ESZOPICLONE- eszopiclone tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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 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) ]. Risk Summary   Available pharmacovigilance data with eszopiclone 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 organ

Product summary:

Eszopiclone tablets USP, 1 mg are light blue colored, film coated, round, biconvex beveled edge tablets debossed with “RDY” on one side and “629” on other side and are supplied in bottles of 30’s, 100’s  and 500’s.   Bottles of 30                                                               NDC 55111-629-30 Bottles of 100                                                             NDC 55111-629-01 Bottles of 500                                                             NDC 55111-629-05   Eszopiclone tablets USP, 2 mg are white colored, film coated, round, biconvex beveled edge tablets debossed with “RDY” on one side and “619” on other side and are supplied in bottles of 30’s, 90’s, 100’s , 500’s and unit dose package of 90 (9 x 10).  Bottles of 30                                                               NDC 55111-619-30 Bottles of 90                                                               NDC 55111-619-90 Bottles of 100                                                             NDC 55111-619-01 Bottles of 500                                                             NDC 55111-619-05 Unit dose package of 90 (9 x 10)                               NDC 55111-619-09   Eszopiclone tablets USP, 3 mg are dark blue colored, film coated, round, biconvex beveled edge tablets debossed with “RDY” on one side and “617” on other side and are supplied in bottles of 30’s, 90’s, 100’s , 500’s and unit dose package of 90 (9 x 10).  Bottles of 30                                                               NDC 55111-617-30 Bottles of 90                                                               NDC 55111-617-90 Bottles of 100                                                             NDC 55111-617-01 Bottles of 500                                                             NDC 55111-617-05 Unit dose package of 90 (9 x 10)                               NDC 55111-617-09   Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
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MEDICATION GUIDE
Eszopiclone Tablets USP, Coated C-IV
(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 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 tablets in a safe place to prev

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, COATED
REMEDYREPACK 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
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment ( 5.1) 12/2018
INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia.
Eszopiclone has 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
coordinationincluding risk of morning impairment. Risk increases
with dose. Cautionpatients taking 3 mg dose against driving and
against activities requiringcomplete 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 occurs (5.4)
_Worsening of Depression or Suicidal Thinking may occur_: Prescribe
the least number of tablets fe