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Claims for Patent: 7,122,566

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Claims for Patent: 7,122,566

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)
Application Number:11/364,468
Patent Claims: 1. A method of using metaxalone for treating a patient's condition, comprising providing a patient with metaxalone; and informing the patient or a medical care worker that metaxalone affects activity of a cytochrome p450 isozyme, and that administration of metaxalone with a substance that affects activity of a cytochrome p450 isozyme can affect plasma concentration, safety, efficacy or any combination thereof of metaxalone, the substance, or both.

2. The method of claim 1, wherein the substance is an active agent with a narrow therapeutic index.

3. The method of claim 2, wherein the substance is a substrate of CYP1A2, CYP3A4, CYP2B6, CYP2C19, CYP2D6, CYP2E1, or CYP2C9.

4. The method of claim 2, wherein the substance is warfarin, phenytoin, fosphenytoin, thioridazine, or theophylline.

5. A method of using metaxalone to treat a patient's condition, comprising: providing a patient with metaxalone; and informing the patient or a medical care worker that a cytochrome p450 isozyme metabolizing metaxalone is CYP1A2 or CYP2C19 and that administration of metaxalone and a substance that is a substrate, inhibitor, or inducer of CYP1A2 or CYP2C19 can affect plasma concentration, safety, efficacy or any combination thereof of metaxalone, the substance, or both.

6. A method of using metaxalone to treat a patient's condition, comprising: providing a patient with metaxalone; and informing the patient or a medical care worker that metaxalone is an inhibitor, inducer, or substrate of a cytochrome p450 isozyme and administration of metaxalone with a substance that is an inhibitor, inducer, or substrate of the cytochrome p450 isozyme can affect the plasma concentration, safety or efficacy of the substance.

7. The method of claim 6, wherein the cytochrome p450 isozyme is CYP1A2, CYP3A4, CYP2B6, CYP2C19, CYP2D6, CYP2E1, or CYP2C9.

8. The method of claim 6, wherein the substance is an active agent with a narrow therapeutic index.

9. The method of claim 8, wherein the substance is a substrate of CYP1A2, CYP3A4, CYP2B6, CYP2C19, CYP2D6, CYP2E1, or CYP2C9.

10. The method of claim 8, wherein the active agent with the narrow therapeutic index is an inhibitor of the cytochrome p450 isozyme.

11. The method of claim 8, wherein the active agent with the narrow therapeutic index is an inducer of the cytochrome p450 isozyme.

12. The method of claim 8, wherein the active agent with the narrow therapeutic index is a substrate of the cytochrome p450 isozyme.

13. The method of claim 8, wherein the substance is warfarin, phenytoin, fosphenytoin, thioridazine, or theophylline.

14. The method of claim 1, wherein metaxalone is an inducer of the cytochrome p450 isozyme.

15. The method of claim 14, wherein the cytochrome p450 isozyme is CYP1A2 or CYP3A4.

16. The method of claim 1, wherein metaxalone is an inhibitor of the cytochrome p450 isozyme.

17. The method of claim 16, wherein the cytochrome p450 isozyme is CYP1A2, CYP2B6, CYP2C19, CYP2D6, CYP2C9, CYP2E1, or CYP3A4.

18. The method of claim 1, wherein metaxalone is a substrate of the cytochrome p450 isozyme.

19. The method of claim 18, wherein the cytochrome p450 isozyme is CYP1A2 or CYP2C19.

20. The method of claim 1, wherein the patient is a human patient.

21. The method of claim 1, wherein the patient is a patient with a musculoskeletal condition.

22. The method of claim 1, wherein the patient is a patient receiving metaxalone therapy.
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