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These highlights do not include all the information needed to use carisoprodol safely and effectively. See full prescribing information for carisoprodol tablets, USP. Carisoprodol Tablets, USP for Oral use CIVInitial U.S. Approval: 1959 | Carbamazepine [Aidarex Pharmaceuticals LLC] | BioPortfolio

13:37 EST 27th January 2019 | BioPortfolio

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Table 1. Patients with Adverse Reactions in Controlled Studies
Adverse
Reaction
Placebo (n=560)
n (%)
Carisoprodol 350 mg (n=279)
n (%)
    Drowsiness
 31 (6)
 47 (17)
    Dizziness
 11 (2)
 19 (7)
    Headache
 11 (2)
 9 (3)
Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24)
350 mg Carisoprodol
 Carisoprodol
 Cmax (mcg/mL)
 1.8 ± 1
 AUCinf (mcg*hr/mL)
 7 ± 5
 Tmax (hr)
 1.7 ± 0.8
 T1/2 (hr)
 2 ± 0.5
 Meprobamate
 Cmax (mcg/mL)
 2.5 ± 0.5
 AUCinf (mcg*hr/mL)
 46 ± 9
 Tmax (hr)
 4.5 ± 1.9
 T1/2 (hr)
 9.6 ± 1.5
Table 3. Results of the Primary Efficacy Endpointsa in Study 1
Study Parameter Placebo Carisoprodol 350 mg
 a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).
b Mean is the least squared mean and SE is the standard error of the mean.
 


1
 Number of Patients
 n=269
 n=273
 
    Relief from Starting Backache, Mean (SE)b
 1.4 (0.1)
 1.8 (0.1)
 
    Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI)
   0.4
(0.2, 0.6)
 
 
    Global Impression of Change, Mean (SE)b
 1.9 (0.1)
 2.2 (0.1)
 
    Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI)
   0.3
(0.1, 0.4)
 

Carisoprodol Tablets USP, 350 mg are white colored, round shaped, biconvex, uncoated tablets, identified with ‘D’ debossed on one side and ‘31’ on the other side.             Bottles of 60                 NDC 33261-676-60

             Store at controlled room temperature 20º to 25ºC (68º to 77ºF).   Dispense in tight container.

Manufacturer

Aidarex Pharmaceuticals LLC

Active Ingredients

Source

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