1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Special Populations
2.3 Uric Acid Level
2.4 Gout Flares
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Gout Flare
5.2 Cardiovascular Events
5.3 Liver Enzyme Elevations
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Xanthine Oxidase Substrate Drugs
7.2 Cytotoxic Chemotherapy Drugs
7.3 In Vivo Drug Interaction Studies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
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
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Management of Hyperuricemia in Gout
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 General Information
17.2 FDA-Approved Patient Labeling
 

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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ULORIC® is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
For treatment of hyperuricemia in patients with gout, ULORIC is recommended at 40 mg or 80 mg once daily.

The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended.

ULORIC can be taken without regard to food or antacid use [see Clinical Pharmacology (12.3)].

2.2 Special Populations
No dose adjustment is necessary when administering ULORIC in patients with mild to moderate renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a sUA less than 6 mg per dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended.

No dose adjustment is necessary in patients with mild to moderate hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.3 Uric Acid Level
Testing for the target serum uric acid level of less than 6 mg per dL may be performed as early as 2 weeks after initiating ULORIC therapy.

2.4 Gout Flares
Gout flares may occur after initiation of ULORIC due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of ULORIC. Prophylactic therapy may be beneficial for up to six months [see Clinical Studies (14.1)].

If a gout flare occurs during ULORIC treatment, ULORIC need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS
40 mg tablets, light green to green, round shaped, debossed with "TAP" and &qu