Methods for concomitant administration of colchicine and macrolide antibiotics

• US 8,093,298 B2
• Filed: 05/18/2011
• Issued: 01/10/2012
• 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:
  US13/110,087
• Publication Number:
  US 20110213037A1
• Time in Patent Office: 237 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 the treatment of Familial Mediterranean Fever in a human adult or child >

12 years of age in need of treatment thereof, said method comprising;

orally administering a reduced colchicine dosage amount to the human adult or child >

12 years of age in need of treatment for Familial Mediterranean Fever who is concomitantly receiving administration of clarithromycin within 1 to 2 days of oral administration of colchicine, wherein the reduced colchicine dosage amount is reduced compared to a daily dosage amount to be administered in the absence of concomitant clarithromycin,

wherein the daily dosage amount to be administered in the absence of concomitant clarithromycin is a maximum of 2.4 mg per day, and

wherein the reduced colchicine dosage amount is a maximum of 0.6 mg per day.

2. A method of using colchicine for the treatment of Familial Mediterranean Fever in a human child aged >

6 to 12 years in need of treatment thereof, said method comprising;

orally administering a reduced colchicine dosage amount to the human child aged >

6 to 12 years in need of treatment for Familial Mediterranean Fever who is concomitantly receiving administration of clarithromycin within 1 to 2 days of oral administration of colchicine, wherein the reduced colchicine dosage amount is reduced compared to a daily dosage amount to be administered in the absence of concomitant clarithromycin,

wherein the daily dosage amount to be administered in the absence of concomitant clarithromycin is a maximum of 1.8 mg per day, and

wherein the reduced colchicine dosage amount is a maximum of 0.6 mg per day.

3. A method of using colchicine for the treatment of Familial Mediterranean Fever in a human child aged 4 to 6 years in need of treatment thereof, said method comprising:

orally administering a reduced colchicine dosage amount to the human child aged 4 to 6 years in need of treatment for Familial Mediterranean Fever who is concomitantly receiving administration of clarithromycin within 1 to 2 days of oral administration of colchicine, wherein the reduced colchicine dosage amount is reduced compared to a daily dosage amount to be administered in the absence of concomitant clarithromycin,

wherein the daily dosage amount to be administered in the absence of concomitant clarithromycin is a maximum of 1.8 mg per day, and

wherein the reduced colchicine dosage amount is a maximum of 0.6 mg per day.