Muscle Relaxant

Carisoprodol

Approved 6 Aug 2009OralTablet

The FDA lists this product in 28 strengths and forms.

Indications

Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use 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 is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1) Limitation of Use Should only be used for acute treatment periods up to two or three weeks (1)

Contraindications

Carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. 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)

5.1Sedation

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.

5.2Abuse, Dependence and Withdrawal Carisoprodol,

the active ingredient in carisoprodol, 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 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.

At a glance

Brand name: Carisoprodol
Pharmacologic class: Muscle Relaxant
Route: Oral
Dosage form: Tablet
Applicant: Aurobindo Pharma
Status: Prescription
FDA approval: 6 Aug 2009
Application: ANDA040792-002

Indications

Warnings and precautions

5.1Sedation

5.2Abuse, Dependence and Withdrawal Carisoprodol,

Adverse reactions

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1(844) 874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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; and 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)

6.2Post-marketing 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.

Carisoprodol

Indications

Contraindications

Warnings and precautions

5.1Sedation

5.2Abuse, Dependence and Withdrawal Carisoprodol,

At a glance

Two medicines in one question?

Carisoprodol

Indications

Contraindications

Warnings and precautions

5.1Sedation

5.2Abuse, Dependence and Withdrawal Carisoprodol,

At a glance

Two medicines in one question?

5.3Seizures

Interactions

7.1CNS Depressants

7.2CYP2C19 Inhibitors and Inducers

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Post-marketing Experience

Composition

Strengths and forms

Official product information