Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics

Abstract

Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.

1 . A method of using colchicine for prophylactic treatment of gout flares in a human gout patient so as to reduce the occurrence of colchicine toxicity when said patient is receiving concomitant administration of clarithromycin or erythromycin, comprising:
 orally administering a second colchicine daily dosage amount for prophylactic treatment of gout flares to the human gout patient who is concomitantly receiving administration of clarithromycin or erythromycin, wherein the second colchicine daily dosage amount is a 75% reduction of a first colchicine daily dosage amount suitable for daily oral administration for the prophylactic treatment of gout flares in the absence of concomitant administration of clarithromycin or erythromycin, wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount.   
     
     
         2 . The method of  claim 1 , wherein the first colchicine daily dosage amount is 1.2 mg administered as two 0.6 mg doses per day, or the first colchicine daily dosage amount is 0.6 mg per day. 
     
     
         3 . The method of  claim 1 , wherein the patient is also receiving a daily administration of a urate-lowering treatment. 
     
     
         4 . The method of  claim 3 , wherein the urate lowering-treatment is allopurinol or febuxostat. 
     
     
         5 . A method of using colchicine for prophylactic treatment of gout flares in an adult human gout patient also being treated with a daily administration of a urate-lowering treatment so as to reduce the occurrence of colchicine toxicity when said patient is receiving concomitant administration of clarithromycin or erythromycin, comprising:
 administering a reduced colchicine daily dosage amount to the patient for prophylactic treatment of gout flares, wherein the reduced colchicine daily dosage amount is 50-75% of a manufacturers' recommended colchicine daily dosage amount for the prophylactic treatment of gout flares in the absence of concomitant clarithromycin or erythromycin administration, wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount.   
     
     
         6 . The method of  claim 5 , wherein manufacturers' recommended colchicine daily dosage amount for the prophylactic treatment of gout flares in the absence of concomitant clarithromycin or erythromycin administration is 1.2 mg/day or 0.6 mg/day. 
     
     
         7 . The method of  claim 5  wherein the urate-lowering treatment is allopurinol or febuxostat. 
     
     
         8 . A method of using colchicine to treat a gout flare in a human patient who is receiving concomitant administration of clarithromycin or erythromycin, comprising:
 determining a first colchicine dosage amount adapted for oral administration to the patient to treat a gout flare in the absence of concomitant administration of clarithromycin or erythromycin,   determining a second colchicine dosage amount that is a 50-75% reduction of the first colchicine dosage amount, and   orally administering the second colchicine dosage amount to the patient who is experiencing a gout flare and is concomitantly receiving administration of clarithromycin or erythromycin,   wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount, and not repeating colchicine administration for at least three days.   
     
     
         9 . The method of  claim 5 , wherein the first colchicine dosage amount is 1.8 mg/day.