Rx Item-Colcrys 0.6Mg Tab 100 By Takeda Pharma

COLCRYS- colchicine tablet, film coated
Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE

1.1 Gout Flares
COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.

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Prophylaxis of Gout Flares:
COLCRYS is indicated for prophylaxis of gout flares.
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Treatment of Gout Flares: COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2 Familial Mediterranean Fever (FMF)


COLCRYS (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).

2 DOSAGE AND ADMINISTRATION

The long-term use of colchicine is established for FMF and the prophylaxis of gout flares, but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for COLCRYS are different for each indication and must be individualized.

The recommended dosage of COLCRYS depends on the patient�s age, renal function, hepatic function and use of coadministered drugs [see Dose Modification for Coadministration of Interacting Drugs (2.4)].

COLCRYS tablets are administered orally without regard to meals.

COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.

2.1 Gout Flares
Prophylaxis of Gout Flares

The recommended dosage of COLCRYS for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.

An increase in gout flares may occur after initiation of uric acid-lowering therapy, including pegloticase, febuxostat and allopurinol, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. COLCRYS is recommended upon initiation of gout flare prophylaxis with uric acid-lowering therapy. Prophylactic therapy may be beneficial for at least the first six months of uric acid-lowering therapy.

RX ITEM-Colcrys 0.6Mg Tab 100 By Takeda
NDC 64764-0119-01 UPC/GTIN No.3-64764-11901-1 Mfg.Part No.11901

Colcrys 0.6Mg Tab 100 By Takeda Pharma
BRAND: COLCRYS NDC: 64764-0119-01,64764011901 UPC: 3-64764-11901-1,364764119011 Takeda Pharma USA

COLCHICINE ORAL TABLET 0.
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