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Gloperba Generic Name & Formulations
Legal Class
Rx
General Description
Colchicine 0.6mg/5mL; oral soln.
Pharmacological Class
Antiinflammatory.
How Supplied
Oral soln—150mL
Manufacturer
Generic Availability
NO
Gloperba 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.
Gloperba Dosage and Administration
Adult
0.6mg (5mL) once or twice daily; max 1.2mg/day.
Children
Not established.
Gloperba Contraindications
Contraindications
Renal or hepatic impairment with concomitant CYP3A4 and P-gp dual inhibitors (life-threatening toxicity possible). Concurrent renal and hepatic impairment.
Gloperba Boxed Warnings
Not Applicable
Gloperba Warnings/Precautions
Warnings/Precautions
Monitor for toxicity; if present, consider temporary interruption or discontinuation. Renal or hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Gloperba Pharmacokinetics
See Literature
Gloperba 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 or fibrates may potentiate myopathy. Concomitant posaconazole: max Gloperba 0.24mg (2mL).
Gloperba Adverse Reactions
Adverse Reactions
Diarrhea, nausea, vomiting, abdominal pain; blood dyscrasias, neuromuscular toxicity, rhabdomyolysis, overdosage (may be fatal).
Gloperba Clinical Trials
See Literature
Gloperba Note
Not Applicable
Gloperba Patient Counseling
See Literature
