Carisoprodol description, usages, side effects, indications, overdosage, supplying and lots more!

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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*




FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE




[see Dosage and Administration (2)]

2 DOSAGE AND ADMINISTRATION


3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS

5.1 Sedation


see ADVERSE REACTIONS (6.1)

5.2 Drug Dependence, Withdrawal, and Abuse




see Clinical Pharmacology (12.3)

5.3 Seizures


) see Overdosage (10)

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience




see Clinical Studies (14)


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)

6.2 Postmarketing Experience




Cardiovascular: see Overdosage (10)

Central Nervous System: see Overdosage (10)

Gastrointestinal:

Hematologic:

7 DRUG INTERACTIONS

7.1 CNS Depressants


see Warnings and Precautions (5.1)

7.2 CYP2C19 Inhibitors and Inducers


see Clinical Pharmacology (12.3)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy: Pregnancy Category C.




Teratogenic effects:

Nonteratogenic effects: in-uteroin-utero

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


see Clinical Pharmacology (12.3)

9 DRUG ABUSE AND DEPENDENCE


see Warnings and Precautions (5.2)

In vitro

10 OVERDOSAGE




Treatment of Overdosage:

contact a Poison Control Center.

11 DESCRIPTION


122424
Carisoprodol

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action




12.2 Pharmacodynamics




12.3 Pharmacokinetics


maxmax
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
Absorptionmax

Metabolism

Elimination

Gender:

Patients with Reduced CYP2C19 Activity:

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitro in vitro S. typhimurium in vivo

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










Storage:



17 PATIENT COUNSELING INFORMATION


17.1 Sedation


see Warnings and Precautions (5.1)

17.2 Avoidance of Alcohol and Other CNS Depressants


see Warnings and Precautions (5.1)

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




To 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


Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 350 MG


NDC 62756-446-01
Carisoprodol Tablets, USP C-IV
350 mg
Rx only
30 TABLETS
SUN PHARMA
Carisoprodol

Carisoprodol

Carisoprodol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-446
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARISOPRODOL CARISOPRODOL 350 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
CROSCARMELLOSE SODIUM
POVIDONE K30
talc
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm 446 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-446-01 30 in 1 BOTTLE
2 NDC:62756-446-02 100 in 1 BOTTLE
3 NDC:62756-446-03 100 in 1 BOTTLE
4 NDC:62756-446-05 500 in 1 BOTTLE
5 NDC:62756-446-04 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040755 2007-02-27


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