CARISOPRODOL- carisoprodol tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)
Available from:
Aidarex Pharmaceuticals LLC
INN (International Name):
CARISOPRODOL
Composition:
CARISOPRODOL 350 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see DOSAGE AND ADMINISTRATION (2)]. Carisoprodol Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. There are no data on the use of Carisoprodol Tablets during human pregnancy.  Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival.  The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic.  Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an incre
Product summary:
Carisoprodol Tablets USP, 350 mg, are White, Round, Unscored Tablets imprinted “WW 176”, are available in: Bottles of 60 tablets Storage :  Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Authorization status:
Abbreviated New Drug Application
Authorization number:
33261-387-60

CARISOPRODOL- carisoprodol tablet

Aidarex Pharmaceuticals LLC

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

Carisoprodol Tablets, USP C-IV

Rx Only

These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively.

See full prescribing information for Carisoprodol Tablets.

Carisioprodol Tablets, USP for Oral Use.

Initial U.S. Approval: 1959

RECENT MAJOR CHANGES

Warnings and Precautions, Sedation (5.1) 10/2009

Warnings and precautions, Drug Dependence, Withdrawal, and Abuse (5.2) 10/2009

INDICATIONS AND USAGE

Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal

conditions. (1)

Important Limitations:

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 STRENGTHS

Tablets: 350 mg (3)

CONTRAINDICATIONS

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)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001 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)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2012

FULL PRESCRIBING INFORMATION: CONTENTS*

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

16 HOW SUPPLIED

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

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful

musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to

two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been

established and because acute, painful musculoskeletal conditions are generally of short duration. [see

DOSAGE AND ADMINISTRATION (2)].

2 DOSAGE AND ADMINISTRATION

The recommended dose of Carisoprodol Tablets is 350 mg three times a day and at bedtime. The

recommended maximum duration of Carisoprodol Tablets use is up to two or three weeks.

3 DOSAGE FORMS AND STRENGTHS

Sections or subsections omitted from the full prescribing information are not listed.

Carisoprodol Tablets, USP 350 mg are White, Round, Unscored Tablets Imprinted "WW 176".

4 CONTRAINDICATIONS

Carisoprodol Tablets are contraindicated in patients with a history of acute intermittent porphyria or a

hypersensitivity reaction to a carbamate such as meprobamate.

5 WARNINGS AND PRECAUTIONS

5.1 Sedation

Carisoprodol Tablets have sedative properties (in the low back pain trials, 13% to 17% of patients who

received Carisoprodol Tablets experienced sedation compared to 6% of patients who received

placebo) [see ADVERSE REACTIONS (6.1) ] and may impair the mental and/or physical abilities

required for the performance of potentially hazardous tasks such as driving a motor vehicle or

operating machinery. There have been post-marketing reports of motor vehicle accidents associated

with the use of Carisoprodol Tablets.

Since the sedative effects of Carisoprodol Tablets and other CNS depressants (e.g., alcohol,

benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be

exercised with patients who take more than one of these CNS depressants simultaneously.

5.2 Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with Carisoprodol Tablets, cases of dependence, withdrawal, and abuse

have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in

patients who have had a history of addiction or who used Carisoprodol Tablets in combination with

other drugs with abuse potential. However, there have been post-marketing adverse event reports of

Carisoprodol Tablets-associated abuse when used without other drugs with abuse potential.

Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce

the chance of Carisoprodol Tablets dependence, withdrawal, or abuse, Carisoprodol Tablets should be

used with caution in addiction-prone patients and in patients taking other CNS depressants including

alcohol, and Carisoprodol Tablets should not be used more than two to three weeks for the relief of

acute musculoskeletal discomfort.

Carisoprodol Tablets and one of its metabolites, meprobamate (a controlled substance), may cause

dependence [see CLINICAL PHARMACOLOGY 12.3) ].

5.3 Seizures

There have been postmarketing reports of seizures in patients who received Carisoprodol Tablets.

Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse,

illegal drugs, and alcohol) [see OVERDOSAGE(10)].

