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Flurazepam Full Prescribing Information

Brand Name: Dalmane
Generic Name: Flurazepam

Flurazepam (Dalmane) is used for short-term treatment of patients with insomnia. Uses, dosage, side effects of Dalmane.

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Dalmane patient information (in plain English)

Description

Dalmane (Flurazepam) is a benzodiazepine used to treat sleep disorders (insomnia).

Pharmacology

Flurazepam, a benzodiazepine derivative, is a hypnotic agent which does not appear to decrease dream time as measured by rapid eye movements (REM). Furthermore, it decreases sleep latency and number of awakenings for a consequent increase in total sleep time.

In clinical tests of insomniacs, flurazepam usually induced sleep within 22 minutes and usually provided 7 to 8 hours of sleep.

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Indications and Usage

Insomnia, characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakening. For short-term and intermittent use in patients with recurring insomnia and poor sleeping habits; however, the safety and efficacy of long-term use has not been established.

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Contraindications

Known hypersensitivity to benzodiazepines. Since clinical investigations of flurazepam have not been carried out in children, currently it is not recommended for use in children under 15 years of age.

 

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Warnings

Pregnancy and Withdrawl: The safety of the use of flurazepam in pregnancy has not been established. Therefore, flurazepam is not recommended for use during pregnancy or lactation.

Since flurazepam is also a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential. If the drug is prescribed for a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the drug if she intends to become or suspects that she is pregnant.

Several studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines.

Drug dependence: DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit forming.

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Precautions

Elderly: In elderly and debilitated patients, the initial dosage should be limited to 15 mg to preclude the development of oversedation, dizziness and/or ataxia.

Use in Emotional Disorders: The usual precautions are indicated for severely depressed patients or where there is any evidence of latent depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.

Interference with cognitive and motor performance: Patients should be cautioned against engaging in activities requiring complete mental alertness, such as in operating machinery or driving a motor vehicle, shortly after ingesting the drug.

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Drug Interactions

Potentiation of Drug Effects: Careful consideration should be given if flurazepam is to be combined with other drugs having known hypnotic or CNS depressant effects, because the pharmacological action of these agents might potentiate the action of flurazepam. Patients should be advised against the simultaneous ingestion of alcohol and other CNS depressant drugs during flurazepam therapy.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes clozapine, disulfiram, omeprazole, valproic acid, and medicines used to treat HIV infection. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

The most common adverse effects are dizziness, drowsiness, lightheadedness and ataxia. These adverse effects are particularly common in elderly and debilitated patients. Severe sedation, lethargy, disorientation, probably indicative of drug intolerance or overdosage, have been reported.

Isolated instances of headache, heartburn, upset stomach, nausea, vomiting, constipation, diarrhea, gastrointestinal pain, nervousness, apprehension, irritability, weakness, palpitations, chest pains, and genitourinary complaints have been reported.

There have also been rare occurrences of sweating, flushes, difficulty in focusing, blurred vision, faintness, hypotension, shortness of breath, pruritus, skin rash, dry mouth, bitter taste, excessive salivation, anorexia, euphoria, depression, slurred speech, confusion, restlessness, and hallucinations. Paradoxical reactions, such as excitement, stimulation and hyperactivity, have also been reported in rare instances.

Physical/Psychological Dependence:
Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit forming. As with any hypnotic, caution must be exercised in administering flurazepam to individuals known to be addiction prone or those whose history suggests they may increase the dosage on their own initiative.

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Overdose

Signs and Symptoms

Symptoms of overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension and CNS depression may be combated by judicious use of appropriate therapeutic agents. The value of dialysis has not been determined. If excitation occurs in patients following flurazepam overdosage, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be kept in mind that multiple agents may have been ingested.

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Dosage

Do not exceed the recommended dosage or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit forming.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, away from heat and light.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

Should be individualized for maximal beneficial effects. For severe insomnia, the usual adult dosage is 30 mg before retiring. In elderly and/or debilitated patients, therapy should be initiated with 15 mg until individual responses are determined.

You may experience trouble sleeping for 1 to 2 nights after you stop taking this medicine. If it continues, contact your doctor.

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How Supplied

Capsules:15 mg and 30 mg

Dalmane patient information (in plain English)

Detailed Info on Signs, Symptoms, Causes, Treatments of Anxiety Disorders


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright © 2007 Healthyplace Inc. All rights reserved.

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back to: Psychiatric Medications Pharmacology Homepage

Last Updated: 09 April 2017
Reviewed by Harry Croft, MD

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