CARISOPRODOL (Page 4 of 4)

14 CLINICAL STUDIES

The safety and efficacy of carisoprodol for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposus, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

In Study 1, patients were randomized to one of three treatment groups (i.e., Carisoprodol 250 mg, Carisoprodol 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Carisoprodol 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days.

The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the carisoprodol 250 mg and placebo groups in both studies.

The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.

The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.

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. The ANOVA model was used for the primary statistical comparison between the carisoprodol 250 mg and placebo groups.
Table 3. Results of the Primary Efficacy Endpoints a in Studies 1 and 2
Study Parameter Placebo Carisoprodol 250 mg Carisoprodol 350 mg
1 Number of Patients n=269 n=264 n=273
Relief from Starting Backache, Mean (SE) b 1.4 (0.1) 1.8 (0.1) 1.8 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE) b (95% CI) 0.4 (0.2, 0.5) 0.4 (0.2, 0.6)
Global Impression of Change, Mean (SE) b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE) b (95% CI) 0.2 (0.1, 0.4) 0.3 (0.1, 0.4)
2 Number of Patients n=278 n=269
Relief from Starting Backache, Mean (SE) b 1.1 (0.1) 1.8 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE) b (95% CI) 0.7 (0.5, 0.9)
Global Impression of Change, Mean (SE) b 1.7 (0.1) 2.2 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE) b (95% CI) 0.5 (0.4, 0.7)

Patients treated with carisoprodol experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

16 HOW SUPPLIED/STORAGE AND HANDLING

Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in

Bottles of 30 NDC 76420-646-30 (repackaged from NDC 50228-109-01)

Bottles of 60 NDC 76420-646-60 (repackaged from NDC 50228-109-01)

Bottles of 90 NDC 76420-646-90 (repackaged from NDC 50228-109-01)

Bottles of 100 NDC 76420-646-01 (relabeled from NDC 50228-109-01)

Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol.

Sedation
Advise patients that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [ see Warnings and Precautions (5.1) ].

Avoidance of Alcohol and Other CNS Depressants
Advise patients to avoid alcoholic beverages while taking carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [ see Warnings and Precautions (5.1) ].

Carisoprodol Should Only Be Used for Short-Term Treatment
Advise patients that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Lactation Advise nursing mothers using carisoprodol to monitor neonates for signs of sedation [ see Use in Specific Populations (8.2) ].

Relabeled and Repackaged by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

LABEL
(click image for full-size original)
CARISOPRODOL carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-646(NDC:50228-109)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARISOPRODOL (CARISOPRODOL) CARISOPRODOL 350 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SG;109
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-646-30 30 TABLET in 1 BOTTLE None
2 NDC:76420-646-60 60 TABLET in 1 BOTTLE None
3 NDC:76420-646-90 90 TABLET in 1 BOTTLE None
4 NDC:76420-646-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203374 01/27/2014
Labeler — Asclemed USA, Inc. (059888437)
Establishment
Name Address ID/FEI Operations
ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel (76420-646), repack (76420-646)

Revised: 11/2023 Asclemed USA, Inc.

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