Drug Catalog - Product Detail
ULORIC TABLET 80MG 30 X 1
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64764-0677-30 | TAKEDA PHARMACEUTICALS | 30 | 80MG | TABLET |
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Description
11 DESCRIPTION ULORIC (febuxostat) is a xanthine oxidase inhibitor. The active ingredient in ULORIC is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C 16 H 16 N 2 O 3 S. The chemical structure is: Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205°C to 208°C. ULORIC tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide and magnesium stearate. ULORIC tablets are coated with Opadry II, green. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING ULORIC 40 mg tablets are light green to green in color, round, debossed with "TAP" on one side and "40" on the other side and supplied as: NDC Number Size 64764-918-11 Hospital Unit Dose Pack of 100 Tablets 64764-918-30 Bottle of 30 Tablets 64764-918-90 Bottle of 90 Tablets 64764-918-18 Bottle of 500 Tablets ULORIC 80 mg tablets are light green to green in color, teardrop shaped, debossed with "TAP" on one side and "80" on the other side and supplied as: NDC Number Size 64764-677-11 Hospital Unit Dose Pack of 100 Tablets 64764-677-30 Bottle of 30 Tablets 64764-677-13 Bottle of 100 Tablets 64764-677-19 Bottle of 1000 Tablets Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Indications & Usage
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. ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ( 1 ) ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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/dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended. ( 2.1 ) ULORIC can be administered without regard to food or antacid use. ( 2.1 ) Limit the dose of ULORIC to 40 mg once daily in patients with severe renal impairment. ( 2.2 , 8.6 ) 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/dL after two 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 or moderate renal impairment. The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a sUA less than 6 mg/dL after two weeks with 40 mg, ULORIC 80 mg is recommended. The dose of ULORIC is limited to 40 mg once daily in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 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/dL may be performed as early as two 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) ] .