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Colcrys

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Colcrys

Colcrys

INDICATIONS

Gout Flares

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

Prophylaxis of Gout Flares

COLCRYS is indicated for prophylaxis of gout flares.

Treatment of Gout Flares

COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.

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).

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 co-administered drugs [see Dose Modification for Co-administration of Interacting Drugs].

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.

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.

Treatment of Gout Flares

The recommended dose of COLCRYS for treatment of a gout flare is 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1 hour period. COLCRYS may be administered for treatment of a gout flare 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) one hour later. Wait 12 hours and then resume the prophylactic dose.

FMF

The recommended dosage of COLCRYS for FMF in adults is 1.2 mg to 2.4 mg daily.

COLCRYS should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily COLCRYS dose may be administered in one to two divided doses.

Recommended Pediatric Dosage

Prophylaxis and Treatment of Gout Flares

COLCRYS is not recommended for pediatric use in prophylaxis or treatment of gout flares.

FMF

The recommended dosage of COLCRYS for FMF in pediatric patients 4 years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily:

  • Children 4 – 6 years: 0.3 mg to 1.8 mg daily
  • Children 6 – 12 years: 0.9 mg to 1.8 mg daily
  • Adolescents older than 12 years: 1.2 mg to 2.4 mg daily

Dose Modification for Co-administration of Interacting Drugs

Concomitant Therapy

Co-administration of COLCRYS with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown on the table below [see DRUG INTERACTIONS].

Table 1 : COLCRYS Dose Adjustment for Co-administration with Interacting Drugs if no Alternative Available1

Strong CYP3A4 Inhibitors2 Gout Flares FMF
Drug Noted or Anticipated Outcome
Prophylaxis of Gout Flares Treatment of Gout Flares
Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose
Atazanavir Clarithromycin Darunavir/ Ritonavir3 Indinavir Itraconazole Ketoconazole Lopinavir/ Ritonavir3 Nefazodone Nelfinavir Ritonavir Saquinavir Telithromycin Tipranavir/ Ritonavir3 Significant increase in colchicine plasma levels1; fatal colchicine toxicity has been reported with clarithromycin, a strong CYP3A4 inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other strong CYP3A4 inhibitors. 0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
1.2 mg (2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 1.2 - 2.4 mg Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
Moderate CYP3A4 Inhibitors
Drug Noted or Anticipated Outcome Gout Flares FMF
Prophylaxis of Gout Flares Treatment of Gout Flares
Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose
Amprenavir3 Aprepitant Diltiazem Erythromycin Fluconazole Fosamprenavir3 (pro-drug of Amprenavir) Grapefruit Juice Verapamil Significant increase in colchicine plasma concentration is anticipated. Neuromuscular toxicity has been reported with diltiazem and verapamil interactions. 0.6 mg twice a day
0.6 mg once a day
0.3 mg twice a day or 0.6 mg once a day
0.3 mg once a day
1.2 mg (2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 1.2 mg (2 tablets) x 1 dose. Dose to be repeated no earlier than 3 days. Maximum daily dose of 1.2 - 2.4 mg. Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day)
P-gp Inhibitors2
Drug Noted or Anticipated Outcome GoutFlares FMF
Prophylaxis Original Intended Dosage of Gout Flares Adjusted Dose Treatment Original Intended Dosage of Gout Flares Adjusted Dose
Original Intended Dosage Adjusted Dose
Cyclosporine Ranolazine Significant increase in colchicine plasma levels1; fatal colchicine toxicity has been reported with cyclosporine, a P-gp inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other P-gp inhibitors. 0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
1.2 mg (2 tablets) followed by 0.6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 0.6 mg (1 tablet) x 1 dose. Dose to be repeated no earlier than 3 days. Maximum daily dose of 1.2 - 2.4 mg Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
1 For magnitude of effect on colchicine plasma concentrations [see Pharmacokinetics]
2 Patients with renal or hepatic impairment should not be given COLCRYS in conjunction with strong CYP3A4 or P-gp inhibitors [see CONTRAINDICATIONS].
3 When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [see CONTRAINDICATIONS].

