Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics

• US 20100137235A1
• Filed: 10/09/2009
• Published: 06/03/2010
• Est. Priority Date: 10/15/2008
• Status: Abandoned Application

• Current Assignee: Mutual Pharmaceutical Company (Takeda Pharmaceutical Company Limited)
• Original Assignee: Mutual Pharmaceutical Company (Takeda Pharmaceutical Company Limited)
• Inventors: Davis, Matthew W.
• Application Number:
  US12/576,355
• Publication Number:
  US 20100137235A1
• Time in Patent Office: Days
• US Class Current: 514/29
• 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 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.

9. The method of claim 5, wherein the first colchicine dosage amount is 1.8 mg/day.

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.