Understanding Gout: A Glossary of Commonly Used Gout Terms

Here are some of the terms often used to describe gout, gout flares and gout prevention.   Commonly Used Gout Terms acute gouty arthritis—A condition where uric acid crystals form Read more...

3 Things You Should Know About Generic Colchicine 0.6 mg Capsules

Colchicine is a medicine used to help prevent gout flares in adults.1 Gout is a form of inflammatory arthritis that occurs when too much uric acid builds up in the Read more...

Consider Mitigare® (colchicine) 0.6 mg Capsules for Preventing Gout Flares in Adults

Gout is a type of inflammatory arthritis caused by a condition called hyperuricemia.1 Hyperuricemia happens when there is too much uric acid in the body.1 When hyperuricemia becomes severe, uric Read more...

What is Gout?

Gout is a painful form of inflammatory arthritis.1 Approximately 8.3 million Americans live with this disease.1 Gout usually appears first in the big toe, but can also affect the midfoot, Read more...

What Men Need to Know About Gout

Gout, a painful form of inflammatory arthritis, causes swelling and redness in the big toe and feet, as well as other body parts.1 Gout results from an overproduction by the body Read more...

What Happens to Your Body When You Have Gout?

A frequently asked question is: “What happens to your body when you have gout?” Gout is a type of arthritis. It is caused by the buildup of uric acid crystals Read more...

What You Need to Know After Being Diagnosed with Gout

The big toe often is where gout attacks first. Gout attacks also can occur in the heels, instep, ankles, knees, elbows, hips, thumbs, and fingers. Symptoms of gout include intense Read more...

Couples and Gout: What You Need to Know

Gout is a form of inflammatory arthritis. Unlike other types of arthritis, it’s caused by a build-up of uric acid in the body. This build-up of uric acid can lead to 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. 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 Pharmaceuticals Corp., Eatontown, NJ 07724

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.