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Colcrys (Colchicine) - Summary

 
 



COLCRYS SUMMARY

COLCRYS® tablets cotain alkaloid colchicine.

COLCRYS® (colchicine, USP) is indicated for the following:

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).


See all Colcrys indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Colcrys (Colchicine)

Preventing Gout Flare Ups In Patients With Renal Impairment - Dosing Guidance
Source: Gout News From Medical News Today [2011.11.09]
Results from a new pharmacokinetic (PK) study presented at the annual meeting of the American College of Rheumatology (ACR) provide new evidence-based guidance for healthcare providers on using colchicine for gout flare prophylaxis in the presence of renal impairment...

In Gout Flare-Ups, The Big Toe Isn't The Biggest Culprit - Other Joints Tied To Higher Risk
Source: Arthritis / Rheumatology News From Medical News Today [2013.06.13]
The painful rheumatic condition gout is often associated with the big toe, but it turns out that patients at highest risk of further flare-ups are those whose gout first involved other joints, such as a knee or elbow, Mayo Clinic has found. The study is among several that Mayo researchers are presenting in Madrid at the European League Against Rheumatism's annual meeting...

Will New Gout Findings Get a Toehold?
Source: MedicineNet Arthritis Specialty [2013.06.12]
Title: Will New Gout Findings Get a Toehold?
Category: Health News
Created: 6/12/2013 10:35:00 AM
Last Editorial Review: 6/12/2013 12:00:00 AM

Vitamin C Does Not Lower Uric Acid Levels In Gout Patients
Source: Gout News From Medical News Today [2013.05.16]
Despite previous studies touting its benefit in moderating gout risk, new research reveals that vitamin C, also known ascorbic acid, does not reduce uric acid (urate) levels to a clinically significant degree in patients with established gout...

UL Medical School Researchers Find Increased Death Risk In Patients Suffering From Gout And Elevated Uric Acid Levels
Source: Gout News From Medical News Today [2013.05.02]
A new study led by researchers at the Graduate Entry Medical School (GEMS), University of Limerick (UL) has found that people suffering from gout and elevated serum uric acid have significantly increased risks of death. In their study, individuals with a diagnosis of gout experienced a 42 % higher risk of death from all causes and a 58% higher risk of cardiovascular death...

more news >>

Published Studies Related to Colcrys (Colchicine)

Colchicine treatment for recurrent pericarditis (CORP): a randomized trial. [2011.10.04]
BACKGROUND: Recurrence is the most common complication of pericarditis,affecting 10% to 50% of patients. OBJECTIVE: To evaluate the efficacy and safety of colchicine for the secondary prevention of recurrent pericarditis... CONCLUSION: Colchicine is safe and effective for secondary prevention of recurrent pericarditis.

Effect of colchicine compared with placebo on high sensitivity C-reactive protein in patients with acute coronary syndrome or acute stroke: a pilot randomized controlled trial. [2011.09.15]
There is a need for more effective therapies to reduce morbidity and mortality from cardiovascular disease. Inflammation plays a central role in the pathogenesis of atherosclerosis but no randomized studies have evaluated anti-inflammatory therapy in patients with acute coronary or cerebrovascular disease...

Colchicine prevents early postoperative pericardial and pleural effusions. [2011.09]
BACKGROUND: No preventive pharmacologic strategies have been proven efficacious for the prevention of postoperative effusions after cardiac surgery. Colchicine is safe and efficacious for the prevention of pericarditis. On this basis, we realized a substudy of the COPPS trial to assess the efficacy and safety of colchicine for the prevention of postoperative pericardial and pleural effusions... CONCLUSIONS: Colchicine is safe and efficacious for the primary prevention of postoperative effusions after cardiac surgery. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. [2011.09]
BACKGROUND & AIMS: The combination of ursodeoxycholic acid (UDCA), colchicine, and methotrexate (MTX) is effective therapy for a subset of patients with primary biliary cirrhosis (PBC) who do not respond to UDCA. However, the durability of the response is unclear. We investigated whether the response to combination therapy was durable... CONCLUSIONS: Treatment with the combination of UDCA and MTX or UDCA and colchicine led to sustained clinical remission in a subset of patients with PBC. The response to the combination of UDCA and MTX appeared to be more durable than to UDCA and colchicine. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

A double-blind randomized controlled trial appraising the symptom-modifying effects of colchicine on osteoarthritis of the knee. [2011.05]
OBJECTIVES: Osteoarthritis (OA) is the most common articular disease. Common OA treatments are either not effective or associated with side effects. Calcium-containing crystals are quite common in primary OA and they worsen or may cause OA through induction of inflammation by neutrophils. Colchicine inhibits urate-crystal and calcium-pyrophosphate (CPP) crystal induced inflammation and elastase, a matrix-metalloproteinase (MMP) that play a pivotal role in degenerative joint processes. Hence, it was hypothesized that it may have symptom-modifying effects on OA... CONCLUSIONS: The efficacy and safety of colchicine for pain reduction in OA was affirmed by our double-blind randomised controlled trial.

more studies >>

Clinical Trials Related to Colcrys (Colchicine)

Healthy and Renal Impairment Study of Colcrys (Colchicine, USP) [Recruiting]
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0. 6 mg oral dose of colchicine in healthy subjects with normal renal function and in subjects with mild, moderate or severe renal impairment, and subjects with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population.

Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients [Recruiting]
Ciclosporin inhibits P-glycoprotein should increase colchicine bioavailability whereas tacrolimus should not influence colchicine disposition.

This is a prospective, controlled, open labeled study performed in renal graft recipients comparing colchicine single dose (1mg) pharmacokinetics in 14 patients treated with tacrolimus and 14 patients treated with cyclosporin.

Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation and Post AF Ablation [Not yet recruiting]
Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Oral Colchicine in Men With Castrate Resistant Prostate Cancer [Not yet recruiting]
The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.

Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) [Recruiting]

A study designed to evaluate the role of treatment with a biological agent - Canakinumab in

pediatric (age 4-20) FMF patients that are intolerant or resistant for colchicine treatment.

The study hypothesis is that Canakinumab will reduce attack frequency and severity.

more trials >>

Reports of Suspected Colcrys (Colchicine) Side Effects

Diarrhoea (82)Drug Ineffective (62)Nausea (22)Hypoaesthesia (20)Dizziness (18)Paraesthesia (18)OFF Label USE (16)Abdominal Pain Upper (14)Rash (12)Insomnia (12)more >>


Page last updated: 2013-06-13

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