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates

observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of

another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized,

multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back

pain [see CLINICAL STUDIES (14) ]. In the study, patients were treated with 350 mg of Carisoprodol

Tablets, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years

old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in the trial. In the study, 2.7%, 2%,

and 5.4 %, of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively,

discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo and 350

mg of Carisoprodol Tablets, respectively, discontinued due to central nervous system adverse

reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than

placebo in patients treated with Carisoprodol Tablets in the trial described above.

Table 1 – Patients with Adverse Reactions in Controlled Studies

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

The following events have been reported during postapproval use of Carisoprodol Tablets. Because

these reactions are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see OVERDOSAGE (10) ].

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache,

depressive reactions, syncope, insomnia, and seizures [see OVERDOSAGE (10) ].

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia.

7 DRUG INTERACTIONS

7.1 CNS Depressants

The sedative effects of Carisoprodol Tablets and other CNS depressants (e.g., alcohol,

benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be

exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant

use of Carisoprodol Tablets and meprobamate, a metabolite of Carisoprodol Tablets, is not

recommended [see WARNINGS AND PRECAUTIONS (5.1)].

7.2 CYP2C19 Inhibitors and Inducers

Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate [see CLINICAL

PHARMACOLOGY (12.3)]. Co-administration of CYP2C19 inhibitors, such as omeprazole or

fluvoxamine, with Carisoprodol Tablets could result in increased exposure of carisoprodol and

decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St.

John's Wort, with Carisoprodol Tablets could result in decreased exposure of carisoprodol and

increased exposure of meprobamate. Low dose aspirin also showed induction effect on CYP2C19. The

full pharmacological impact of these potential alterations of exposures in terms of either efficacy or

safety of Carisoprodol Tablets is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy: Pregnancy Category C.

There are no data on the use of Carisoprodol Tablets during human pregnancy. Animal studies indicate

that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal

survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic.

Retrospective, post-marketing studies do not show a consistent association between maternal use of

meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of

carisoprodol. There was no increase in the incidence of congenital malformations noted in

reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing

studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of

congenital malformations following first trimester exposure. Across studies that indicated an increased

risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and

postnatal survival at maternal doses equivalent to 1-1.5 times the human dose (based on a body surface

area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted

into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on

mental or motor development or IQ scores. Carisoprodol Tablets should be used during pregnancy

only if the potential benefit justifies the risk to the fetus.

8.2 Labor and Delivery

There is no information about the effects of Carisoprodol Tablets on the mother and the fetus during

labor and delivery.

8.3 Nursing Mothers

Very limited data in humans show that Carisoprodol Tablets is present in breast milk and may reach

concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed

infant received about 4-6% of the maternal daily dose through breast milk and experienced no adverse

effects. However, milk production was inadequate and the baby was supplemented with formula. In

lactation studies in mice, female pup survival and pup weight at weaning were decreased. This

information suggests that maternal use of Carisoprodol Tablets may lead to reduced or less effective

infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when

Carisoprodol Tablets are administered to a nursing woman.

8.4 Pediatric Use

The efficacy, safety, and pharmacokinetics of Carisoprodol Tablets in pediatric patients less than 16

years of age have not been established.

8.5 Geriatric Use

The efficacy, safety, and pharmacokinetics of Carisoprodol Tablets in patients over 65 years old have

not been established.

8.6 Renal Impairment

The safety and pharmacokinetics of Carisoprodol Tablets in patients with renal impairment have not

been evaluated. Since Carisoprodol Tablets are excreted by the kidney, caution should be exercised if

Carisoprodol Tablets are administered to patients with impaired renal function. Carisoprodol is

dialyzable by hemodialysis and peritoneal dialysis.

8.7 Hepatic Impairment

The safety and pharmacokinetics of Carisoprodol Tablets in patients with hepatic impairment have not

been evaluated. Since Carisoprodol Tablets are metabolized in the liver, caution should be exercised if

Carisoprodol Tablets are administered to patients with impaired hepatic function.

