3 Things You Should Know About Generic Colchicine 0.6 mg Capsules, 2022 Update

By: | | Topics : About Gout, Colchicine, Mitigare,

stock image of man holding up three fingers

Gout is a common form of arthritis that affects more than nine million Americans.1 The root cause of the condition is excess uric acid in the bloodstream.1 When the uric acid level in the body remains high for a long time, it can cause urate crystals to form in a joint.2 These crystals can trigger sudden episodes of excruciating pain, redness and swelling known as gout flares or gout attacks.2 Colchicine is an important medication for adults with gout because it can help prevent these painful gout attacks.3 Read on to find out 3 things you should know about Generic Colchicine 0.6mg Capsules.

1) Take Colchicine with allopurinol to prevent gout flares

If you suffer with gout, your doctor may have prescribed a urate-lowering therapy (ULT) such as allopurinol to reduce the amount of uric acid in your bloodstream.4 Although ULT is a key component of gout management, many people experience flares when they first begin taking it.4 This is because the reduction in the uric acid in the bloodstream (due to the ULT) can disturb the urate crystals that have formed in a joint.4 When these crystals are disturbed, they can trigger a gout flare.4

To help prevent gout attacks in patients taking ULT, the American College of Rheumatology Guidelines for the Management of Gout recommend an anti-inflammatory medicine such as Colchicine.5 Colchicine is the active ingredient in a medication called Mitigare® (Colchicine) 0.6mg Capsules and in Generic Colchicine 0.6mg Capsules.3

2) Colchicine has been used for centuries to prevent gout attacks

Colchicine comes from a plant called Colchicum autumnale, or autumn crocus, which is a species of the lily family.6 There is evidence that Colchicine was used more than 2000 years ago in ancient Greece.7 (It was first used specifically for gout around 600 AD.7) In 2014, West-Ward Pharmaceuticals (now known as Hikma Pharmaceuticals USA Inc.) received FDA approval for Mitigare® (Colchicine) 0.6mg Capsules.

3) Color matters

Generic Colchicine 0.6mg Capsules and Mitigare® (Colchicine) 0.6mg Capsules are a distinctive two-tone blue color.3 This bright pop of color may help patients distinguish their colchicine therapy from other medications they take.8,9 This feature can be especially important for older patients who take multiple medications each day.8,9

Eligible patients may save on Generic Colchicine 0.6mg Capsules and Mitigare®

Since the launches of Mitigare® and Generic Colchicine 0.6mg Capsules in 2015, Hikma has been focused on helping more patients prevent painful gout flares by lowering the overall cost of Colchicine therapy.10 The True Blue Savings Program is another way Hikma helps qualified patients save money. With the True Blue Savings Card, eligible patients can receive Generic Colchicine 0.6mg Capsules or Mitigare® (Colchicine) 0.6mg Capsules for as little as $0 for the first 30 days and get $5 refills.* Visit Mitigare.com today to learn more about the True Blue Savings Program and download your True Blue Savings Card.

*For all eligible patients 18 years or older who are legal residents of the United States or Puerto Rico. First 30 days are as little as $0 only for eligible patients. Maximum savings of $65 on the first fill and $50 on refills. Please see complete Terms and Conditions available at Mitigare.com.

Mitigare® is a registered trademark of Hikma Pharmaceuticals USA Inc.

This post was first published on Jan. 24, 2018.

 

Gout Friendly Diet Cheat Sheet

Discover the benefits of a gout-friendly diet that may reduce your risk of future flares.
INFOGRAPHIC

 

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 Mitigare®.

Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® 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 Mitigare®.

The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting and abdominal pain.

Please see the full Prescribing Information and Medication Guide for Mitigare® for complete product details.

NOTE: This article was not written by a medical professional and is not intended to substitute for the guidance of a physician. These are not Hikma’s recommendations for gout flare prevention, but rather facts and data collected from various reliable medical sources. For a full list of resources and their attributing links, see below.

HK-1916v1

References

  1. Chen-Xu M, et al. Contemporary Prevalence of Gout and Hyperuricemia in the United States and Decadal Trends: The National Health and Nutrition Examination Survey, 2007-2016. Arthritis Rheumatol. 2019 Jun;71(6):991-999.
  2. McKenzie BJ, Wechalekar MD, Johnston RV, Schlesinger N, Buchbinder R. Colchicine for acute gout. Cochrane Database of Systemic Reviews 2021, Issue 8. Art. No.:CD006190.
  3. Mitigare® (Colchicine) 0.6mg Capsules [prescribing information]. Columbus, OH: West-Ward Columbus, Inc.; 2019.
  4. Aung T, Myung G, FitzGerald JD. Treatment approaches and adherence to urate-lowering therapy for patients with gout. Patient Prefer Adherence. 2017;11:795–800.
  5. Clinical Practice Guidelines. American College of Rheumatology website. 2020 American College of Rheumatology Guideline for the Management of Gout. Available at: https://www.rheumatology.org/Portals/0/Files/Gout-Guideline-Final-2020.pdf Accessed September 27, 2022.
  6. Dubchak N, Falasca G. New and improved strategies for the treatment of gout. Int J Nephrol Renovasc Dis. 2010;3:145-166.
  7. Nuki G and Simkin PA. A concise history of gout and hyperuricemia and their treatment. Arthritis Res Ther. 3006;8(Suppl 1):S1-S5.
  8. White Paper—What Is the Significance of the Color of a Pill. Wallcur, LLC website. http://www.wallcur.com/whitepaper-pill-color.aspx. Accessed September 27, 2022.
  9. Medicines and You: A Guide for Older Adults. US Food & Drug Administration website. Available at: https://www.fda.gov/drugs/resources-you-drugs/medicines- and-you-guide-older-adults. Accessed September 27, 2022.
  10. First Databank. AnalySource® website. Available at https://www.analysource.com/. Accessed September 27, 2022.

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • 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 Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® 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 Mitigare®.
  • The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

Indication

Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.

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

For Full Prescribing Information please CLICK HERE and for Medication Guide CLICK HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228

Read More...

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • 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.