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Claims for Patent: 8,093,298

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Claims for Patent: 8,093,298

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, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.
Inventor(s): Davis; Matthew W. (Erwinna, PA)
Assignee: Mutual Pharmaceutical Company, Inc. (Philadelphia, PA)
Application Number:13/110,087
Patent 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.
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