Uloric

What is Uloric?

Uloric (Febuxostat) is a xanthine oxidase (XO) inhibitor used for the chronic management of hyperuricemia in patients with gout.

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Febuxostat

Febuxostat molecule ball

What are the uses of this medicine?

• Uloric (Febuxostat) is a prescription medicine called a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels in adults with gout.

Limitations of Use:

• ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

How does this medicine work?

Febuxostat (fe bux' oh stat) is a nonpurine inhibitor of xanthine oxidase that shares no structural homology to allopurinol or to hypoxanthine. Therapy with febuxostat leads to lowering of serum uric acid levels within a few weeks, and chronic therapy has been shown to decrease uric acid levels into target levels of <6 mg/dL and to decrease acute gouty attacks.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take Azathioprine (Azasan®, Imuran®)
• take Mercaptopurine (Purinethol®)
• take Theophylline (Theo-24®, Elixophyllin®, Theochron®, Theolair®, Uniphyl®)

What drug interactions can this medicine cause?

• ULORIC is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.
• No data are available regarding the safety of ULORIC during cytotoxic chemotherapy.

Is this medicine FDA approved?

• Febuxostat was approved for medical use in the European Union in 2008 and in the United States in 2009.

How should this medicine be used?

Recommended dosage:

• 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.
• No dose adjustment is necessary when administering ULORIC to patients with mild to moderate renal or hepatic impairment.

Administration:

• Take ULORIC exactly as your healthcare provider tells you to take it.
• ULORIC can be taken with or without food.
• ULORIC can be taken with antacids.
• Your gout may flare up when you start taking ULORIC, do not stop taking your ULORIC even if you have a flare. Your healthcare provider may give you other medicines to help prevent your gout flares.
• Your healthcare provider may do certain tests while you take ULORIC.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet: 40 mg, 80 mg.

This medicine is available in fallowing brand namesː

• ULORIC

What side effects can this medication cause?

The most common side effects of this medicine include:

• liver problems
• nausea
• gout flares
• joint pain
• rash

This medicine may cause serious side effects, including:

• Heart problems

What special precautions should I follow?

• After initiation of ULORIC, an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.
• A higher rate of cardiovascular thromboembolic events was observed in patients treated with ULORIC than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.
• Transaminase elevations have been observed in ULORIC-treated patients. Monitor liver function tests periodically.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No overdose of ULORIC was reported in clinical studies.

Treatment of overdosage:

• Patients should be managed by symptomatic and supportive care should there be an overdose.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• ULORIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: febuxostat
• Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, magnesium stearate, and Opadry II, green

Who manufactures and distributes this medicine?

Distributed by Takeda Pharmaceuticals America, Inc. Deerfield, IL

• ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.

What should I know about storage and disposal of this medication?

• Store ULORIC between 59°F - 86°F (15°C - 30°C).
• Keep ULORIC out of the light.

• Dailymed label info on Uloric
• FDA Uloric

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