Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
TEMAZEPAM
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
N05CD07
TEMAZEPAM
30MG
CAPSULE
TEMAZEPAM 30MG
ORAL
100/500
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0114415001; AHFS:
CANCELLED POST MARKET
2014-09-19
PRODUCT MONOGRAPH RATIO-TEMAZEPAM TEMAZEPAM 15 MG AND 30 MG CAPSULES, USP HYPNOTIC RATIOPHARM INC. CANADA, J7J 1P3 D-1017 CONTROL #: 133554 DATE OF REVISION: JANUARY 4, 2010 Page 2 PRODUCT MONOGRAPH RATIO-TEMAZEPAM TEMAZEPAM 15 MG AND 30 MG CAPSULES, USP HYPNOTIC ACTIONS AND CLINICAL PHARMACOLOGY General: Temazepam is a benzodiazepine with hypnotic properties. Benzodiazepines act as depressants of the central nervous system (CNS). It is believed that benzodiazepines enhance or facilitate the effects of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Benzodiazepines act as agonists at the benzodiazepine receptors sites. The benzodiazepine-GABA receptor-chloride ionophore complex functions mainly in the gating of the chloride channel. Benzodiazepines are thought to produce their pharmacological effects by facilitating GABA-mediated transmission in the CNS, which reportedly increase the frequency of the chloride channel opening. In sleep laboratory studies, the effect of temazepam 15 mg and 30 mg, was compared to placebo over a two week period. There was a linear dose-response improvement in total sleep time and sleep latency with significant drug-placebo differences occurring for total sleep time at both doses, and for sleep latency at the higher dose. REM sleep was essentially unchanged and slow wave sleep was decreased. Page 3 Rebound insomnia: A transient syndrome, known as "rebound insomnia", whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, may occur on withdrawal of hypnotic treatment. In the sleep laboratory studies, no measurable effects on daytime alertness or performance occurred following temazepam treatment or during the withdrawal period, even though a transient sleep disturbance in some sleep parameters was observed following the withdrawal of the higher doses. The duration of hypnotic effect and the profile of unwanted effects may be influenced by the alpha (distribution) and beta (elimination) half-lives of the administered drug and any activ Soma hati kamili