MITIGARE
Generic Name and Formulations:
Colchicine 0.6mg; caps.
Company:
West-Ward Pharmaceutical Corp.
Gout
Gout
 
Indications for MITIGARE:
Prophylaxis of gout flares.

Limitations Of use:
Not studied for acute treatment of gout flares during prophylaxis. Not for treating pain from other causes.

Adult:
0.6mg once or twice daily; max 1.2mg/day.

Children:
Not established.

Contraindications:
Renal or hepatic impairment with concomitant CYP3A4 and P-gp dual inhibitors (life-threatening toxicity possible). Concurrent renal and hepatic impairment.

Warnings/Precautions:
Monitor for toxicity; if present, consider temporary interruption or discontinuation. Renal or hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.

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 and monitor for colchicine toxicity. Concomitant statins, fibrates may potentiate myopathy and rhabdomyolysis.

Pharmacological Class:
Antiinflammatory (alkaloid).

Adverse Reactions:
Diarrhea, nausea, vomiting, abdominal pain; blood dyscrasias (myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia), neuromuscular toxicity, rhabdomyolysis, overdosage (may be fatal).

How Supplied:
Caps—100, 1000