Gout:
Indications for: COLCIGEL
Treatment and prophylaxis of acute gout flares.
Adult Dosage:
One dose (0.25mL–1mL) = 1–4 pumps. Treatment: Apply 1–4 pumps (0.25mL–1mL) at first sign of gout flare, then 1–4 pumps (0.25mL–1mL) as needed up to every hour; max 6 pumps (1.5mL) in a 1-hour period and 16 pumps (4 doses) 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.
Children Dosage:
Not recommended.
COLCIGEL Contraindications:
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).
COLCIGEL Warnings/Precautions:
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.
COLCIGEL Classification:
Antiinflammatory.
COLCIGEL Interactions:
See Contraindications. Concomitant P-glycoprotein and/or CYP3A4 inhibitors; monitor for colchicine toxicity. Concomitant statins, gemfibrozil, fibrates, and cyclosporine may potentiate myopathy.
Adverse Reactions:
Skin irritation at site of application; possible blood dyscrasias, overdosage (may be fatal).
Generic Drug Availability:
NO
How Supplied:
Gel—30mL (2 X 15mL bottles)
