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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

05:40 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
C (mcg/mL) max
1.8 ± 1
AUC (mcg*hr/mL) inf
7 ± 5
T (hr) max
1.7 ± 0.8
T (hr) 1/2
2 ± 0.5
Meprobamate
C (mcg/mL) max
2.5 ± 0.5
AUC (mcg*hr/mL) inf
46 ± 9
T (hr) max
4.5 ± 1.9
T (hr) 1/2
9.6 ± 1.5
Table 3. Results of the Primary Efficacy Endpoints in Study 1 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).
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 uds3435.jpg

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Active Ingredients

Source

Drugs and Medications [48 Associated Drugs and Medications listed on BioPortfolio]

Carisoprodol [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use carisoprodol safely and effectively. See full prescribing information for carisoprodol.Carisoprodol Tablets, USP for Oral useInitial U...

Carisoprodol [Sun Pharmaceutical Industries Limited ]

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...

Carisoprodol [Apotheca, Inc.]

CARISOPRODOL 350MG TABLETS USP Rx Only

Carisoprodol [McKesson Packaging Services Business Unit of McKesson Corporation]

CARISOPRODOL TABLETS, USP

Carisoprodol and aspirin [Apotheca, Inc.]

CARISOPRODOL AND ASPIRIN 200MG/325MG USP Rx Only

Clinical Trials [1 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.

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