ESZOPICLONE- eszopiclone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

ESZOPICLONE

Composition:

ESZOPICLONE 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ra

Product summary:

Eszopiclone Tablets are round, white, biconvex, film-coated tablets and are supplied as follows: The 3 mg tablets are debossed with product identification “54” over “396” on one side and plain on the other side. NDC 68071-2153-3 bottle of 30 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET
NuCare Pharmaceuticals, Inc.
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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 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.
The morning after you take eszopiclone your ability to drive safely
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 eszo

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET
NUCARE PHARMACEUTICALS, 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
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 7-8 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 tablets ( 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 anaphalactic/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 occurs ( 5.4)
_Worsening of depression or suicidal thinking _may occur: Prescribe
the least number of tablets feasible to avoid
intentional overdose ( 5.4, 5.7)
_Withdrawal effects: _symp