ESTAZOLAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Estazolam (UNII: 36S3EQV54C) (Estazolam - UNII:36S3EQV54C)

Disponible desde:

Mayne Pharma

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY ). Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. There is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see CLINICAL PHARMACOLOGY ). Estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by CYP3A (see WARNINGS and PRECAU

Resumen del producto:

Estazolam tablets 1 mg are available as white, oval, convex tablet, bisected and debossed "m" and "073" on one side, bisected and plain on the other side. Packaged in bottles of 100 (NDC 51862-073-01). Estazolam tablets 2 mg are available as pale orange, oval, convex tablet, bisected and debossed "m" and "074" on one side, plain on the other side. Packaged in bottles of 100 (NDC 51862-074-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Mayne Pharma
----------
MEDICATION GUIDE
ESTAZOLAM (ES-TAZE-OH-LAM) TABLETS, C-IV
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Rev. August 2022
What is the most important information I should know about estazolam?
•
Estazolam is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines, alcohol,
or other central nervous system depressants (CNS) (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death. Get emergency help
right away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
estazolam with opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including estazolam, which can lead to overdose and
serious side effects
including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused
or misused benzodiazepines, including estazolam. These serious side
effects may also
include delirium, paranoia, suicidal thoughts or actions, seizures,
and difficulty breathing.
Call your healthcare provider or go to the nearest hospital emergency
room right away if
you get any of these serious side effects.
•
You can develop an addiction even if you take estazolam exactly as
prescribed by your
healthcare provider.
•
Take estazolam exactly as your healthcare provider prescribed.
•
Do not share your estazolam with other people.
•
Keep estazolam in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Estazolam can cause
physical dependence and
withdrawal reactions, especially if you continue to take estazolam for
several days to several
weeks.
•
Do not suddenly stop taking estazolam. Stopping estazolam suddenly can
cause serious
and life-threatening side effects, including unusual move

Ficha técnica

ESTAZOLAM- ESTAZOLAM TABLET
MAYNE PHARMA
----------
ESTAZOLAM TABLETS CIV
Rx only
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory depression, coma, and death (see WARNINGS).
Reserve concomitant prescribing of these drugs in patients for whom
alternative treatment options are inadequate. Limit dosages and
durations to the
minimum required. Follow patients for signs and symptoms of
respiratory
depression and sedation. (see WARNINGS and PRECAUTIONS).
The use of benzodiazepines, including Estazolam, exposes users to
risks of
abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and
misuse of benzodiazepines commonly involve concomitant use of other
medications, alcohol, and/or illicit substances, which is associated
with an
increased frequency of serious adverse outcomes. Before prescribing
Estazolam and throughout treatment, assess each patient's risk for
abuse,
misuse, and addiction (see WARNINGS).
The continued use of benzodiazepines, including Estazolam, may lead to
clinically
significant physical dependence. The risks of dependence and
withdrawal
increase with longer treatment duration and higher daily dose. Abrupt
discontinuation or rapid dosage reduction of Estazolam after continued
use may
precipitate acute withdrawal reactions, which can be life-threatening.
To reduce
the risk of withdrawal reactions, use a gradual taper to discontinue
Estazolam or
reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).
DESCRIPTION
Estazolam, 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 structural formula is
represented as follows:
C
H
ClN
Each tablet, for oral administration, contains either 1 mg or 2 mg o