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Uloric

"The U.S. Food and Drug Administration today approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

Gout occurs due to an excess of the b"...

Uloric

Uloric

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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].

Special Populations

No dose adjustment is necessary when administering ULORIC in patients with mild to moderate renal impairment [see Use in Specific Populations and CLINICAL PHARMACOLOGY]. 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.

No dose adjustment is necessary in patients with mild to moderate hepatic impairment [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

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.

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].

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].

HOW SUPPLIED

Dosage Forms And Strengths

  • 40 mg tablets, light green to green, round, debossed with “TAP” and “40”
  • 80 mg tablets, light green to green, teardrop shaped, debossed with “TAP” and “80”

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].

Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: November 2012

Last reviewed on RxList: 11/16/2012
This monograph has been modified to include the generic and brand name in many instances.

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