Table 2 : COLCRYS Dose Adjustment for Co-administration with Protease Inhibitors

Protease Inhibitor Clinical Comment w/Colchicine – Prophylaxis of Gout Flares w/Colchicine – Treatment of Gout Flares w/Colchicine – Treatment of FMF
Atazanavir sulfate (Reyataz) Patients with renal or hepatic impairment should not be given colchicine with Reyataz. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Darunavir (Prezista) Patients with renal or hepatic impairment should not be given colchicine with Prezista/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Fosamprenavir (Lexiva) with Ritonavir Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Fosamprenavir (Lexiva) Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. Original dose Adjusted dose 1.2 mg (2 tablets) x 1 dose. Dose to be repeated no earlier than 3 days. Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg twice a day or 0.6 mg once a day
0.3 mg once a day
Indinavir (Crixivan) Patients with renal or hepatic impairment should not be given colchicine with Crixivan. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Lopinavir/Ritonavir (Kaletra) Patients with renal or hepatic impairment should not be given colchicine with Kaletra. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Nelfinavir mesylate (Viracept) Patients with renal or hepatic impairment should not be given colchicine with Viracept Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Ritonavir (Norvir) Patients with renal or hepatic impairment should not be given colchicine with Norvir. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Saquinavir mesylate (Invirase) Patients with renal or hepatic impairment should not be given colchicine with Invirase/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day
Tipranavir (Aptivus) Patients with renal or hepatic impairment should not be given colchicine with Aptivus/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day)
0.6 mg twice a day 0.6 mg once a day 0.3 mg once a day 0.3 mg once every other day

Treatment of gout flares with COLCRYS is not recommended in patients receiving prophylactic dose of COLCRYS and CYP3A4 inhibitors.

Dose Modification in Renal Impairment

Colchicine dosing must be individualized according to the patient's renal function [see Renal Impairment].

Clcr in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following formula:

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)

Gout Flares

Prophylaxis of Gout Flares

For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see CLINICAL PHARMACOLOGY and Renal Impairment].

Treatment of Gout Flares

For treatment of gout flares in patients with mild (Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every 2 weeks. For patients with gout flares requiring repeated courses consideration should be given to alternate therapy. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (1 tablet). For these patients, the treatment course should not be repeated more than once every 2 weeks [see CLINICAL PHARMACOLOGY and Renal Impairment].

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

FMF

Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing dialysis. For these patients, the dosage should be reduced [see CLINICAL PHARMACOLOGY]. Patients with mild (Clcr 50 – 80 mL/min) and moderate (Clcr 30 – 50 mL/min) renal impairment should be monitored closely for adverse effects of COLCRYS. Dose reduction may be necessary. For patients with severe renal failure (Clcr less than 30 mL/minute), start with 0.3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Renal Impairment]. For patients undergoing dialysis, the total recommended starting dose should be 0.3 mg (half tablet) per day. Dosing can be increased with close monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see CLINICAL PHARMACOLOGY and Renal Impairment].

Dose Modification in Hepatic Impairment

Gout Flares

Prophylaxis of Gout Flares

For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Hepatic Impairment].

Treatment of Gout Flares

For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, for the treatment of gout flares in patients with severe impairment while the dose does not need to be adjusted, but a treatment course should be repeated no more than once every 2 weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Hepatic Impairment].

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

FMF

Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of colchicine. Dose reduction should be considered in patients with severe hepatic impairment [see Hepatic Impairment].

HOW SUPPLIED

Dosage Forms And Strengths

0.6 mg tablets — purple capsule-shaped, film-coated with AR 374 debossed on one side and scored on the other side.

Storage And Handling

COLCRYS® (colchicine, USP) tablets 0.6 mg, are purple, film-coated, capsule-shaped tablets, debossed with ‘AR 374' on one side and scored on the other side.

Bottles of 30 NDC 13310-119-07
Bottles of 60 NDC 13310-119-06
Bottles of 100 NDC 13310-119-01
Bottles of 250 NDC 13310-119-03
Bottles of 500 NDC 13310-119-05
Bottles of 1000 NDC 13310-119-10

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Protect from light.

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured for: AR Scientific Inc., Philadelphia, PA 19124 USA by: Mutual Pharmaceutical Company, Inc. Philadelphia, PA 19124 USA. Rev 10, July 2011

Last reviewed on RxList: 8/5/2011
This monograph has been modified to include the generic and brand name in many instances.

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