CARISOPRODOL

CARISOPRODOL- carisoprodol tablet
RedPharm Drug, Inc.


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 Vensun Pharmaceuticals, Inc. at 1-800-385-1540 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: 7/2014

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

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

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.

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 OVERDOSAGE (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.

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