ESZOPICLONE- eszopiclone tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

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). Eszopiclone Tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)] . Pregnancy Category C 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 to the fetus. Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi

Produkt oppsummering:

Eszopiclone tablets are round, white, film-coated tablets and are supplied as follows: The 1 mg tablets are debossed with product identification “54 746” on one side and plain on the other side. The 2 mg tablets are debossed with product identification “54 029” on one side and plain on the other side. NDC 63187-330-90 2mg bottle of 90 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

ESZOPICLONE- ESZOPICLONE TABLET
Proficient Rx LP
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MEDICATION GUIDE
Eszopiclone (ES-zoe-PIK-lone) Tablets, Coated C-IV
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 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 rightaway ifyou findout thatyou have
doneany of the aboveactivities
after taking eszopiclone.
The morning afteryou take eszopiclone yourability to drivesafely and
think clearly may be decreased.
Do not take eszopiclone 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 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
•
waking up often during the night
Eszopiclone is not for children.
Eszopiclone is a federally controlled substance (C-IV) because it can
be abused or lead to dependence.
Keep eszopiclone in a safe place to prevent misuse and abuse. Selling
or giving away eszopiclone may
harm others, and is again

Preparatomtale

ESZOPICLONE- ESZOPICLONE TABLET
PROFICIENT RX LP
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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
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•
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DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to eszopiclone (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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ADVERSE REACTIONS
Most commonly observed adverse reactions (incidence ≥2%) were
unpleasant taste, headache, somnolence, respiratory
infection, dizziness, dry mouth, rash, anxiety, hallucinations, and
viral infections (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,
INC AT 1-800-962-8364 OR FDA AT
1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
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•
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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)
_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 m