Flurazepam Hydrochloride

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Overview

What is Flurazepam Hydrochloride?

Flurazepam hydrochloride is chemically 7-chloro-1-[2-(diethylamino)ethyl]-5-( -fluoro-phenyl)-1,3-dihydro-2 -1,4-benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in alcohol and very soluble in water. It has a molecular weight of 460.81 and the following structural formula:

Each capsule for oral administration contains either 15 mg or 30 mg of flurazepam hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Red No. 3, gelatin, magnesium stearate, microcrystalline cellulose, powdered cellulose, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

What does Flurazepam Hydrochloride look like?

What are the available doses of Flurazepam Hydrochloride?

Flurazepam Hydrochloride Capsules, USP are available containing either 15 mg or 30 mg of flurazepam hydrochloride, USP.

The 15 mg capsule is a hard-shell gelatin capsule with a white opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body.

The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body.

What should I talk to my health care provider before I take Flurazepam Hydrochloride?

How should I use Flurazepam Hydrochloride?

Flurazepam hydrochloride capsules, USP are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings

Since insomnia is often transient and intermittent, short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient.

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

What interacts with Flurazepam Hydrochloride?

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What are the warnings of Flurazepam Hydrochloride?

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What are the precautions of Flurazepam Hydrochloride?

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What are the side effects of Flurazepam Hydrochloride?

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What should I look out for while using Flurazepam Hydrochloride?

Flurazepam hydrochloride capsules are contraindicated in patients with known hypersensitivity to flurazepam or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of flurazepam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should not be rechallenged with flurazepam.

What might happen if I take too much Flurazepam Hydrochloride?

Manifestations of flurazepam hydrochloride overdosage include somnolence, confusion and coma. 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 hydrochloride overdosage, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be useful in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

How should I store and handle Flurazepam Hydrochloride?

Flurazepam Hydrochloride Capsules, USP are available containing either 30 mg of flurazepam hydrochloride, USP.The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Flurazepam Hydrochloride Capsules, USP are available containing either 30 mg of flurazepam hydrochloride, USP.The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Flurazepam Hydrochloride Capsules, USP are available containing either 30 mg of flurazepam hydrochloride, USP.The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Flurazepam Hydrochloride Capsules, USP are available containing either 30 mg of flurazepam hydrochloride, USP.The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Flurazepam Hydrochloride Capsules, USP are available containing either 30 mg of flurazepam hydrochloride, USP.The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Flurazepam Hydrochloride Capsules, USP are available containing either 30 mg of flurazepam hydrochloride, USP.The 30 mg capsule is a hard-shell gelatin capsule with a powder blue opaque cap and a powder blue opaque body filled with off-white to yellow powder. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Flurazepam, like other central nervous system agents of the 1,4-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (CNS). The exact mechanism of action is unknown.

Non-Clinical Toxicology

Flurazepam hydrochloride capsules are contraindicated in patients with known hypersensitivity to flurazepam or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of flurazepam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should not be rechallenged with flurazepam.

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

Dizziness, drowsiness, light-headedness, staggering, ataxia and falling can occur, particularly in elderly or debilitated persons. Severe sedation, lethargy, disorientation and coma, probably indicative of drug intolerance or overdosage, have been reported.

Flurazepam is a central nervous system (CNS) depressant and can impair daytime function even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of flurazepam may develop, patients using flurazepam should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness.

Additive effects occur with concomitant use of other CNS depressants (e.g., other benzodiazepines, opioids, tricyclic antidepressants, alcohol). Downward dose adjustment of flurazepam and concomitant CNS depressants should be considered. The potential for adverse drug interactions continues for several days following discontinuation of flurazepam, until serum levels of psychoactive metabolites decline.

Use of flurazepam with other sedative-hypnotics is not recommended. Alcohol generally should not be used during treatment with flurazepam. The risk of next-day psychomotor impairment is increased if flurazepam is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants

The following serious adverse reactions are discussed in greater detail in other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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