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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. Carisoprodol Tablets, USP for Oral use Initial U.S. Approval: 1959 | Carisoprodol

04:41 EDT 27th August 2014 | BioPortfolio

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Table 1. Patients with Adverse Reactions in the Controlled Study
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)
IMAGE chemical-structure.jpg
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 EndpointsThe 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). in Study 1
Study Parameter Placebo Carisoprodol 350 mg
1
Number of Patients
n=269
n=273
Relief from Starting Backache, Mean (SE)Mean is the least squared mean and SE is the standard error of the mean.
1.4 (0.1)
1.8 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE) (95% CI)
0.4 (0.2, 0.6)
Global Impression of Change, Mean (SE)
1.9 (0.1)
2.2 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE) (95% CI)
0.3 (0.1, 0.4)
IMAGE 350mg-30crc.jpg

Manufacturer

Sun Pharmaceutical Industries Limited

Active Ingredients

Source

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