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MITIGARE
Gout
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Drug Name:

MITIGARE Rx

Generic Name and Formulations:
Colchicine 0.6mg; caps.

Company:
West-Ward Pharmaceutical Corp.

Therapeutic Use:

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.

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

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