ESZOPICLONE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Pharmaceuticals Inc.

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). 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 lowest dose was app

Produkt oppsummering:

Eszopiclone Tablets, USP are available containing 1 mg, 2 mg or 3 mg of eszopiclone, USP. The 1 mg tablets are buff, film-coated, round, unscored tablets debossed with M on one side of the tablet and EZ over 1 on the other side. They are available as follows: NDC 0378-5270-01 bottles of 100 tablets The 2 mg tablets are buff, film-coated, round, unscored tablets debossed with M on one side of the tablet and EZ over 2 on the other side. They are available as follows: NDC 0378-5271-01 bottles of 100 tablets The 3 mg tablets are buff, film-coated, round, unscored tablets debossed with M on one side of the tablet and EZ over 3 on the other side. They are available as follows: NDC 0378-5272-01 bottles of 100 tablets 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Eszopiclone Tablets, USP CIV
(es″ zoe pik′ lone)
Read the Medication Guide that comes with eszopiclone tablets 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
tablets?
•
Do not take more eszopiclone tablets than prescribed.
•
Do not take eszopiclone tablets unless you are able to stay in bed a
full night (7 to 8 hours) before you
must be active again.
•
Take eszopiclone tablets right before you get in bed, not sooner.
Eszopiclone tablets may cause serious side effects, including:
Complex sleep behaviors that have caused serious injury and death.
After taking eszopiclone tablets, 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 tablets whether or not you
drink alcohol or take other medicines
that make you sleepy.
Reported activities and behaviors include:
•
doing activities when you are asleep like:
o
making and eating food
o
talking on the phone
o
having sex
o
driving a car (“sleep-driving”)
o
sleep walking
Stop taking eszopiclone tablets and call your healthcare provider
right away if you find out that you have
done any of the above activities after taking eszopiclone tablets.
The morning after you take eszopiclone tablets your ability to drive
safely and think clearly may be
decreased. You also may experience sleepiness during the day.
Do not take eszopiclone tablets 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 tablets.
•
dra

Preparatomtale

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
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 TABLETS. SOME
OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH.
DISCONTINUE ESZOPICLONE
TABLETS IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR
(4, 5.1).
RECENT MAJOR CHANGES
Boxed Warning 8/2019
Contraindications (4) 8/2019
Warnings and Precautions, Complex Sleep Behaviors (5.1) 8/2019
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment (5.2) 12/2018
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 (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
Use the lowest dose effective for the patient (2)
Recommended initial dose is 1 mg, immediately before bedtime, with at
least 7-8 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 moto