ESTAZOLAM tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ESTAZOLAM (UNII: 36S3EQV54C) (ESTAZOLAM - UNII:36S3EQV54C)

থেকে পাওয়া:

Golden State Medical Supply, Inc.

INN (আন্তর্জাতিক নাম):

ESTAZOLAM

রচনা:

ESTAZOLAM 1 mg

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ESTAZOLAM- ESTAZOLAM TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
ES TAZOLAM
TABLETS, USP C-IV
REVISED: NOVEMBER 2014
RX ONLY
DESCRIPTION
Estazolam, USP, 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-4_H_-_s_-triazolo[4,3-α][1,4]benzodiazepine. The
molecular
formula is C16H11CIN4 and its molecular weight is 294.75. The
structural formula is represented as
follows:
Each tablet, for oral administration, contains either 1 mg or 2 mg of
estazolam, USP. In addition, each
tablet contains the following inactive ingredients: docusate sodium,
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, sodium benzoate, sodium starch
glycolate and stearic acid. The 2
mg tablets also contain FD&C Red #40 aluminum lake.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
_Absorption_
Estazolam 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 estazolam, peak
estazolam plasma concentrations occurred within two hours after dosing
(range 0.5 to 6 hours) and were
proportional to the administered dose, suggesting linear
pharmacokinetics over the dosage range tested.
_Distribution_
Independent of concentration, estazolam in plasma is 93% protein
bound.
_Metabolism_
Estazolam is extensively metabolized. Only two metabolites
(1-oxo-estazolam and 4-hydroxy-
estazolam) were detected in human plasma up to 18 hours.
The pharmacologic activity of estazolam is primarily from the parent
drug. The elimination of the parent
drug takes place via hepatic metabolism of estazolam 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