ESZOPICLONE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Advanced Rx Pharmacy of Tennessee, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

1 INDICATIONS AND USAGE Eszopiclone tablet is 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 is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone [see WARNINGS AND PRECAUTIONS (5.1)]. - Eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS (5.3)] . 8.1 Pregnancy Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identi

Produkto santrauka:

Eszopiclone tablets USP, 3 mg are dark blue coloured, round, biconvex, film-coated tablets, debossed with "LU" on one side and "Y23" on the other side. They are supplied as follows: Bottles of 30 Tablets: NDC 80425-0115-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE SECTION
MEDICATION GUIDE[Image 2]
Rx only
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:
making and eating food
talking on the phone
having sex
driving a car ("sleep-driving")
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.
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
drank alcohol that evening or before bed
take other medicines that can make you sleepy. Talk

Prekės savybės

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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ESZOPICLONE 3MG TABLETS
BOXED WARNING
WARNING: COMPLEX SLEEP BEHAVIORS
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
[see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.1)].
1. INDICATIONS AND USAGE SECTION
1 INDICATIONS AND USAGE
Eszopiclone tablet is 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).
2. DOSAGE AND ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or
3 mg if
clinically indicated. In some patients, the higher morning blood
levels of eszopiclone
following use of the 2 mg or 3 mg dose increase the risk of next day
impairment of
driving and other activities that require full alertness [see WARNINGS
AND
PRECAUTIONS (5.1)]. The total dose of eszopiclone should not exceed 3
mg, once daily
immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in
elderly or debilitated
patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4
Inhibitors
In patients with severe hepatic impairment, or in patients
coadministered eszopic