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Dalmane (Flurazepam Hydrochloride) - Warnings and Precautions

 
 



WARNINGS

Patients receiving Dalmane should be cautioned about possible combined effects with alcohol and other CNS depressants. Also, caution patients that an additive effect may occur if alcoholic beverages are consumed during the day following the use of Dalmane for nighttime sedation. The potential for this interaction continues for several days following discontinuance of flurazepam, until serum levels of psychoactive metabolites have declined.

Patients should also be cautioned about engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities which may occur the day following ingestion of Dalmane.

Usage in Children:    Clinical investigations of Dalmane have not been carried out in children. Therefore, the drug is not currently recommended for use in persons under 15 years of age.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines. (See DRUG ABUSE AND DEPENDENCE Section.)

PRECAUTIONS

Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly and debilitated patients, it is recommended that in such patients the dosage be limited to 15 mg. If Dalmane is to be combined with other drugs having known hypnotic properties or CNS-depressant effects, due consideration should be given to potential additive effects.

The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression; particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.

The usual precautions should be observed in patients with impaired renal or hepatic function and chronic pulmonary insufficiency.

Information for Patients:    To assure the safe and effective use of benzodiazepines, patients should be informed that since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Geriatric Use:    Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly and 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.

Following single-dose administration of flurazepam, the elimination half-life for desalkyl-flurazepam was longer in elderly male subjects compared with younger male subjects, while values between elderly and young females were not significantly different. After multiple dosing, elimination half-life of desalkyl-flurazepam was longer in all elderly subjects compared with younger subjects, and mean steady-state serum concentrations were higher only in elderly male subjects relative to younger subjects (see CLINICAL PHARMACOLOGY: Geriatric Pharmacokinetics).

Page last updated: 2006-04-16

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