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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 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 anti-depressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously. 5.2 Drug Dependence, Withdrawal, and Abuse In the post marketing experience with CARISOPRODOL, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used CARISOPRODOL in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of CARISOPRODOL-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of CARISOPRODOL dependence, withdrawal, or abuse, CARISOPRODOL should be used with caution in addiction prone patients and in patients taking other CNS depressants including alcohol, and CARISOPRODOL should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort. CARISOPRODOL, and one of its metabolites, meprobamate (a controlled substance), may cause dependence. [ see Clinical Pharmacology (12.3) ]. 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 Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals NJ at 1-877-748-1970 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 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%, 2.0% and 5.4%, of patients treated with placebo, 250mg of CARISOPRODOL, and 350 mg of CARISOPRODOL, respectively, discontinued due to adverse events; and 0.5%, and 1.8% of patients treated with placebo, 250mg 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 post approval 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.