METHODS FOR CONCOMITANT ADMINISTRATION OF COLCHICINE AND A SECOND ACTIVE AGENT

• US 20110046227A1
• Filed: 08/21/2009
• Published: 02/24/2011
• Est. Priority Date: 08/21/2009
• Status: Abandoned Application

• Current Assignee: Mutual Pharmaceutical Co Inc (Takeda Pharmaceutical Company Limited)
• Original Assignee: Mutual Pharmaceutical Co Inc (Takeda Pharmaceutical Company Limited)
• Inventors: Davis, Matthew
• Application Number:
  US12/545,120
• Publication Number:
  US 20110046227A1
• Time in Patent Office: Days
• 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 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients
• CPC Class Codes: A61P 19/06 Antigout agents, e.g. antihyperuricemic or uricosuric agents

Abstract

Methods for concomitant administration of colchicine together with one or more second active agents, e.g., atorvastatin, 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.

Claims

1. A method of treating a patient with colchicine, comprising

orally administering an adjusted daily dosage amount of colchicine to the patient who is receiving concomitant administration of a daily dose of atorvastatin, wherein the atorvastatin is administered to treat an atorvastatin-responsive condition,

wherein the adjusted daily dosage amount of colchicine is about 50% to 75% 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 atorvastatin, wherein concomitant administration of atorvastatin is administration either simultaneously with colchicine or within a time period during which the effects of the colchicine are still operative in the patient.

2. The method of claim 1, wherein treating with colchicine is treating chronic gout.

3. The method of claim 1, wherein treating with colchicine is treating for acute gout.

4. The method of claim 1, wherein treating with colchicine is treating familial Mediterranean fever.

5. The method of claim 3, wherein, the intended daily dosage amount is 1.8 mg/day and the adjusted daily dosage amount is 1.2 mg/day.

6. The method of claim 5, further comprising not repeating colchicine administration for at least three days.

7. The method of claim 2, wherein, the intended daily dosage amount is 1.2 mg/day and the adjusted daily dosage amount is 0.6 mg/day.

8. The method of claim 2, wherein, the intended daily dosage amount is 0.6 mg/day and the adjusted daily dosage amount is 0.6 mg every other day.

9. The method of claim 1, further comprising carefully monitoring the individual for potential toxicity.

10. The method of claim 3, wherein the intended daily dosage amount is 1.8 to 2.4 mg and the maximum adjusted daily dosage amount is 1.8 mg.

11. The method of claim 4, wherein the intended daily dosage amount is 1.2 to 2.4 mg and the maximum adjusted daily dosage amount is 0.6 mg.

12. The method of claim 4, 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.

13. The method of claim 4, wherein the intended daily dosage amount is 0.3 to 1.8 mg and the maximum adjusted daily dosage amount is 0.6 mg.