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Mitigare Generic Name & Formulations
Legal Class
Rx
General Description
Colchicine 0.6mg; caps.
Pharmacological Class
Antiinflammatory.
How Supplied
Caps—100, 1000
Manufacturer
Mitigare Indications
Indications
Prophylaxis of gout flares.
Limitations of Use
Not studied for acute treatment of gout flares during prophylaxis. Not for treating pain from other causes.
Mitigare Dosage and Administration
Adult
0.6mg once or twice daily; max 1.2mg/day.
Children
Not established.
Mitigare Contraindications
Contraindications
Renal or hepatic impairment with concomitant CYP3A4 and P-gp dual inhibitors (life-threatening toxicity possible). Concurrent renal and hepatic impairment.
Mitigare Boxed Warnings
Not Applicable
Mitigare Warnings/Precautions
Warnings/Precautions
Monitor for toxicity; if present, consider temporary interruption or discontinuation. Renal or hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.
Mitigare Pharmacokinetics
See Literature
Mitigare Interactions
Interactions
See Contraindications. Avoid concomitant CYP3A4 inhibitors (eg, clarithromycin, ketoconazole, grapefruit juice, erythromycin, verapamil) and/or P-gp inhibitors (eg, clarithromycin, ketoconazole, cyclosporine); if unavoidable, reduce daily dose or frequency, and monitor for colchicine toxicity. Concomitant statins, fibrates may potentiate myopathy and rhabdomyolysis.
Mitigare Adverse Reactions
Adverse Reactions
Diarrhea, nausea, vomiting, abdominal pain; blood dyscrasias, neuromuscular toxicity, rhabdomyolysis, overdosage (may be fatal).
Mitigare Clinical Trials
See Literature
Mitigare Note
Not Applicable
Mitigare Patient Counseling
See Literature
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