Note: Solution may appear colorless to light yellow.ĭiazepam is a benzodiazepine derivative chemically designated as 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Each milliliter (mL) contains 5 mg diazepam 40% propylene glycol 10% alcohol 5% sodium benzoate and benzoic acid added as buffers and 1.5% benzyl alcohol added as a preservative.
For patients using diazepam more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam (see WARNINGS).ĭiazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Although diazepam is indicated only for intermittent use (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of diazepam may precipitate acute withdrawal reactions, which can be life-threatening. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. The continued use of benzodiazepines may lead to clinically significant physical dependence.Before prescribing diazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS). Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. The use of benzodiazepines, including diazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS).Limit dosages and durations to the minimum required.Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS).doi:10.18773/: RISKS FROM CONCOMITANT USE WITH OPIOIDS ABUSE, MISUSE, AND ADDICTION and DEPENDENCE AND WITHDRAWAL REACTIONS Management of benzodiazepine misuse and dependence. Benzodiazepine dependence and its treatment with low dose flumazenil. Hood SD, Norman A, Hince DA, Melichar JK, Hulse GK. Vukcević NP, Ercegović GV, Segrt Z, Djordjević S, Stosić JJ. Benzodiazepine-involved overdose deaths in the USA: 2000-2019.
FDA requiring boxed warning updated to improve safe use of benzodiazepine drug class. Remembrance increasingly includes lives lost to overdoses involving benzodiazepines.įood and Drug Administration. Overdose death rates.Ĭenters for Disease Control and Prevention. New safety measures announced for opioid analgesics, prescription opioid cough products, and benzodiazepines.
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