FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
MITIGARE™ (colchicine) capsules are indicated for prophylaxis of gout flares in adults.
Limitations of use: 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.
History
There is currently no drug history available for this drug.
Other Information
Colchicine is an alkaloid obtained from the plant colchicum autumnale.
The chemical name for colchicine is (S)-N-(5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. The structural formula is represented below:
Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether.
MITIGARE™ (colchicine) capsules are supplied for oral administration. Each capsule contains 0.6 mg Colchicine and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF and Quinoline Yellow.
Sources
Mitigare Manufacturers
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Hikma Americas, Inc.
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