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:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets, USP 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, USP is 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 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
Product summary:
Product: 63629-8202 NDC: 63629-8202-1 30 TABLET in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
63629-8202-1

CARISOPRODOL- carisoprodol tablet

Bryant Ranch Prepack

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and

effectively. See full prescribing information for CARISOPRODOL tablets, USP.

Carisoprodol tablets, USP for Oral use CIV

Initial U.S. Approval: 1959

INDICATIONS AND USAGE

Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions

in adults. (1)

Limitations of Use:

Should only be used for acute treatment periods up to two or three weeks (1)

DOSAGE AND ADMINISTRATION

Recommended dose is 250 mg to 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 abuse, dependence, and withdrawal (5.2, 9.2, 9.3)

Seizures (5.3)

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at (855)

724-3436 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 , 7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019

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 Abuse, Dependence, and Withdrawal

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

9.1 Controlled Substance

9.2 Abuse

9.3 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/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Sedation

17.2 Avoidance of Alcohol and Other CNS Depressants

17.3 Carisoprodol Should Only Be Used for Short-Term Treatment

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful

musculoskeletal conditions in adults.

Carisoprodol tablets, USP 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, USP is 250 mg to 350 mg three times a day and at

bedtime. The recommended maximum duration of carisoprodol tablets, USP use is up to two or three

weeks.

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

3 DOSAGE FORMS AND STRENGTHS

350 mg Tablets: round, convex, white tablets, debossed with SG 109 on one side.

4 CONTRAINDICATIONS

Carisoprodol tablets, USP is 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 has sedative properties (in the low back pain trials, 13% to 17% of patients who received

carisoprodol 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.

Since the sedative effects of carisoprodol 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 Abuse, Dependence, and Withdrawal

Carisoprodol, the active ingredient in carisoprodol tablets, USP, has been subject to abuse, dependence,

and withdrawal, misuse and criminal diversion. [see Drug Abuse and Dependence (9.1, 9.2, 9.3). Abuse of

carisoprodol tablets, USP poses a risk of overdosage which may lead to death, CNS and respiratory

depression, hypotension, seizures, and other disorders. [see over dosage(10)].

Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients

with prolonged use and a history of drug abuse. Although most of these patients took other drugs of

abuse, some patients solely abused carisoprodol. Withdrawal symptoms have been reported following

abrupt cessation of carisoprodol after prolonged use. Reported withdrawal symptoms included

insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and

psychosis. One of carisoprodol’s metabolites, meprobamate (a controlled substance), may also cause

dependence. [see Clinical Pharmacology (12.3)]

To reduce the risk of carisoprodol tablets, USP abuse assess the risk of abuse prior to prescribing.

After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal

discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate

patients and their families about abuse and on proper storage and disposal.

5.3 Seizures

There have been post-marketing reports of seizures in patients who received carisoprodol. 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 these studies, patients were treated with 250 mg of carisoprodol, 350

mg of carisoprodol, 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 these two trials. In these two

studies, 2.7%, 2%, and 5.4% of patients treated with placebo, 250 mg of carisoprodol, and 350 mg of

carisoprodol, respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients

treated with placebo, 250 mg of carisoprodol, and 350 mg of carisoprodol, 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 in the two trials described above.

Table 1. Patients with Adverse Reactions in

Controlled Studies

Adverse Reaction

Placebo

(n=560)

n (%)

Carisoprodol 250

mg

(n=548)

n(%)

Carisoprodol 350

mg

(n=279)

n (%)

Drowsiness

31 (6)

73 (13)

47 (17)

Dizziness

11 (2)

43 (8)

19 (7)

Headache

11 (2)

26 (5)

9 (3)

6.2 Postmarketing Experience

The following events have been reported during postapproval use of carisoprodol. 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 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 and meprobamate, a metabolite of carisoprodol, 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 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 could result in decreased exposure of carisoprodol and increased exposure of

meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full

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

of carisoprodol is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy: Pregnancy Category C.

There are no data on the use of carisoprodol 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 to 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 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 on the mother and the fetus during labor and

delivery.

8.3 Nursing Mothers

Very limited data in humans show that carisoprodol 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 to 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 may lead to reduced or less effective infant

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

carisoprodol is administered to a nursing woman.

8.4 Pediatric Use

The efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of

age have not been established.

8.5 Geriatric Use

The efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been

established.

8.6 Renal Impairment

The safety and pharmacokinetics of carisoprodol in patients with renal impairment have not been

evaluated. Since carisoprodol is excreted by the kidney, caution should be exercised if carisoprodol is

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 in patients with hepatic impairment have not been

evaluated. Since carisoprodol is metabolized in the liver, caution should be exercised if carisoprodol

is 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 to these patients [see Clinical Pharmacology

(12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Carisoprodol tablets, USP contains carisoprodol, USP a Schedule IV controlled substance.

Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [see

Warnings and Precautions (5.2)].

