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warnings and cautions
5 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 ) 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, 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 PHARMAOLOGY ( 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 )].
warnings and cautions
5.2 Abuse, Dependence and Withdrawal Carisoprodol, the active ingredient in Carisoprodol Tablets, has been subject to abuse, dependence, 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 PHARMAOLOGY ( 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.
warnings and cautions
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 )].
6 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. 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% and 5.4% of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively, discontinued due to adverse events; and 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 Study Adverse Reaction Placebo (n=560) n (%) Carisoprodol Tablets 350 mg (n=279) n ( %) Drowsiness 31(6) 47(17) Dizziness 11(2) 19(7) Headache 11(2) 9(3) 6.2 Post-marketing Experience The following events have been reported during post-approval 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.
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% and 5.4% of patients treated with placebo and 350 mg of Carisoprodol Tablets, respectively, discontinued due to adverse events; and 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 Study Adverse Reaction Placebo (n=560) n (%) Carisoprodol Tablets 350 mg (n=279) n ( %) Drowsiness 31(6) 47(17) Dizziness 11(2) 19(7) Headache 11(2) 9(3)
adverse reactions
6.2 Post-marketing Experience The following events have been reported during post-approval 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.