COLCHICINE PRODUCTS, METHOD OF MANUFACTURE, AND METHODS OF USE
First Claim
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1. A method of determining risk of an adverse event in administration of colchicine comprisingdetermining for a patient to whom colchicine is going to be administered or is being administered whether a substance that is currently being or will be administered to the patient is a substrate of CYP1A2;
- anddetermining risk for the patient of an adverse event during coadministration of colchicine and the substance resulting from reduced metabolism of the substance by CYP1A2.
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Abstract
Disclosed herein is a method of using colchicine. In one embodiment, the method comprises administering to a patient colchicine and a substrate of cytochrome P450 1A2 and monitoring the patient during administration of colchicine and the substrate for an adverse event. Also disclosed are articles of manufacture comprising a container containing a dosage form of colchicine and a method of manufacturing a colchicine product.
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Citations
36 Claims
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1. A method of determining risk of an adverse event in administration of colchicine comprising
determining for a patient to whom colchicine is going to be administered or is being administered whether a substance that is currently being or will be administered to the patient is a substrate of CYP1A2; - and
determining risk for the patient of an adverse event during coadministration of colchicine and the substance resulting from reduced metabolism of the substance by CYP1A2. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9-10. -10. (canceled)
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11. A method of coadministration of colchicine and a substrate of CYP1A2 to a patient comprising,
administering colchicine and a substrate of CYP1A2 to a patient in need of colchicine and the substrate; -
monitoring the patient during coadministration of the colchicine and the substrate; and adjusting the dosing of colchicine or the substrate in response to the monitoring such that an adverse event associated with the coadministration of colchicine and a substrate of CYP1A2 is avoided. - View Dependent Claims (12, 13)
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14-32. -32. (canceled)
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33. A method of administering colchicine to a patient in need thereof, comprising
receiving information that colchicine a) is metabolized by cytochrome P450 2A6, 2B6, 2C8, 2C9 or 2C19; -
b) inhibited cytochrome P450 2A6 or 2C8 enzyme activity in an in vitro inhibition study; c) activated CYP3A4 enzyme activity in an in vitro inhibition study; d) suppressed enzyme activity of cytochrome P450 1A2, 2A6, 2C19, 2D6, or 2E1 in an in vitro induction study;
ore) suppressed mRNA expression of cytochrome P450 1A2 in an in vitro induction study; and adjusting administration of colchicine and an active agent to a patient in response to the information to avoid an adverse event in the patient. - View Dependent Claims (34, 35)
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36-45. -45. (canceled)
Specification