Methods for concomitant administration of colchicine and macrolide antibiotics

• US 8,097,655 B2
• Filed: 05/17/2011
• Issued: 01/17/2012
• Est. Priority Date: 10/15/2008
• Status: Active Grant

• Current Assignee: Takeda Pharmaceuticals USA Incorporated (Takeda Pharmaceutical Company Limited)
• Original Assignee: Mutual Pharmaceutical Company (Takeda Pharmaceutical Company Limited)
• Inventors: Davis, Matthew W.
• Primary Examiner(s): Padmanabhan, Sreeni
• Assistant Examiner(s): MCMILLIAN, KARA RENITA
• Application Number:
  US13/109,034
• Publication Number:
  US 20110207825A1
• Time in Patent Office: 245 Days
• Field of Search: 514/629, 564/123, 564/308, 564/427, 568/306
• US Class Current: 514/629
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/06 Antigout agents, e.g. antihyperuricemic or uricosuric agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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.

Claims

1. A method of using colchicine for prophylactic treatment of gout flares in an adult human gout patient so as to reduce the occurrence of colchicine toxicity when said patient is receiving concomitant administration of clarithromycin, said method comprising:

orally administering a reduced colchicine daily dosage amount to the patient for prophylactic treatment of gout flares, wherein the reduced colchicine daily dosage amount is a 75% reduction of a colchicine dosage amount adapted for oral administration to the gout patient for the prophylaxis of gout flares in the absence of concomitant administration of clarithromycin,

wherein concomitant administration of clarithromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount.

2. The method of claim 1, wherein the colchicine dosage amount adapted for oral administration to the gout patient for the prophylaxis of gout flares in the absence of concomitant administration of clarithromycin is 0.6 mg twice per day.

3. The method of claim 2, wherein the reduced colchicine dosage amount is 0.3 mg once per day.

4. The method of claim 1, wherein the colchicine dosage amount adapted for oral administration to the gout patient for the prophylaxis of gout flares in the absence of concomitant administration of clarithromycin is 0.6 mg once per day.

5. The method of claim 4, wherein the reduced colchicine dosage amount is 0.3 mg once every other day.