Generic Name and Formulations:
Colchicinum 4X; per gram; 0.25mL per each pump depression; transdermal gel.
Indications for COLCIGEL:
Treatment and prophylaxis of acute gout flares.
One dose = 0.25mL/pump. Each application = 1–4 doses. Treatment: Apply 2–4 pumps (0.5mL–1mL) at first sign of gout flare, then 2–4 pumps (0.5mL–1mL) as needed up to every hour; max 16 pumps (4 applications) in a 24-hour period; may be given during prophylaxis at max 2 pumps at first sign of flare, then 2 pumps hourly up to 3 doses as needed. Wait 12 hours, then resume prophylactic dose. Prophylaxis: >16yrs: Apply 1–3 pumps (0.25mL–0.75mL) twice daily; max 6 pumps (1.5mL) in a 24-hour period. Dose modification in renal or hepatic impairment: see full labeling.
Traumatized skin. Secondary bacterial infection of affected area. Concomitant P-glycoprotein or strong CYP3A4 inhibitors (except fosamprenavir) in severe renal or hepatic impairment (life-threatening toxicity was reported with oral colchicine).
Avoid eyes. Discontinue if irritation, sensitivity, infection, or toxicity is suspected or occurs. Increased risk of neuromuscular toxicity in renal impairment or elderly patients. Renal or hepatic impairment. Undergoing dialysis (treatment): not recommended; (prophylaxis): monitor closely. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Concomitant P-glycoprotein and/or CYP3A4 inhibitors; monitor for colchicine toxicity. Concomitant statins, gemfibrozil, fibrates, and cyclosporine may potentiate myopathy.
Skin irritation at site of application; possible blood dyscrasias, overdosage (may be fatal).
Gel—30mL (2 X 15mL bottles)
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