Methods for Concomitant Administration of Colchicine and a Second Active Agent

Abstract

Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.

1 . A method of treating a patient with colchicine, comprising
 administering an adjusted daily dosage amount of colchicine to the patient who is receiving concomitant administration of a recommended daily dosage amount of ritonavir,   wherein the adjusted daily dosage amount of colchicine is 25% to 50% of an intended daily dosage amount of colchicine, and   wherein the intended daily dosage amount of colchicine is a daily dosage amount suitable for the patient if the patient were not receiving concomitant ritonavir.   
     
     
         2 . The method of  claim 1 , wherein treating is to prevent gout flares. 
     
     
         3 . The method of  claim 1 , wherein treating is for acute gout. 
     
     
         4 . The method of  claim 1 , wherein treating is treating familial Mediterranean fever. 
     
     
         5 . The method of  claim 1 , wherein the colchicine is administered to prevent gout flares, and wherein the adjusted daily dosage amount of colchicine is reduced from a 0.6 mg twice daily intended dose to a 0.6 mg once daily adjusted dose. 
     
     
         6 . The method of  claim 1 , wherein the colchicine is administered to prevent gout flares, wherein the adjusted daily dosage amount of colchicine is reduced from a 0.6 mg once daily intended dose to a 0.3 mg once daily adjusted dose. 
     
     
         7 . The method of  claim 1 , wherein the recommended daily dosage amount of ritonavir is 200 or 1200 mg per day. 
     
     
         8 . The method of  claim 1 , wherein the ritonavir is administered to the patient before the colchicine is administered to the patient, and wherein the administration of ritonavir is terminated no more than about fourteen days prior to the initiation of colchicine administration. 
     
     
         9 . The method of  claim 1 , wherein treating is to prevent gout flares and the adjusted daily dosage amount of colchicine is 0.6 mg. 
     
     
         10 . The method of  claim 1 , wherein treating is to prevent gout flares and the adjusted daily dosage amount of colchicine is 0.3 mg. 
     
     
         11 . The method of  claim 1 , further comprising carefully monitoring the individual for potential toxicity. 
     
     
         12 . The method of  claim 1 , wherein treating is for acute gout, the intended daily dosage amount is 1.8 to 2.4 mg and the maximum adjusted daily dosage amount is 0.6 mg. 
     
     
         13 . The method of  claim 1 , wherein treating is for familial Mediterranean fever, the intended daily dosage amount is 1.2 to 2.4 mg and the maximum adjusted daily dosage amount is 0.6 mg. 
     
     
         14 . The method of  claim 1 , wherein treating is for familial Mediterranean fever, the intended daily dosage amount is 0.9 to 1.8 mg and the maximum adjusted daily dosage amount is 0.6 mg. 
     
     
         15 . The method of  claim 1 , wherein treating is for acute gout, the intended daily dosage amount is 2.4 to 4.8 mg and the maximum adjusted daily dosage amount is 0.6 to 1.2 mg.