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Colcigel Generic Name & Formulations
Legal Class
Rx
General Description
Colchicinum 4X; per gram; 0.25mL per each pump depression; transdermal gel.
Pharmacological Class
Antiinflammatory.
How Supplied
Gel—30mL (2 X 15mL bottles)
Manufacturer
Generic Availability
NO
Colcigel Indications
Indications
Treatment and prophylaxis of acute gout flares.
Colcigel Dosage and Administration
Adult
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
Not recommended.
Colcigel Contraindications
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 Boxed Warnings
Not Applicable
Colcigel Warnings/Precautions
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 Pharmacokinetics
See Literature
Colcigel Interactions
Interactions
See Contraindications. Concomitant P-glycoprotein and/or CYP3A4 inhibitors; monitor for colchicine toxicity. Concomitant statins, gemfibrozil, fibrates, and cyclosporine may potentiate myopathy.
Colcigel Adverse Reactions
Adverse Reactions
Skin irritation at site of application; possible blood dyscrasias, overdosage (may be fatal).
Colcigel Clinical Trials
See Literature
Colcigel Note
Not Applicable
Colcigel Patient Counseling
See Literature
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