There have been post-marketing reports of Colchicine toxicity with concomitant use of Clarithromycin ( Biaxin/Klacid ) and Colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.

Colchicine is used to prevent or treat attacks of gout, and Clarithromycin is macrolide antibiotic, effective against a wide variety of bacteria organisms, such as Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Staphylococcus aureus, and Mycobacterium avium.

Precautions/Drug Interactions

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein ( Pgp ). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp.
When Clarithromycin and Colchicine are administered together, inhibition of Pgp and/or CYP3A by Clarithromycin may lead to increased exposure to Colchicine.
Patients should be monitored for clinical symptoms of Colchicine toxicity.

Precautions/Geriatric Use

In a steady-state study in which healthy elderly subjects ( age 65 to 81 years old ) were given 500 mg every 12 hours, the maximum serum concentrations and area under the curves of Clarithromycin and 14-OH Clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function.
In clinical trials, elderly patients did not have an increased incidence of adverse events when compared to younger patients. Dosage adjustment should be considered in elderly patients with severe renal impairment.

Source: FDA, 2006


XagenaMedicine2006