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Details for Patent: 7,378,434

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Details for Patent: 7,378,434

Title:Metaxalone products, method of manufacture, and method of use
Abstract: Disclosed herein is a method of using metaxalone. In one embodiment, the method comprises obtaining metaxalone from a container providing information that metaxalone affects the activity of a cytochrome p450 isozyme. In another embodiment, the method comprises informing a user that metaxalone affects the activity of a cytochrome p450 isozyme. Also included are articles of manufacture comprising a container containing a dosage form of metaxalone, wherein the container is associated with published material informing that metaxalone affects activity of a cytochrome p450 isozyme. Also disclosed are a method of treatment and a method of manufacturing a metaxalone product.
Inventor(s): Du; Jie (Lansdale, PA), Roberts; Richard H. (Lakewood, NJ)
Assignee: Mutual Pharmaceutical Company, Inc. (Philadelphia, PA)
Filing Date:Jul 07, 2006
Application Number:11/483,332
Claims:1. A method of using metaxalone for treating a musculoskeletal condition, comprising administering to a human patient metaxalone and an inhibitor or an inducer of CYP1A2; informing the human patient that metaxalone is a substrate of CYP1A2 and that administration of metaxalone and an inhibitor or an inducer of CYP1A2 can affect plasma concentration, bioavailability, safety, efficacy, or a combination comprising at least one of the foregoing of metaxalone; and monitoring the human patient's plasma concentration of metaxalone while metaxalone and the inhibitor or the inducer of CYP1A2 are administered to the human patient.

2. The method of claim 1, additionally comprising altering dosing of metaxalone based on the human patient's plasma concentration of metaxalone.

3. The method of claim 1, wherein an inhibitor of CYP1A2 is administered to the human patient and the inhibitor of CYP1A2 is amiodarone, cimetidine, a fluoroquinolone, fluvoxamine, furafylline, interferon, methoxsalen, or mibefradil.

4. The method of claim 1, wherein an inducer of CYP1A2 is administered to the human patient and the inducer of CYP1A2 is insulin, methyl cholanthrene, modafinil, nafcillin, beta-naphthoflavone, or omeprazole.

5. A method of using metaxalone for treating a musculoskeletal condition, comprising administering to a human patient metaxalone and an inhibitor or an inducer of CYP2C19; informing the human patient that metaxalone is a substrate of CYP2C19 and that administration of metaxalone and an inhibitor or an inducer of CYP2C19 can affect plasma concentration, bioavailability, safety, efficacy, or a combination comprising at least one of the foregoing of metaxalone; and monitoring the human patient's plasma concentration of metaxalone while metaxalone and the inhibitor or the inducer of CYP2C19 are administered to the human patient.

6. The method of claim 5, additionally comprising altering dosing of metaxalone based on the human patient's plasma concentration of metaxalone.

7. The method of claim 5, wherein an inhibitor of CYP2C19 is administered to the human patient and the inhibitor of CYP2C19 is chloramphenicol, cimetidine, felbamate, fluoxetine, fluvoxamine, indomethacin, ketoconazole, lansoprazole, modafinil, omeprazole, oxcarbazepine, probenicid, ticlopidine, or topiramate.

8. The method of claim 5, wherein an inducer of CYP2C19 is administered to the human patient and the inducer of CYP2Cl9 is carbamazepine, norethindrone, prednisone, or rifampicin.
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