ESTAZOLAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

ESTAZOLAM

Composition:

ESTAZOLAM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estazolam tablets, USP are 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 WARNIN

Product summary:

Estazolam Tablets, USP 1 mg are white, scored, diamond shaped compressed tablets imprinted with WATSON on one side of the tablet and on the other side with 744 on the left side of the score and 1 on the right side of the score, supplied in bottles of 100 (NDC 0591-0744-01). Estazolam Tablets, USP 2 mg are dark pink, scored, diamond shaped compressed tablets imprinted with WATSON on one side of the tablet and on the other side with 745 on the left side of the score and 2 on the right side of the score, supplied in bottles of 100 (NDC 0591-0745-01). 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). Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA  Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA  Rev. F 11/2022

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Estazolam (es taz'oh lam)
Tablets, USP C-IV
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 movements, responses, or expressions,
seizures, sudden and severe mental
or nervous system

Summary of Product characteristics

ESTAZOLAM- ESTAZOLAM TABLET
ACTAVIS PHARMA, INC.
----------
ESTAZOLAM TABLETS, USP C-IV
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, 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 structural formula
is represented as
follows:
C
H
ClN
M. W. 294.75
Each tablet, for oral administrat