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Flurazepam

(British Approved Name, US Adopted Name, rINN)

Drug Nomenclature

International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):

Synonyms: Fluratsepaami; Flurazepam; Flurazepamum
BAN: Flurazepam
INN: Flurazepam [rINN (en)]
INN: Flurazepam [rINN (es)]
INN: Flurazépam [rINN (fr)]
INN: Flurazepamum [rINN (la)]
INN: Флуразепам [rINN (ru)]
Chemical name: 7-Chloro-1-(2-diethylaminoethyl)-5-(2-fluorophenyl)-1,3-dihydro-1,4-benzodiazepin-2-one
Molecular formula: C21H23ClFN3O =387.9
CAS: 17617-23-1
ATC code: N05CD01
Read code: y01x3

Pharmacopoeias. In Japan.

Drug Approvals

(British Approved Name Modified, rINNM)

International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish):

Synonyms: Fluratsepaamimonohydrokloridi; Flurazepám-monohidroklorid; Flurazepam hydrochlorid; Flurazepam, monohidrocloruro de; Flurazepami Hydrochloridum; Flurazepami Monohydrochloridum; Flurazepammonohydroklorid; Flurazepamo monohidrochloridas
BAN: Flurazepam Monohydrochloride [BANM]
INN: Flurazepam Monohydrochloride [rINNM (en)]
INN: Monochidrocloruro de flurazepam [rINNM (es)]
INN: Flurazépam, Monochlorhydrate de [rINNM (fr)]
INN: Flurazepami Monohydrochloridum [rINNM (la)]
INN: Флуразепама Моногидрохлорид [rINNM (ru)]
Molecular formula: C21H23ClFN3O,HCl =424.3
CAS: 36105-20-1
ATC code: N05CD01

 

Pharmacopoeias. In Europe and Japan.

 

Flurazepam_30mg

European Pharmacopoeia, 6th ed. (Flurazepam Monohydrochlonde). A white or almost white crystalline powder. Very soluble in water freely soluble in alcohol. A 5% solution in water has a pH of 5.0 to 6.0. Protect from light.

Drug Approvals

(British Approved Name Modified, rINNM)

Synonyms: Flurazepam, dihidrocloruro de; NSC-78559; Ro-5-6901
BAN: Flurazepam Dihydrochloride [BANM]
USAN: Flurazepam Hydrochloride
INN: Flurazepam Dihydrochloride [rINNM (en)]
INN: Dihidrocloruro de flurazepam [rINNM (es)]
INN: Flurazépam, Dichlorhydrate de [rINNM (fr)]
INN: Flurazepami Dihydrochloridum [rINNM (la)]
INN: Флуразепама Дигидрохлорид [rINNM (ru)]
Molecular formula: C21H23ClFN3O,2HCl =460.8
CAS: 1172-18-5
ATC code: N05CD01

Pharmacopoeias. In China, and US.

The United States Pharmacopeia 31, 2008 (Flurazepam Hydrochloride). An off-white to yellow crystalline powder. Is odourless or has a slight odour. Soluble 1 in 2 of water, 1 in 4 of alcohol, 1 in 90 of chloroform, 1 in 3 of methyl alcohol, 1 in 69 of isopropyl alcohol, 1 in 5000 of ether and of petroleum spirit, and 1 in 2500 of benzene. A solution in water is acid to litmus. Store in airtight containers. Protect from light.

Dependence and Withdrawal

As for Diazepam.

Adverse Effects, Treatment, and Precautions

As for Diazepam.

Effects on the liver. Reports of cholestatic jaundice after the use of flurazepam.

Effects on taste. Flurazepam had been reported to cause dysgeusia.

Porphyria. Flurazepam has been associated with acute attacks of porphyria and is considered unsafe in porphyric patients.

Renal impairment. Five patients on maintenance haemodialy-sis developed encephalopathy attributed to flurazepam and diazepam.

Interactions

As for Diazepam.

Pharmacokinetics

Flurazepam is readily absorbed from the gastrointestinal tract. It undergoes extensive first-pass metabolism and is excreted in the urine, chiefly as conjugated metabolites. The major active metabolite is N-desalkylflurazepam, which is reported to have a half-life ranging from 47 to 100 hours or more.

Metabolism. The metabolism of flurazepam was studied in 4 healthy male subjects given 30 mg daily for 2 weeks.A hydroxyethyl metabolite was present in the blood shortly after a dose. The N-desalkyl metabolite, the major metabolite in the blood, had a half-life ranging from 47 to 100 hours. Steady-state concentrations were reached after 7 to 10 days and were about 5 to 6 times greater than those observed on day 1. Results from a study in 3 patients indicated that some metabolism of flurazepam may occur in the small bowel mucosa.

Uses and Administration

Flurazepam is a long-acting benzodiazepine with general properties similar to those of diazepam. It is used as a hypnotic in the short-term management of insomnia. In the USA flurazepam is given as the dihydrochloride and doses are expressed in terms of this salt. Flurazepam dihydrochloride 30 mg is equivalent to about 25.3 mg of flurazepam. Doses of 15 to 30 mg orally at night are given. In the UK flurazepam is given as the monohydrochloride although doses are expressed in terms of the base flurazepam monohydrochloride 32.8 mg is equivalent to about 30 mg of flurazepam. Doses equivalent to 15 to 30 mg of flurazepam at night are given. A maximum initial dose of 15 mg has been suggested in the UK and the USA for elderly or debilitated patients.

Preparations

British Pharmacopoeia 2008: Flurazepam Capsules

The United States Pharmacopeia 31, 2008: Flurazepam Hydrochloride Capsules.

Proprietary Preparations

Argentina: Fordrim

Austria: Staurodorm

Belgium: Staurodorm

Brazil: Dalmadorm

Canada: Dalmane

Germany: Dalmadorm Staurodorm Neu

Hong Kong: Dalmadorm

India: Fluraz

Indonesia: Dalmadorm

Ireland: Dalmane

Italy: Dalmadorm Felison Flunox Remdue Valdorm

The Netherlands: Dalmadorm

Portugal: Dalmadorm Morfex

South Africa: Dalmadorm

Singapore: Dalmadorm

Spain: Dormodor

Switzerland: Dalmadorm

Thailand: Dalmadorm

UK: Dalmane

USA: Dalmane

Venezuela: Fluralema

 

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