Carisoprodol articles and methods
View Patent ↗A method of using carisoprodol comprises informing a user that administration of carisoprodol in the presence of food decreases the C max for carisoprodol compared to administration in the absence of food. In one embodiment, informing comprises providing printed labeling instructions. Also included are articles comprising a carisoprodol formulation and prescribing information, and methods of manufacturing carisoprodol dosage forms. Included are measures intended to increase the safe use of narrow therapeutic medications with carisoprodol.
1. A method of decreasing the peak plasma concentration of carisoprodol experienced by a patient, comprising:
administering a carisoprodol dosage form to a human patient in need thereof with food, wherein peak plasma concentration (C max ) of carisoprodol is less than C max of carisoprodol after administration of the carisoprodol dosage form without food.
2. The method of claim 1 , wherein in a study of 22 subjects, administration of the carisoprodol dosage form with food results in a 16% decreases in a geometric mean C max of carisoprodol compared to a geometric mean C max of carisoprodol after administration of the carisoprodol dosage form without food.
3. The method of claim 1 , wherein in a study of 22 subjects, the geometric mean of C max for the carisoprodol dosage form when administered under non-fasted conditions was 1680 ng/ml, and the geometric mean of C max for the carisoprodol dosage form when administered under fasted conditions was 2003 ng/ml.
4. The method of claim 1 , wherein administration of the carisoprodol dosage form with or without food has no significant effect on C max or area under the plasma concentration curve (AUC) of meprobamate resulting from metabolism of carisoprodol.
5. The method of claim 1 , wherein the carisoprodol dosage form is an oral dosage form.
6. The method of claim 5 , wherein the oral dosage form is a tablet and the tablet comprises about 100 to about 1000 mg of carisoprodol.
7. A method of administering carisoprodol to a human patient comprising:
administering carisoprodol and a substrate of cytochrome p450 isozyme CYP2C19 having a narrow therapeutic index to a human patient in need thereof, wherein the carisoprodol is administered to the patient with food.
8. The method of claim 7 , further comprising:
monitoring the blood levels of the substrate for changes in metabolism of the substrate.
9. The method of claim 1 : further comprising
timing administration of carisoprodol and administration of the substrate such that the T max for carisoprodol and the T max for the substrate occur at the most dissimilar times that can be achieved.
10. The method of claim 1 wherein the patient is in need of a skeletal muscle relaxant.
11. The method of claim 7 wherein the patient is in need of a skeletal muscle relaxant.