Uloric Information
Uloric (Febuxostat) Indications And Usage
Uloric (Febuxostat) is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
Uloric (Febuxostat) is not recommended for the treatment of asymptomatic hyperuricemia.
Uloric (Febuxostat) Dosage And Administration
For treatment of hyperuricemia in patients with gout, Uloric (Febuxostat) is recommended at 40 mg or 80 mg once daily.
The recommended starting dose of Uloric (Febuxostat) 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 (Febuxostat) 80 mg is recommended.
Uloric (Febuxostat) can be taken without regard to food or antacid use
No dose adjustment is necessary when administering Uloric (Febuxostat) in patients with mild to moderate renal impairment The recommended starting dose of Uloric (Febuxostat) 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 (Febuxostat) 80 mg is recommended.
No dose adjustment is necessary in patients with mild to moderate hepatic impairment .
Gout flares may occur after initiation of Uloric (Febuxostat) 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 (Febuxostat) . Prophylactic therapy may be beneficial for up to six months .
If a gout flare occurs during Uloric (Febuxostat) treatment, Uloric (Febuxostat) need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient .
Uloric (Febuxostat) Contraindications
Uloric (Febuxostat) is contraindicated in patients being treated with azathioprine or mercaptopurine .
Uloric (Febuxostat) Warnings And Precautions
After initiation of Uloric (Febuxostat) , an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits.
In order to prevent gout flares when Uloric (Febuxostat) is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended
Uloric (Febuxostat) Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 2757 subjects with hyperuricemia and gout were treated with Uloric (Febuxostat) 40 mg or 80 mg daily in clinical studies. For Uloric (Febuxostat) 40 mg, 559 patients were treated for ≥ 6 months. For Uloric (Febuxostat) 80 mg, 1377 subjects were treated for ≥ 6 months, 674 patients were treated for ≥ 1 year and 515 patients were treated for ≥ 2 years.
Adverse reactions have been identified during post approval use of Uloric (Febuxostat) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.
Uloric (Febuxostat) Drug Interactions
Uloric (Febuxostat) is an XO inhibitor. Based on a drug interaction study in healthy subjects, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans . Therefore, use with caution when co-administering Uloric (Febuxostat) with theophylline.
Drug interaction studies of Uloric (Febuxostat) with other drugs that are metabolized by XO (e.g., mercaptopurine and azathioprine) have not been conducted. Inhibition of XO by Uloric (Febuxostat) may cause increased plasma concentrations of these drugs leading to toxicity . Uloric (Febuxostat) is contraindicated in patients being treated with azathioprine or mercaptopurine
Uloric (Febuxostat) Use In Specific Populations
No dose adjustment is necessary in patients with mild or moderate renal impairment (Cl 30-89 mL per min). The recommended starting dose of Uloric (Febuxostat) 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 (Febuxostat) 80 mg is recommended.
There are insufficient data in patients with severe renal impairment (Cl less than 30 mL per min); therefore, caution should be exercised in these patients
Uloric (Febuxostat) Overdosage
Uloric (Febuxostat) was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of Uloric (Febuxostat) was reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.
Uloric (Febuxostat) Description
Uloric (Febuxostat) is a xanthine oxidase inhibitor. The active ingredient in Uloric (Febuxostat) is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is CHNOS.
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 (Febuxostat) 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 (Febuxostat) tablets are coated with Opadry II, green.
Uloric (Febuxostat) Clinical Studies
A serum uric acid level of less than 6 mg per dL is the goal of anti-hyperuricemic therapy and has been established as appropriate for the treatment of gout.
Uloric (Febuxostat) How Supplied/storage And Handling
Uloric (Febuxostat) 40 mg tablets are light green to green in color, round shaped, debossed with "TAP" on one side and "40" on the other side and supplied as:
Uloric (Febuxostat) 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:
Uloric (Febuxostat) Patient Counseling Information
Uloric (Febuxostat)
Uloric (Febuxostat)
Uloric (Febuxostat)
Uloric (Febuxostat)
