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

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

Drowsiness	31 (6)	47 (17)
Dizziness	11 (2)	19 (7)
Headache	11 (2)	9 (3)

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

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

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

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)

16 HOW SUPPLIED/STORAGE AND HANDLING

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.