A helpful resource about
Generic Colchicine Capsules
Colchicine for Gout Flare Prevention
Colchicine for Gout Flare Prevention: Coming from a plant called Colchicum autumnale, or autumn crocus (a member of the lily family), plant extracts containing colchicine have been used to prevent gout flares for centuries.1 Colchicine was prescribed for gout flare prevention for many years before manufacturers were required to have formal approval from the U.S. Food and Drug Administration (FDA).2
Colchicine 0.6 mg Capsules: Authorized Generic Colchicine 0.6 mg Capsules is a medicine used to help prevent gout flares in adults.
In 2014, the FDA approved the first and only colchicine for gout flare prevention in the form of a capsule. The capsule is sold under the brand name Mitigare® (Colchicine) 0.6 mg Capsules and is also available as an Authorized Generic Colchicine 0.6 mg Capsule for the prevention of gout flares in adults.
Generic Colchicine Capsules can be taken as a therapeutically equivalent substitute for Mitigare®.3
Generics vs. Authorized Generics: To receive FDA approval, generic medications must have the same active ingredients, same safety, same effectiveness, same strength, same quality and same benefits as their name-brand counterparts. According to the FDA, the term “authorized generic” is used to describe an approved brand-name drug that is marketed without the brand name on its label.4 With the exception of the fact that it does not have the brand name on its label, the authorized generic is the same as the branded product.4
Gout Flare Prevention Therapy: Using colchicine may help reduce your risk of flares.5
In one study, 43 patients starting allopurinol were randomized to receive colchicine 0.6 mg or placebo for up to 6 months. Over the study period, the mean number of gout attacks in patients receiving colchicine plus allopurinol was 0.52, compared with 2.91 gout attacks among patients receiving placebo.5
The chart below shows that study patients who received preventative colchicine therapy had 82% fewer gout flares.5
Preventative colchicine therapy, in doses of 0.5 to 2.0 mg per day, was given for periods of not less than 2 to no more than 10 years (mean 5.4 years) to 208 gouty subjects selected for analysis because of a prior history of frequent and disabling attacks of acute gouty arthritis.6
The chart below shows how preventative colchicine therapy can also reduce the severity of gout attacks.6
Colchicine Coupon: Generic Colchicine 0.6 mg Capsules may be an affordable flare prevention option for your patients with gout. Qualifying patients may save even more with a colchicine coupon called the True Blue Savings Card.
Hikma Pharmaceuticals developed the True Blue Savings Card for Mitigare® (Colchicine) 0.6 mg Capsules and Authorized Generic Colchicine Capsules to help make effective gout flare prevention even more affordable for eligible adult patients.
3 Options to Save
With this colchicine coupon, called the True Blue Savings Card, eligible patients can receive Mitigare® or Generic Colchicine Capsules for as little as $0 for the first 30 days and $5 refills.*
Visit your doctor and ask for the True Blue Savings Card when you are prescribed Generic Colchicine 0.6 mg Capsules or Mitigare® (Colchicine) 0.6 mg Capsules.
Download your colchicine coupon now:
With this True Blue Savings Card, eligible patients 18 years or older who are legal residents of the United States or Puerto Rico can receive their first 30 days for as little as $0. Maximum savings of $65 on the first fill and $50 on refills. Dispenses for 60-day supply (up to a maximum of 120 capsules) and 90-day supply (up to a maximum of 180 capsules) are permissible within the terms of the program, up to a total of a 12-month supply. See complete Terms and Conditions.
Find out if you are eligible for True Blue Savings now.
If you are uninsured, underinsured or are not eligible for the True Blue Savings Card, you may be able to access discounts for Generic Colchicine Capsules or Mitigare® by using the Inside Rx pharmacy discount card. Inside Rx offers a discount option for eligible cash-paying patients. See if you are eligible and view average potential savings for Generic Colchicine Capsules or Mitigare® at InsideRx.com. The Inside Rx card is accepted at nearly 40,000 pharmacies nationwide. The card is not insurance, and there is no membership fee.
First 30 days for as little as $0*
Can be used on Authorized Generic Colchicine Capsules or Mitigare (Colchicine) 0.6 mg Capsules.
*For all eligible patients 18 years or older who are legal residents of the United States or Puerto Rico. First 30 days for as little as $0 only for eligible patients. Maximum savings of $65 on the first fill and $50 on refills. See complete Terms and Conditions.
