ESZOPICLONE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

DIRECT RX

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction s

Povzetek izdelek:

Eszopiclone tablets USP, 1 mg are light blue coloured, round, biconvex, film-coated tablets, debossed with "LU" on one side and "Y21" on the other side.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
DIRECT RX
----------
[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 to your doctor
about all of your medicines. Your
doctor will tell you

Lastnosti izdelka

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
DIRECT RX
----------
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)].
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).
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 eszopiclone with potent
CYP3A4 inhibitors, the total dose of eszopiclone tablets should not
exceed 2 mg [see WARNING
AND PRECAUTIONS (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are
combined with other central
nervous system (CNS) depressant