9.2 Abuse

Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory

depression, hypotension, seizures and other disorders .[seeWarnings and Precautions (5.2) and over

dosage(10)].Patients at high risk of carisoprodol abuse may include those with prolonged use of

carisoprodol, with a history of drug abuse, or those who use carisoprodol in combination with other

abused drugs.

Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding

psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a

strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a

higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal.

Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for

example, abuse or addiction may not be accompanied by tolerance or physical dependence) [see Drug

Abuse and Dependance(9.3)]

9.3 Dependence

Tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced

in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical

dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose

reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use

of carisoprodol. Reported withdrawal symptoms with carisoprodol include insomnia, vomiting,

abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis.

Instruct patients taking large doses of carisoprodol or those taking the drug for a prolonged time to not

abruptly stop carisoprodol. [see Warnings and Precautions (5.2)].

10 OVERDOSAGE

Overdosage of carisoprodol 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 overdosage.Serotonin syndrome has been reported with carisoprodol intoxication. Many

of the carisoprodol 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 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 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 overdose.Vomiting should not be induced because of the risk of CNS

and respiratory depression, and subsequent aspiration. 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.

For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital

setting in patients with large overdoses who present early and are not demonstrating CNS depression

and can protect their airway.

For more information on the management of an overdose of carisoprodol, contact a Poison Control

Center.

11 DESCRIPTION

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

crystalline powder, having a mild, characteristic odor. It is very 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 in Carisoprodol tablets USP, 350 mg include microcrystalline cellulose, lactose

monohydrate, pregelatinized starch (botanical source: maize), croscarmellose sodium, povidone, silicon

dioxide and magnesium stearate.

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 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 250 mg and 350 mg

carisoprodol (see Table 2). The exposure of carisoprodol and meprobamate was dose proportional

between the 250 mg and 350 mg doses. The C

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

after administration of a single 350 mg dose of carisoprodol tablets, which is approximately 30% of the

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

meprobamate.

Table 2. Pharmacokinetic Parameters of Carisoprodol and

Meprobamate (Mean ± SD, n=24)

250 mg

Caris oprodol

350 mg

Caris oprodol

Caris oprodol

(mcg/mL)

1.2 ± 0.5

1.8 ± 1.0

(mcg*hr/mL)

4.5 ± 3.1

7.0 ± 5.0

(hr)

1.5 ± 0.8

1.7 ± 0.8

T1/2 (hr)

1.7 ± 0.5

2.0 ± 0.5

Meprobamate

(mcg/mL)

1.8 ± 0.3

2.5 ± 0.5

(mcg*hr/mL)

32 ± 6.2

46 ± 9.0

(hr)

3.6 ± 1.7

4.5 ± 1.9

T1/2 (hr)

9.7 ± 1.7

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 (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol.

Therefore, carisoprodol 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% to 50%

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

subjects.

Patients with Reduced CYP2C19 Activity: Carisoprodol 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% to 5% and in Asians is

approximately 15% to 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 was 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 was 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.

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, 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 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.

Table 3. Results of the Primary Efficacy Endpoints

in Studies 1 and 2

Study

Parameter Placebo

caris oprodol

250 mg

caris oprodol

350 mg

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. The ANOVA model was used for

the primary statistical comparison between the

carisoprodol 250 mg and placebo groups.

Number

of Patients

n=269

n=264

n=273

Relief from Starting Backache, Mean (SE)

1.4 (0.1)

1.8 (0.1)

1.8 (0.1)

Difference between carisoprodol

and Placebo, Mean (SE) (95% CI)

(0.2,

0.5)

(0.2, 0.6)

Global Impression of change, Mean (SE)

1.9 (0.1)

2.2 (0.1)

2.2 (0.1)

Difference between carisoprodol and Placebo,

Mean (SE) (95% CI)

(0.1,

0.4)

(0.1, 0.4)

Number

of Patients

n=278

n=269

Relief from Starting Backache, Mean (SE)

1.1 (0.1)

1.8 (0.1)

Difference between carisoprodol

and Placebo, Mean (SE) (95% CI)

(0.5,

0.9)

Global Impression of change, Mean (SE)

1.7 (0.1)

2.2 (0.1)

Difference between carisoprodol and Placebo,

Mean (SE) (95% CI)

(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

Product: 63629-8202

NDC: 63629-8202-1 30 TABLET in a BOTTLE

17 PATIENT COUNSELING INFORMATION

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

carisoprodol.

17.1 Sedation

Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been

a

b

b

b

b

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)].

17.2 Avoidance of Alcohol and Other CNS Depressants

Patients should be advised 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)].

17.3 Carisoprodol Should Only Be Used for Short-Term Treatment

Patients should be advised 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.

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

Rev. 01/19

CARISOPRODOL 350MG(CIV) TABLET

CARISOPRODOL

carisoprodol tablet

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -

8 20 2(NDC:50 228 -10 9 )

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Bryant Ranch Prepack

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

CARISOPRODOL

350 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

12mm

Flavor

Imprint Code

SG;10 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 20 2-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 3374

0 1/27/20 14

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 20 2) , RELABEL(6 36 29 -8 20 2)

Revised: 8/2019

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