Drug Catalog - Product Detail
Febuxostat Tab 80 MG 30 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 27808-0207-01 | TRIS PHARMA | 30 | 80MG | NA |
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Description
11 DESCRIPTION Febuxostat tablets are xanthine oxidase inhibitor. The active ingredient in febuxostat tablets is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 325.38. The empirical formula is C 16 H 16 N 2 O 3 S. 1/2 H 2 O The chemical structure is: structure Febuxostat hemihydrate is a non-hygroscopic, white to off white crystalline powder that is freely soluble in dimethylformamide; soluble in tetrahydrofuran; sparingly soluble in acetone and ethanol. The melting range is 203°C to 208°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat hemihydrate, and are available in two dosage strengths; 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, colloidal silicon dioxide and magnesium stearate. Febuxostat tablets are coated with Opadry II, green. The components of Opadry II, green are D&C yellow #10 aluminium lake, FD&C blue #1/ brilliant blue FCF aluminum lake, FD&C blue #2/ Indigo Carmine AL, Macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide. febuxostat structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Febuxostat tablets 40 mg tablets are light green to green coloured, round, biconvex, film coated tablet debossed with "18" on one side and "I" on the other side and supplied as: NDC Number Size 27808-206-01 Bottle of 30 Tablets Febuxostat tablets 80 mg tablets are light green to green coloured, tear drop shaped, biconvex, film coated tablet debossed with "19" on one side and "I" on the other side and supplied as: NDC Number Size 27808-207-01 Bottle of 30 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 Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 ) For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use : Febuxostat tablets is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Limitations of Use : Febuxostat tablets is not recommended for the treatment of asymptomatic hyperuricemia.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Recommended febuxostat tablets dosage is 40 mg or 80 mg once daily. The recommended starting dose is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. ( 2.1 ) Can be administered without regard to food or antacid use. ( 2.1 ) Limit the dosage of febuxostat tablets to 40 mg once daily in patients with severe renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dose The recommended febuxostat tablets dosage is 40 mg or 80 mg once daily. The recommended starting dosage of febuxostat tablets is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended febuxostat tablets dosage is 80 mg once daily. Febuxostat tablets can be taken without regard to food or antacid use [see Clinical Pharmacology (12.3) ]. 2.2 Dosage Recommendations in Patients with Renal Impairment and Hepatic Impairment No dose adjustment is necessary when administering febuxostat tablets in patients with mild or moderate renal impairment. The recommended dosage of febuxostat tablets 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 febuxostat tablets therapy. 2.4 Recommended Prophylaxis for Gout Flares Gout flares may occur after initiation of febuxostat tablets 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 febuxostat tablets. Prophylactic therapy may be beneficial for up to six months [see Clinical Studies (14.1) ] . If a gout flare occurs during treatment, febuxostat tablets need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient [see Warnings and Precautions (5.2) ] .