Carisprodol Articles and Methods

Abstract

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 administering carisoprodol, comprising:
 administering carisoprodol to a human patient in the presence of food.   
   
   
       2 .- 4 . (canceled) 
   
   
       5 . The method of  claim 1 , wherein the administration of carisoprodol in the presence of food results in a 16% decrease in a geometric mean of C max  compared to administration in the absence of food. 
   
   
       6 . The method of  claim 5 , wherein in a study of 22 patients, the geometric mean of C max  for carisoprodol when administered under non-fasted conditions was 1680 ng/ml, and the geometric mean of C max  for carisoprodol when administered under fasted conditions was 2003 ng/ml. 
   
   
       7 . The method of  claim 5 , wherein the AUC of carisoprodol is substantially unchanged after administration of carisoprodol in the presence or absence of food. 
   
   
       8 .- 9 . (canceled) 
   
   
       10 . The method of  claim 7 , wherein the 90% confidence interval for the ratio of the geometric means between the non-fasted and fasted states for carisoprodol is within the interval of 80-125% for ln-transformed AUC 0-t  or AUC 0-INF . 
   
   
       11 . The method of  claim 7 , wherein in a study of 22 patients, the geometric mean of AUC 0-t  for carisoprodol was 6136 hr*ng/ml when administered under non-fasted conditions and 6385 hr*ng/ml when administered under fasted conditions. 
   
   
       12 . The method of  claim 7 , wherein in a study of 22 patients, the geometric mean of AUC 0-INF  for carisoprodol was 6306 hr*ng/ml when administered under non-fasted conditions and 6512 hr*ng/ml when administered under fasted conditions. 
   
   
       13 . The method of  claim 1 , wherein administration of carisoprodol in the presence or absence of food has no significant effect on the C max  or AUC of meprobamate as a metabolite of carisoprodol. 
   
   
       14 .- 15 . (canceled) 
   
   
       16 . The method of  claim 13 , wherein the 90% confidence interval for the ratio of the geometric means between the non-fasted and fasted states for meprobamate as a metabolite of carisoprodol is within the interval of 80-125% for ln-transformed AUC or C max . 
   
   
       17 . The method of  claim 13 , wherein in a study of 22 patients, the geometric mean of C max  for meprobamate as a metabolite of carisoprodol administered under non-fasted conditions was 2352 ng/ml, and the geometric mean of C max  for meprobamate as a metabolite of carisoprodol administered under fasted conditions was 2280 ng/ml. 
   
   
       18 . The method of  claim 13 , wherein in a study of 22 patients, the geometric mean of AUC 0-t  for meprobamate was 30745 hr*ng/ml as a metabolite of carisoprodol administered under non-fasted conditions and 30412 hr*ng/ml as a metabolite of carisoprodol administered under fasted conditions. 
   
   
       19 . The method of  claim 13 , wherein in a study of 22 patients, the geometric mean of AUC 0-INF  for meprobamate was 37942 hr*ng/ml as a metabolite of carisoprodol administered under non-fasted conditions and 38005 hr*ng/ml as a metabolite of carisoprodol administered under fasted conditions. 
   
   
       20 . The method of  claim 1 , wherein the patient is in need of a skeletal muscle relaxant. 
   
   
       21 . The method of  claim 20 , wherein the carisoprodol is in an oral dosage form. 
   
   
       22 . The method of  claim 21 , wherein the oral dosage form is a tablet. 
   
   
       23 . The method of  claim 22 , wherein the tablet comprises about 100 to about 1000 mg of carisoprodol. 
   
   
       24 . The method of  claim 23 , wherein the tablet comprises about 350 mg of carisoprodol. 
   
   
       25 .- 62 . (canceled) 
   
   
       63 . A method of manufacturing a carisoprodol pharmaceutical composition comprising:
 packaging a carisoprodol pharmaceutical formulation along with information   that administration of carisoprodol in the presence of food decreases the C max  for carisoprodol compared to administration in the absence of food.   
   
   
       64 .- 92 . (canceled) 
   
   
       93 . A method of maximizing the peak plasma concentration of carisoprodol experienced by a patient, comprising:
 administering a carisoprodol dosage form to a human patient in need thereof under fasted conditions.   
   
   
       94 .- 110 . (canceled) 
   
   
       111 . The method of  claim 93 , wherein the patient is in need of a skeletal muscle relaxant.