8.8 Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to carisoprodol. Therefore, caution

should be exercised in administration of Carisoprodol Tablets to these patients [see CLINICAL

PHARMACOLOGY (12.3)].

9 DRUG ABUSE AND DEPENDENCE

Carisoprodol Tablets are not a controlled substance [see WARNINGS AND PRECAUTIONS (5.2)].

Discontinuation of carisoprodol in animals or in humans after chronic administration can produce

withdrawal signs, and there are published case reports of human carisoprodol dependence.

In vitro studies demonstrate that carisoprodol elicits barbiturate-like effects. Animal behavior studies

indicate that carisoprodol produces rewarding effects. Monkeys self administer carisoprodol. Drug

discrimination studies using rats indicate that carisoprodol has positive reinforcing and discriminative

effects similar to barbital, meprobamate, and chlordiazepoxide.

10 OVERDOSAGE

Overdosage of Carisoprodol Tablets commonly produces CNS depression. Death, coma, respiratory

depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred

vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with

Carisoprodol Tablets overdosage. Many of the Carisoprodol Tablets overdoses have occurred in the

setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects

of an overdose of Carisoprodol Tablets and other CNS depressants (e.g., alcohol, benzodiazepines,

opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the

recommended dosage. Fatal accidental and non-accidental overdoses of Carisoprodol Tablets have

been reported alone or in combination with CNS depressants

Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical

presentation of the Carisoprodol Tablets overdose. Induced emesis is not recommended due to the risk

of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric

lavage should be considered soon after ingestion (within one hour). Circulatory support should be

administered with volume infusion and vasopressor agents if needed. Seizures should be treated with

intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In

cases of severe CNS depression, airway protective reflexes may be compromised and tracheal

intubation should be considered for airway protection and respiratory support.

The following types of treatment have been used successfully with an overdose of meprobamate, a

metabolite of Carisoprodol Tablets: activated charcoal (oral or via nasogastric tube), forced diuresis,

peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary

output is necessary and overhydration should be avoided. Observe for possible relapse due to

incomplete gastric emptying and delayed absorption. For more information on the management of an

overdose of Carisoprodol Tablets, contact a Poison Control Center.

11 DESCRIPTION

Carisoprodol Tablets are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline

powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely

soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH.

Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-

propyl-1,3-propanediol dicarbamate and the molecular formula is C

H N O , with a molecular

weight of 260.33. The structural formula is:

Other Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline

cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of carisoprodol in relieving discomfort associated with acute painful

musculoskeletal conditions has not been clearly identified.

In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal

activity in the spinal cord and in the descending reticular formation of the brain.

12.2 Pharmacodynamics

Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.

A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to

which these properties of meprobamate contribute to the safety and efficacy of Carisoprodol Tablets is

unknown.

12.3 Pharmacokinetics

The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover

study of 24 healthy subjects (12 male and 12 female) who received single doses of 350 mg

Carisoprodol Tablets (see Table 2). The C

of meprobamate was 2.5 ± 0.5 µg/mL (mean ± SD) after

administration of a single 350 mg dose of Carisoprodol Tablets, which is approximately 30% of the

of meprobamate (approximately 8 µg/mL) after administration of a single 400 mg dose of

meprobamate.

Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24)

350 mg Carisoprodol Tablets

Carisoprodol

C

(µg/mL)

1.8 ± 1.0

AUC

(µg*hr/mL)

7.0 ± 5.0

T

(hr)

1.7 ± 0.8

T

(hr)

2.0 ± 0.5

max

inf

max

1/2

Meprobamate

C

(µg/mL)

2.5 ± 0.5

AUC

(µg*hr/mL)

46 ± 9.0

T

(hr)

4.5 ± 1.9

T

(hr)

9.6 ± 1.5

Absorption: Absolute bioavailability of carisoprodol has not been determined. The mean time to peak

plasma concentrations (T

) of carisoprodol was approximately 1.5 to 2 hours. Co-administration of a

high-fat meal with Carisoprodol Tablets (350 mg tablet) had no effect on the pharmacokinetics of

carisoprodol. Therefore, Carisoprodol Tablets may be administered with or without food.

