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Claims for Patent: 8,093,297

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Claims for Patent: 8,093,297

Title:Methods for concomitant administration of colchicine and a second active agent
Abstract: Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, 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.
Inventor(s): Davis; Matthew W. (Erwinna, PA)
Assignee: Mutual Pharmaceutical Company, Inc. (Philadelphia, PA)
Application Number:13/092,459
Patent Claims: 1. A method of treating a patient in need of treatment for gout or familial Mediterranean fever with colchicine, comprising orally administering an adjusted daily dosage amount of colchicine to the patient who is receiving concomitant administration of a recommended daily dosage amount of ritonavir, wherein the adjusted daily dosage amount of colchicine is 25% to 50% of a daily dosage amount of colchicine suitable for the patient if the patient were not receiving concomitant ritonavir.

2. The method of claim 1, wherein treating with colchicine is for the prophylaxis of gout flares, and wherein the daily dosage amount of colchicine suitable for the patient if the patient were not receiving concomitant ritonavir is 0.6 mg twice daily or 0.6 mg once daily.

3. The method of claim 2 wherein the adjusted daily dosage amount of colchicine is 0.3 mg once daily.

4. The method of claim 2, wherein the adjusted daily dosage amount of colchicine is 0.3 mg once every other day.

5. The method of claim 1, wherein treating with colchicine is for the treatment of gout flares, and wherein the daily dosage amount of colchicine suitable for the patient if the patient were not receiving concomitant ritonavir is 1.2 mg at the first sign of flare, followed by 0.6 mg one hour later, dose to be repeated no earlier than 3 days.

6. The method of claim 5, wherein the adjusted daily dosage amount is 0.6 mg at the first sign of a flare, followed by 0.3 mg one hour later, dose to be repeated no earlier than 3 days.

7. The method of claim 1, wherein treating with colchicine is for treatment of familial Mediterranean fever, and wherein the adjusted daily dosage amount of colchicine is a maximum colchicine dosage amount of 0.3 mg of colchicine twice daily, which is a reduction from the intended daily dosage amount of colchicine in the absence of concomitant ritonavir wherein the intended daily dosage amount is a maximum daily dosage amount as follows: TABLE-US-00021 Daily dosage amount Age Usual Maximum Adults and children > 12 years 1.2 mg 2.4 mg Children > 6 to 12 years 0.9 mg 1.8 mg Children 4 to 6 years 0.3 mg .sup. 1.8 mg.

8. The method of claim 1, wherein the recommended daily dosage amount of ritonavir is 200 mg to 1200 mg per day.

9. The method of claim 1, wherein the recommended daily dosage amount of ritonavir is 200 mg or 1200 mg per day.
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