COLCRYS Dosing

INDICATIONS

COLCRYS is indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.

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

Dose modifications for the treatment of acute gout attacks in patients with renal or hepatic impairment1

  • Maximum recommended dose is 1.8 mg taken over a 1-hour period; higher doses have not been found to be more effective1

  • May be administered for treatment of gout flares during prophylaxis at doses not to exceed 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) 1 hour later. Wait 12 hours and then resume the prophylactic dose1

Clcr=creatinine clearance.

    Drug interactions1

  • Colchicine is a P‑gp and CYP3A4 substrate. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine given with P‑gp and strong CYP3A4 inhibitors. If treatment with a P‑gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, the patient's dose of colchicine may need to be reduced or interrupted. Use of COLCRYS in conjunction with P‑gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir) is contraindicated in patients with renal or hepatic impairment

Treatment of gout flares with COLCRYS is not recommended in patients with renal or hepatic impairment who are receiving COLCRYS for prophylaxis.1

The recommended dosage of COLCRYS depends on the patient’s age, renal function, hepatic function and use of coadministered drugs.1

See the Dosage and Administration section of the complete Prescribing Information for all dosing information, including adjustments and potential drug interactions.

Help reduce gout attack pain at 24 hours1,2

Taken at the first sign, COLCRYS reduced the pain of acute gout attacks.

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CKD=chronic kidney disease; ULT=urate-lowering therapy.

IMPORTANT SAFETY INFORMATION

  • COLCRYS is contraindicated in patients with renal or hepatic impairment who are currently prescribed P-gp inhibitors or strong inhibitors of CYP3A4. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors in patients with normal renal and hepatic function.

  • Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.

  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported in patients taking colchicine at therapeutic doses.

  • Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk.

  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.

  • The most common adverse reactions in clinical trials were diarrhea (23%) and pharyngolaryngeal pain (3%).

INDICATIONS

COLCRYS (colchicine, USP) 0.6 mg tablets are indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.

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

Please see the complete Prescribing Information and Medication Guide.

References:

  1. COLCRYS (colchicine, USP) prescribing information. Takeda Pharmaceuticals.

  2. Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: twenty-four–hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010;62(4):1060-1068.

Important Safety Information

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IMPORTANT SAFETY INFORMATION

  • COLCRYS is contraindicated in patients with renal or hepatic impairment who are currently prescribed P-gp inhibitors or strong inhibitors of CYP3A4. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors in patients with normal renal and hepatic function.

  • Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.

  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported in patients taking colchicine at therapeutic doses.

  • Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk.

  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.

  • The most common adverse reactions in clinical trials were diarrhea (23%) and pharyngolaryngeal pain (3%).

INDICATIONS

COLCRYS (colchicine, USP) 0.6 mg tablets are indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.

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

Please see the complete Prescribing Information and Medication Guide.