Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
TRIAZOLAM
PFIZER CANADA ULC
N05CD05
TRIAZOLAM
0.25MG
TABLET
TRIAZOLAM 0.25MG
ORAL
10X7 TABLETS/BLISTER
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0112970002; AHFS:
CANCELLED POST MARKET
2007-05-29
PRODUCT MONOGRAPH HALCION * (triazolam tablets USP) 0.125 mg and 0.25 mg tablets Hypnotic Pfizer Canada Inc Date of Preparation: 17,300 Trans-Canada Highway September 17, 2003 Kirkland, Quebec H9J 2M5 Control No. 086680 * TM Pharmacia Enterprises S.A. Pfizer Canada Inc, Licensee © Pfizer Canada Inc 2003 PRODUCT MONOGRAPH HALCION * 2 0.125 mg and 0.25 mg tablets THERAPEUTIC CLASSIFICATION HYPNOTIC ACTIONS HALCION (triazolam) is a benzodiazepine hypnotic with a very short elimination half-life (about 3 hours). In sleep laboratory studies of one to 21 days duration, triazolam significantly decreased sleep latency, increased the duration of sleep and decreased the number of nocturnal awakenings. However, after two weeks of consecutive nightly administration, the drug's effect on total wake time was decreased, and the values recorded in the last third of the night approached baseline levels. On the first and/or second night after drug discontinuance (first or second post-drug night), total time asleep, and percentage of time spent sleeping frequently were significantly decreased, and sleep latency significantly increased when compared to baseline (predrug) nights. This effect is referred to as "REBOUND" INSOMNIA. 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 active metabolites formed. When half-lives are long, the drug or metabolites may accumulate during periods of nightly administration and be associated with impairments of cognitive and motor performance during waking hours. If half-lives are short, the drug and metabolites will be cleared before the next dose is ingested, and carry-over effects related to sedation or CNS depression should be minimal or absent. However, during nightly use and for an extended period, pharmacodynamic tolerance or adaptation to some effects of benzodiazepine hypnotics may develop. If the drug has a very short elimination half- life, it is possible tha Soma hati kamili