Carisoprodol

Sun Pharmaceutical Industries Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use carisoprodol safely and effectively. See full prescribing information for carisoprodol tablets. Carisoprodol Tablets, USP C-IVfor Oral use Initial U.S. Approval: 1959 RECENT MAJOR CHANGES5.15.2INDICATIONS AND USAGE1 Should only be used for acute treatment periods up to two or three weeks (1) Not recommended in pediatric patients less than 16 years of age (8.4) DOSAGE AND ADMINISTRATION Recommended dose is 350 mg three times a day and at bedtime. (2) DOSAGE FORMS AND STRENGTHS3CONTRAINDICATIONS Acute intermittent porphyria (4) Hypersensitivity reactions to a carbamate such as meprobamate (4) WARNINGS AND PRECAUTIONS Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery (5.1) Additive sedative effects when used with other CNS depressants including alcohol (5.1) Cases of Drug Dependence, Withdrawal, and Abuse (5.2) Seizures (5.3) Side Effects6.1To report SUSPECTED ADVERSE REACTIONS, contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) - additive sedative effects (5.1 and 7.1)

FULL PRESCRIBING INFORMATION: CONTENTS*

• 1 CARISOPRODOL INDICATIONS AND USAGE
• 2 CARISOPRODOL DOSAGE AND ADMINISTRATION
• 3 DOSAGE FORMS AND STRENGTHS
• 4 CARISOPRODOL CONTRAINDICATIONS
• 5 WARNINGS AND PRECAUTIONS
  • 5.1 Sedation
  • 5.2 Drug Dependence, Withdrawal, and Abuse
  • 5.3 Seizures
• 6 CARISOPRODOL ADVERSE REACTIONS
  • 6.1 Clinical Studies Experience
  • 6.2 Postmarketing Experience
• 7 DRUG INTERACTIONS
  • 7.1 CNS Depressants
  • 7.2 CYP2C19 Inhibitors and Inducers
• 8 USE IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy: Pregnancy Category C.
  • 8.2 Labor and Delivery
  • 8.3 Nursing Mothers
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use
  • 8.6 Renal Impairment
  • 8.7 Hepatic Impairment
  • 8.8 Patients with Reduced CYP2C19 Activity
• 9 DRUG ABUSE AND DEPENDENCE
• 10 OVERDOSAGE
• 11 CARISOPRODOL DESCRIPTION
• 12 CLINICAL PHARMACOLOGY
  • 12.1 Mechanism of Action
  • 12.2 Pharmacodynamics
  • 12.3 Pharmacokinetics
• 13 NONCLINICAL TOXICOLOGY
  • 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
• 14 CLINICAL STUDIES
• 16 HOW SUPPLIED/STORAGE AND HANDLING
• 17 PATIENT COUNSELING INFORMATION
  • 17.1 Sedation
  • 17.2 Avoidance of Alcohol and Other CNS Depressants
  • 17.3 Carisoprodol Tablets Should Only Be Used for Short-Term Treatment
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 350 MG

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Sedation

5.2 Drug Dependence, Withdrawal, and Abuse

5.3 Seizures

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 CNS Depressants

7.2 CYP2C19 Inhibitors and Inducers

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy: Pregnancy Category C.

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Patients with Reduced CYP2C19 Activity

9 DRUG ABUSE AND DEPENDENCE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

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)Mean is the least squared mean and SE is the standard error of the mean. (95% CI)		0.4 (0.2, 0.6)
	Global Impression of Change, Mean (SE)Mean is the least squared mean and SE is the standard error of the mean.	1.9 (0.1)	2.2 (0.1)
	Difference between Carisoprodol and Placebo, Mean (SE)Mean is the least squared mean and SE is the standard error of the mean. (95% CI)		0.3 (0.1, 0.4)

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Sedation

17.2 Avoidance of Alcohol and Other CNS Depressants

17.3 Carisoprodol Tablets Should Only Be Used for Short-Term Treatment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 350 MG