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Claims for Patent: 7,619,004

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Claims for Patent: 7,619,004

Title:Methods for concomitant administration of colchicine and macrolide antibiotics
Abstract:Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin or erythromycin, 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 co-administration of colchicine together with macrolide antibiotics are also provided.
Inventor(s): Davis; Matthew W. (Erwinna, PA)
Assignee: Mutual Pharmaceutical Company, Inc. (Philadelphia, PA)
Application Number:12/327,258
Patent 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, said method 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, 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, wherein concomitant administration of clarithromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount, and wherein the first colchicine daily dosage amount is 1.2 mg administered as two 0.6 mg doses per day, and the second colchicine daily dosage amount is 0.3 mg per day, or wherein the first colchicine daily dosage amount is 0.6 mg per day and the second colchicine daily dosage amount is 0.15 mg per day administered as 0.3 mg every other day, or wherein the first colchicine daily dosage amount is 0.6 mg per day and the second colchicine daily dosage amount is 0.15 mg per day.

2. The method of claim 1 wherein the patient is administered each dose of colchicine as one 0.6 mg colchicine tablet or as one half of a 0.6 mg colchicine tablet.

3. The method of claim 1 wherein the patient is an adult.

4. The method of claim 3 wherein the patient is less than 70 years old.

5. 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: administering a reduced colchicine daily dosage amount to the patient for prophylactic treatment of gout flares, wherein the reduced colchicine daily dosage amount is 75% of a manufacturers' recommended colchicine daily dosage amount for the prophylactic treatment of gout flares in the absence of concomitant clarithromycin administration, wherein concomitant administration of clarithromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount.

6. The method of claim 5 wherein the reduced colchicine daily dosage amount is about 0.3 mg per day.

7. The method of claim 5 wherein the reduced colchicine daily dosage amount is about 0.15 mg per day, which is administered as 0.3 mg of colchicine once a day every other day.

8. The method of claim 1 wherein the clarithromycin is administered concurrently with the second colchicine daily dosage amount.
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