Metabolism: The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme

CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with

Reduced CYP2C19 Activity below).

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination

half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.

Gender: Exposure of carisoprodol is higher in female than in male subjects (approximately 30-50% on

a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male

subjects.

Patients with Reduced CYP2C19 Activity: Carisoprodol Tablets should be used with caution in patients

with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19

metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced

exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor

metabolizers in Caucasians and African Americans is approximately 3 - 5% and in Asians is

approximately 15 - 20%.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of

carisoprodol.

Carisoprodol Tablets were not formally evaluated for genotoxicity. In published studies, carisoprodol

was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but

was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in

vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of

metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was

not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without

metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating

blood cells.

Carisoprodol Tablets were not formally evaluated for effects on fertility. Published reproductive

studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive

cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200

mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and

sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750

mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times

a day, based on a body surface area comparison. The significance of these findings for human fertility

is not known.

max

inf

max

1/2

14 CLINICAL STUDIES

The safety and efficacy of Carisoprodol Tablets for the relief of acute, idiopathic mechanical low back

pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. 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

pulposis, 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 two treatment groups (i.e., Carisoprodol Tablets 350 mg,

or placebo). In the study, 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 the study.

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.

Table 3. Results of the Primary Efficacy Endpoints

in Study 1

Parameter

Placebo

Number of Patients

n=269

Relief for Starting Backache, Mean (SE)

1.4(0.1)

Difference between Carisoprodol Tablets and Placebo, Mean (SE)

(95% CI)

Global Impression of Change, Mean (SE)

1.9 (0.1)

Difference between Carisoprodol and Placebo, Mean (SE)

(95% CI)

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).

Mean is the least squared mean and SE is the standard error of the mean.

Patients treated with Carisoprodol Tablets experienced improvement in function as

measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3

and 7.

16 HOW SUPPLIED

Carisoprodol Tablets USP, 350 mg, are White, Round, Unscored Tablets imprinted “WW 176”,

are available in:

Bottles of 60 tablets

Storage:

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

a

b

b

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

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

Carisoprodol Tablets.

17.1 Sedation

Patients should be advised that Carisoprodol Tablets may cause drowsiness and/or dizziness, and has

been associated with motor vehicle accidents. Patients should be advised to avoid taking Carisoprodol

Tablets before engaging in potentially hazardous activities such as driving a motor vehicle or operating

machinery [see WARNINGS AND PRECAUTIONS (5.1)].

17.2 Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking Carisoprodol Tabletsl 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) ].

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

Patients should be advised that treatment with Carisoprodol Tablets 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 Tablets, 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.

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at

1-877-233-2001, or FDA at 1-800-1088 or www.fda.gov/medwatch.

Manufactured by:

West-ward Pharmaceutical Corp

Eatontown, NJ 07724

Repackaged by:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Revised January 2012

PRINCIPAL DISPLAY PANEL

Carisoprodol Tablets, USP

350 mg

NDC 33261-387-60

CARISOPRODOL

carisoprodol tablet

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code (Source )

NDC:3326 1-

38 7(NDC:0 143-1176 )

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CARISO PRO DO L (UNII: 219 25K48 2H) (CARISOPRODOL - UNII:219 25K48 2H)

CARISOPRODOL

350 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

METHYLCELLULO SE ( 10 0 CPS) (UNII: 4GFU244C4J)

Product Characteristics

Color

WHITE (White)

S core

no sco re

S hap e

ROUND (ro und)

S iz e

12mm

Flavor

Imprint Code

WW;176

Contains

Aidarex Pharmaceuticals LLC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:3326 1-38 7-6 0

6 0 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 124

0 8 /30 /20 10

Labeler -

Aidarex Pharmaceuticals LLC (801503249)

Revised: 8/2012

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