Prosom(艾司唑仑)1mg

Prosom (艾司唑仑)1mg a triazolobenzodiazepine derivative, is an oral hypnotic agent. Estazolam occurs as a fine, white, odorless powder that is soluble in alcohol and practically insoluble in water. The chemical name for estazolam is 8−chloro−6−phenyl−4H−s−triazolo[4,3-α] [1,4]benzodiazepine. The empirical formula is C16H11ClN4. The structural formula is represented as follows:

Prosom片打分并包含1毫克或2毫克艾司唑仑.

非活性成分
二氧化硅胶体、乳糖、聚烯吡酮、硬脂酸，以及淀粉羟乙酸钠。 Prosom(艾司唑仑)1mg

此外，2毫克片剂含有FD&C红色40号.

Prosom临床药理学
药物动力学
吸收
Prosom片已经发现被相当于在吸一口给予解决方案的艾司唑仑. 在健康科目收到了三倍的推荐剂量的Prosom，峰艾司唑仑等离子浓度内发生后两个小时的配量(范围为0.5到6.0个小时)，是成正比的施用的剂量，这表明线性的药物动力学的剂量范围的测试。 Prosom(艾司唑仑)1mg

Distribution
Independent of concentration, estazolam in plasma is 93% protein bound.

新陈代谢
Estazolam is extensively metabolized. Only two metabolites (1-oxo-estazolam & 4 − hydroxy − estazolam) were detected in human plasma up to 18 hrs.

The pharmacologic activity of Prosom(艾司唑仑)1mg is primarily from the parent drug. The elimination of the parent drug takes place via hepatic metabolism of Prosom(艾司唑仑)1mg to hydroxylated and other metabolites that are eliminated largely in the urine both free and conjugated. In humans, greater than 70% of a single dose of estazolam was recovered in the urine as metabolites. Less than 5% of a 2 mg dose of estazolam was excreted unchanged in the urine, with only 4% of the dose appearing in the feces. The principal urinary excretion product is an unidentified metabolite, presumed to be a metabolic product of 4-hydroxy-estazolam, accounting for at least 27% of the administered dose. 4 − hydroxy-estazolam is the major metabolite in plasma, with concentrations approaching 12% of those of the parent eight hours after administration. Urinary 4 − hydroxy − estazolam and 1-oxo-estazolam account for 11.9% and 4.4% of the dose respectively. In vitro studies with human liver microsomes indicate that the biotransformation of estazolam to the major circulating metabolite 4 − hydroxy − estazolam is mediated by cytochrome P450 3A (CYP3A). While 4-hydroxy-estazolam and the lesser metabolite, 1-oxo-estazolam, have some pharmacologic activity, their low potencies and low concentrations preclude any significant contribution to the hypnotic effect of Prosom.Prosom(艾司唑仑)1mg

Elimination
The range of estimates for the mean elimination half-life of Prosom(艾司唑仑)1mg varied from 10 to 24 hours. Radiolabel mass balance studies indicate that the main route of excretion is via the kidneys. After 5 days, 87% of the administered radioactivity was excreted in human urine. Less than 4% of the dose was excreted unchanged. Eleven metabolites were found in urine. Four metabolites were identified as 1-oxo-estazolam, 4′ − hydroxy − estazolam, 4-hydroxy-estazolam, and benzophenone, as free metabolites and glucuronides. The predominant metabolite in urine (17% of the administered dose) has not been identified, but is likely to be a metabolite of 4-hydroxy-Prosom(艾司唑仑)1mg

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