ESZOPICLONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)

Tilgjengelig fra:

West-Ward Pharmaceuticals Corp.

INN (International Name):

ESZOPICLONE

Sammensetning:

ESZOPICLONE 1 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Eszopiclone Tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Eszopiclone Tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Risk Summary: Available pharmacovigilance data with eszopiclone tablets use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. Administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowes

Produkt oppsummering:

Eszopiclone Tablets are round, white, biconvex, film-coated tablets and are supplied as follows: The 1 mg tablets are debossed with product identification “54” over “746” on one side and plain on the other side. The 2 mg tablets are debossed with product identification “54” over “029” on one side and plain on the other side. The 3 mg tablets are debossed with product identification “54” over “396” on one side and plain on the other side. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

ESZOPICLONE- ESZOPICLONE TABLET
West-Ward Pharmaceuticals Corp.
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MEDICATION GUIDE
Eszopiclone Tablets (ES-zoe-PIK-lone), coated CIV
Read the Medication Guide that comes with eszopiclone before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
doctor about your medical condition or treatment.
What is the most important information I should know about
eszopiclone?
•
Do not take more eszopiclone than prescribed.
•
Do not take eszopiclone unless you are able to stay in bed a full
night (7 to 8 hours) before you must be
active again.
•
Take eszopiclone right before you get in bed, not sooner.
Eszopiclone may cause serious side effects, including:
Complex sleep behaviors that have caused serious injury and death.
After taking eszopiclone, you may get up
out of bed while not being fully awake and do an activity that you do
not know you are doing (complex sleep
behaviors). The next morning, you may not remember that you did
anything during the night. These activities
may occur with eszopiclone whether or not you drink alcohol or take
other medicines that make you sleepy.
The morning after you take eszopiclone your ability to drive safely
and think clearly may be decreased. You
also may experience sleepiness during the day.
Do not take eszopiclone if you:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food, talking
on the phone or having sex while not fully awake) after taking
eszopiclone.
•
drank alcohol that evening or before bed
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines. Your
doctor will tell you if you can take eszopiclone with your other
medicines.
•
cannot get a full night’s sleep
What is eszopiclone?
Eszopiclone is a sedative-hypnotic (sleep) medicine. Eszopiclone is
used in adults for the treatment of a sleep
problem called insomnia. Symptoms of insomnia include:
•
trouble falling asleep
•
wa

Preparatomtale

ESZOPICLONE- ESZOPICLONE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESZOPICLONE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ESZOPICLONE TABLETS.
ESZOPICLONE TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 2004
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER ACTIVITIES WHILE
NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ESZOPICLONE. SOME OF THESE
EVENTS MAY RESULT IN SERIOUS
INJURIES, INCLUDING DEATH. DISCONTINUE ESZOPICLONE IMMEDIATELY IF A
PATIENT EXPERIENCES A COMPLEX SLEEP
BEHAVIOR (4, 5.1).
RECENT MAJOR CHANGES
Warnings and Precautions, CNS Depressant
INDICATIONS AND USAGE
Eszopiclone Tablets are indicated for the treatment of insomnia.
Eszopiclone Tablets have been shown to decrease sleep
latency and improve sleep maintenance (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg and 3 mg tablets (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
Boxed Warning 08/2019
Contraindications (4) 08/2019
Warnings and Precautions, Complex Sleep Behaviors (5.1) 08/2019
Effects and Next-Day Impairment (5.2) 12/2018
Use the lowest dose effective for the patient (2)
Recommended initial dose is 1 mg, immediately before bedtime, with at
least 7 to 8 hours remaining before the
planned time of awakening. May increase dose if clinically indicated,
to a maximum of 3 mg (2.1)
Geriatric or debilitated patients: Dose should not exceed 2 mg (2.2)
Patients with severe hepatic impairment, or taking potent CYP3A4
inhibitors: Dose should not exceed 2 mg (2.3)
Do not take with or immediately after a meal (2.5)
Patients who have experienced complex sleep behaviors after taking
Eszopiclone Tablets (4)
Known hypersensitivity to eszopiclone (4)
_CNS depressant effects:_ Impaired alertness and motor coordinatio