WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 ) ]. The use of benzodiazepines, including flurazepam hydrochloride capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. 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. Before prescribing flurazepam hydrochloride capsules, and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [ see Warnings and Precautions ( 5.2 ) ]. The continued use of benzodiazepines, including flurazepam hydrochloride capsules, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of flurazepam hydrochloride capsules after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage [ see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.3 ) ]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation ( 5.1 , 7.1 ). The use of benzodiazepines, including flurazepam hydrochloride capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing flurazepam hydrochloride capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( 5.2 ). Abrupt discontinuation or rapid dosage reduction of flurazepam hydrochloride capsules after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage ( 2.3 , 5.3 ).
Adult Dosing
General dosing
Use the lowest dose effective for the patient. Recommended initial dose is 15 mg for women and 15 mg or 30 mg for men. Elderly or debilitated patients: recommended dose is 15 mg. 2.1
General dosing
Dosage in Adults Use the lowest dose effective for the patient, as important adverse effects of flurazepam hydrochloride capsules are dose related. The recommended initial dose is 15 mg for women and either 15 mg or 30 mg for men. The 15 mg dose can be increased to 30 mg if necessary for efficacy. The recommended initial doses for women and men are different because flurazepam clearance is lower in women . 2.2
Geriatric Dosing
General dosing
Dosage in Elderly or Debilitated Patients Elderly or debilitated patients may be especially sensitive to flurazepam. Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly or debilitated patients, it is recommended that in such patients the dosage be limited to 15 mg. Staggering and falling have also been reported, particularly in geriatric patients . 2.3 Discontinuation or Dosage Reduction of Flurazepam Hydrochloride Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [ see Warnings and Precautions and Drug Abuse and Dependence ].
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