Prosom (Estazolam) 1mg-60 Tablets

Prosom (Estazolam) 1mg

Prosom (Estazolam) 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 tablets are scored and contain either 1 mg or 2 mg of estazolam.

Inactive Ingredients
Colloidal silicon dioxide, lactose, povidone, stearic acid, and sodium starch glycolate. Prosom (Estazolam) 1mg

In addition, the 2 mg tablets contain FD&C Red No. 40.

Prosom – Clinical Pharmacology
Pharmacokinetics
Absorption
Prosom tablets have been found to be equivalent in absorption to an orally administered solution of estazolam. In healthy subjects who received up to three times the recommended dose of Prosom, peak estazolam plasma concentrations occurred within two hours after dosing (range 0.5 to 6.0 hours) and were proportional to the administered dose, suggesting linear pharmacokinetics over the dosage range tested. Prosom (Estazolam) 1mg

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

Metabolism
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 (Estazolam) 1mg is primarily from the parent drug. The elimination of the parent drug takes place via hepatic metabolism of Prosom (Estazolam) 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 (Estazolam) 1mg

Elimination
The range of estimates for the mean elimination half-life of Prosom (Estazolam) 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 (Estazolam) 1mg

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