ZURAMPIC tablets are for oral use and should be co-administered with a xanthine oxidase inhibitor, including allopurinol or febuxostat.
ZURAMPIC is recommended at 200 mg once daily. This is also the maximum daily dose. ZURAMPIC should be taken by mouth, in the morning with food and water.
ZURAMPIC may be added when target serum uric acid levels are not achieved on the medically appropriate dose of the xanthine oxidase inhibitor alone.
Use of ZURAMPIC is not recommended for patients taking daily doses of allopurinol less than 300 mg (or less than 200 mg in patients with estimated creatinine clearance (eCLcr) less than 60 mL/min). Take ZURAMPIC at the same time as the morning dose of xanthine oxidase inhibitor. If treatment with the xanthine oxidase inhibitor is interrupted, ZURAMPIC should also be interrupted. Failure to follow these instructions may increase the risk of renal events [see WARNINGS AND PRECAUTIONS (5.1)].
Patients should be instructed to stay well hydrated (eg, 2 liters [68 oz] of liquid per day).
2.2 Patients with Renal Impairment
No dose adjustment is needed in patients with mild or moderate renal impairment (eCLcr of 45 mL/min or greater). ZURAMPIC should not be initiated in patients with an eCLcr less than 45 mL/min. Assessment of renal function is recommended prior to initiation of ZURAMPIC therapy and |