Colchicine Capsule Coverage: Authorized Generic Colchicine 0.6 mg Capsules and its branded equivalent, Mitigare® (Colchicine) 0.6 mg Capsules, are covered by most major health plans†, including:
- United Health Group, Inc.
- Aetna, Inc.
- CVS Caremark Rx
- Express Scripts PBM
- Cigna Health Plans, Inc.
- CVS SilverScript
†Managed Markets Insight & Technology, LLC database and formulary status as of May 2019.
Colchicine Dosage: Colchicine is a medicine that can help reduce the frequency and severity of gout attacks.5,6 The appropriate colchicine dosage of capsules for the prevention of gout flares in adults is 0.6 mg, taken once or twice daily. The maximum dose is 1.2 mg per day. For most adult patients, Mitigare® (Colchicine) 0.6 mg Capsules are taken once or twice daily. Mitigare® should be taken exactly as directed.
Colchicine Identification: The distinctive two-tone blue capsules give Generic Colchicine Capsules and Mitigare® a pop of color to help you differentiate them from your other medications.7,8
- 80 percent of 150 pharmacists surveyed believed visual similarities in pills contributed to trouble identifying medications.7
- The FDA advises that older adults who take more than one medicine should be able to tell them apart by size, shape, color and form (tablet or capsule).8
- The distinctive two-tone blue capsules stand out from other medicines, making them easier to identify for people who take multiple daily medications.7
Colchicine Side Effects
Colchicine Side Effects: Colchicine is the active ingredient in Generic Colchicine 0.6 mg Capsules. In a 6-month study of patients with recurrent gout, colchicine 0.6 mg was well tolerated.5
The most common colchicine side effects were gastrointestinal symptoms, including diarrhea, nausea, vomiting and abdominal pain.
If you experience adverse reactions or discomfort, talk to your doctor immediately. Please see the Important Safety Information and Medication Guide for additional product safety information. This information does not replace talking with your doctor about your medical conditions and treatment before taking Generic Colchicine Capsules or Mitigare® (Colchicine) 0.6 mg Capsules.
Gout Glossary & Resources
Gout Glossary: Terms to Understand
Here are some of the terms often used to describe gout, gout flares and gout flare prevention.
Gout Talk: Prepare for Your Dr. Visit
This form will help you talk with your doctor about your gout flares and how they impact your life.
Patient Brochure: What You Need to Know
Review the patient brochure to find out more about preventing gout flares and Mitigare®.
Colchicine Coupon: Learn More and Download
The True Blue Savings Card is a Generic Colchicine coupon that can help qualified patients save on colchicine therapy.
- Dubchak N, Falasca G. New and improved strategies for the treatment of gout. Int J Nephrol Renovasc Dis. 2010;3:145-166.
- Kesselheim AS, et al. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Nov;30(11):1633–1638.
- U.S. Food & Drug Administration website. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: https://ww.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed February 15, 2018.
- US Food and Drug Administration website. FDA List of Authorized Generic Drugs. Available at: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm126389.htm. Accessed March 7, 2019.
- Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004 Dec;31(12):2429-2432.
- Yu TF, Gutman AB. Efficacy of colchicine prophylaxis in gout. Prevention of recurrent gouty arthritis over a mean period of five years in 208 gouty subjects. Ann Intern Med. 1961; 55:179-192.
- White Paper — What Is the Significance of the Color of a Pill. Wallcur, LLC website. Available at: http://www.wallcur.com/whitepaper-pill-color.aspx. Accessed November 30, 2016.
- US Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors. US Food and Drug Administration website. Available at: http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm331810.pdf. Published December 2012. Accessed May 22, 2015.
Important Safety Information for Generic Colchicine 0.6 mg Capsules
- Generic Colchicine 0.6 mg Capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Generic Colchicine 0.6 mg Capsules.
- Fatal overdoses have been reported with colchicine in adults and children. Keep Generic Colchicine 0.6 mg Capsules out of the reach of children.
- Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
- Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
- Drug interaction with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.
- Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of Generic Colchicine 0.6 mg Capsules.
- The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting and abdominal pain.
Generic Colchicine 0.6 mg Capsules are indicated for prophylaxis of gout flares in adults.
The safety and effectiveness of Generic Colchicine 0.6 mg Capsules for acute treatment of gout flares during prophylaxis has not been studied.
Generic Colchicine 0.6 mg Capsules are not an analgesic medication and should not be used to treat pain from other causes.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Manufactured by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724