Carisoprodol: uses, appearance and warnings

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 tablet 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 )

250 mg Tablets: Round, white to off white tablets, debossed with "NC" on one side and "250" on other side. 350 mg Tablets: Round, white to off white tablets, debossed with "NC" on one side and "350" on other side. Tablets: 250 mg, 350 mg ( 3 )

250 mg Tablets: Round, white to off white tablets, debossed with "NC" on one side and "250" on other side; available in bottles of 100 (NDC 69367-419-01). 350 mg Tablets: Round, white to off white tablets, debossed with "NC" on one side and "350" on other side; available in bottles of 100 (NDC 69367-420-01) and bottles of 500 (NDC 69367-420-05). Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature.]

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 )

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 ) 5.1 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 Abuse, Dependence, and Withdrawal Carisoprodol, the active ingredient in carisoprodol tablets, 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 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 tablets 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 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 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) ].

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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) ]. …

CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) - additive sedative effects ( 5.1 , 7.1 ) 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) ]. …