openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings and cautions
• 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)
warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 Sedation 5.2 Drug Dependence, Withdrawal, and Abuse 5.3 Seizures 5 WARNINGS AND PRECAUTIONS 5.1 Sedation Carisoprodol Tablets may 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. 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 Drug Dependence, Withdrawal, and Abuse In the postmarketing experience with Carisoprodol Tablets, 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 Tablets in combination with other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Carisoprodol Tablets dependence, withdrawal, or abuse, Carisoprodol Tablets should be used with caution in addiction prone patients and in patients taking other CNS depressants including alcohol, and Carisoprodol Tablets should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort. One of the metabolites of Carisoprodol Tablets, meprobamate (a controlled substance), may cause dependence. [see Clinical Pharmacology (12.3)]. 5.3 Seizures There have been postmarketing 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 West-ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions
6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Post-marketing Experience 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 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) 47 (17) Headache 11 (2) 9 (3) 6.2 Postmarketing Experience The following events have been reported during postapproval 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
ADVERSE REACTIONS Oral supplementation with L-tryptophan, L-arginine or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each Theramine capsule does not exceed 400 mg