Data from FDA - Curated by EPG Health - Last updated 30 August 2017

Indication(s)

1 INDICATIONS AND USAGE ColciGel® (colchicinum 4X) transdermal gel is an alkaloid indicated for: Treatment and Prophylaxis of Gout Flares in adults.(1.1) ColciGel® (colchicinum 4X) is not an analgesic medication and should not be used to treat pain from other causes. 1.1 Gout Flares ColciGel® transdermal gel is indicated for prophylaxis and the treatment of acute gout flares. Treatment of Gout Flares: ColciGel® gel is indicated for treatment of acute gout flares when used at the first sign of a flare. Prophylaxis of Gout Flares: ColciGel® is indicated for prophylaxis of gout flares.

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Advisory information

contraindications
4 CONTRAINDICATIONS Traumatized skin, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. Patients with severe renal or severe hepatic impairment should not be given ColciGel® in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors, except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with ORAL colchicine taken in therapeutic doses.
Special warnings and precautions
PRECAUTIONS Use in Pregnancy: No human or animal studies on the effect of ColciGel® (colchicinum 4X) in pregnancy have been conducted. Nursing Mothers: It is not known whether ColciGel® (colchicinum 4X) is excreted in breast milk.
Adverse reactions
6 ADVERSE REACTIONS Prophylaxis and Treatment of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis and treatment of gout was mild skin irritation at the site of application.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Apply 1 – 4 pumps up to four times per day. 1 application = 1 pump (0.25ml) covers an area 4” in diameter. Children under 16 years of age do not use unless directed by a physician. DISCARD 6 MONTHS AFTER FIRST USE

Interactions

7 DRUG INTERACTIONS ColciGel® (Colchicinum 4X) is a substrate of the efflux transporter P-glycoprotein (P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicinum. If ORAL colchicine is administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicinum are likely. Fatal drug interactions have been reported. Topical application of ColciGel® has demonstrated insignificant systemic absorption in animal testing and confirmed in limited human pharmacokinetic evaluations and, therefore, poses a limited risk of clinically significant drug interactions. Physicians should, however, ensure that patients are suitable candidates for treatment with ColciGel® and remain alert for signs and symptoms of toxicities related to increased colchicinum exposure as a result of a drug interaction. Signs and symptoms of ColciGel® toxicity should be evaluated promptly and, if toxicity is suspected, ColciGel® should be discontinued immediately.

More information

Category Value
Agency product number SML2Y3J35T
Orphan designation No
Product NDC 35781-0400
Date Last Revised 01-05-2015
Type HUMAN PRESCRIPTION DRUG
Storage and handling 14.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN ORIGINAL CONTAINER.
Marketing authorisation holder Gensco Laboratories, LLC