ESZOPICLONE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Mylan Institutional Inc.

INN (International ime):

ESZOPICLONE

Sastav:

ESZOPICLONE 2 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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). Eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)] . There are no adequate and well-controlled studies in pregnant women. Eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk

Proizvod sažetak:

Eszopiclone Tablets, USP are available containing 2 mg or 3 mg of eszopiclone, USP. 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 51079-349-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). 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 51079-414-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Mylan Institutional Inc.
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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 that you may not
know are happening to you. These side
effects include:
•
sleepiness during the day
•
not thinking clearly
•
act strangely, confused, or upset
•
"sleep-walking" or doing other activities when you are asleep like:
•
eating
•
talking
•
having sex
•
driving a car
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.
Do not take eszopiclone tablets if you:
•
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 tablets with your
other medicines
•
cannot get a full night’s sleep
What are eszopiclone tablets?
Eszopiclone tablets are a sedative-hypnotic (sleep) medicine.
Eszopiclone tablets are used in adults for the
treatment of a sleep problem called insomnia. Symptoms of insomnia
include:
•
trouble falling asleep
•
waking up often during the night
Eszopiclone tablets are not for children.
Eszopiclone tablets are a federally controlled substance (C-IV)
b

Svojstava lijeka

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
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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
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 5/2014
Warnings and Precautions ( 5) 5/2014
Studies Pertinent to Safety Concerns for Sedative Hypnotic Drugs (
14.3) 5/2014
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
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg and 3 mg. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to eszopiclone ( 4)
WARNINGS AND PRECAUTIONS
_CNS depressant effects:_ Impaired alertness and motor coordination,
including risk of morning impairment. Risk
increases with dose. Caution patients taking 3 mg dose against driving
and against activities requiring complete mental
alertness during the morning after use. ( 5.1)
_Evaluate for Co-morbid Diagnoses:_ Reevaluate if insomnia persists
after 7 to 10 days of use. ( 5.2)
_Severe Anaphylactic/Anaphylactoid Reactions _(angioedema and
anaphylaxis have been reported): Do not rechallenge if
such reactions occur. ( 5.3)
_Abnormal Thinking, Behavioral Changes (e.g., hallucinations), Complex
Behaviors (e.g., “sleep-driving”): Immediately_
_evaluate if