ESZOPICLONE- eszopiclone tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Preferred Pharmaceuticals Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)] . 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 rabbits (4, 8, or 16 mg/kg/day) thr

Огляд продуктів:

Eszopiclone tablets USP, 1 mg, are light blue colored, biconvex, round shaped film coated, debossed with “E” on one side and “1” on other side and are supplied as: NDC 68788-8953-1         bottle of 10 tablets NDC 68788-8953-2         bottle of 20 tablets NDC 68788-8953-3         bottle of 30 tablets NDC 68788-8953-6         bottle of 60 tablets NDC 68788-8953-9         bottle of 90 tablets Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

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, CIVInitial U.S. Approval:
2004

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ESZOPICLONE-
eszopiclone tablet, film coated  Preferred Pharmaceuticals Inc.
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Medication Guide
Eszopiclone (ES-zoe-PIK-
lone) Tablets USP, Coated C-IV
Read the Medication Guide that comes with eszopiclone
tablets before you start taking them 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 eszopiclone tablets unless
you are able to stay in bed a full night (7 to 8 hours) before
you must be active again.

sleepiness during the day

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Характеристики продукта

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
PREFERRED 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
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) (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to eszopiclone (4) (4)
WARNINGS AND PRECAUTIONS
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•
•
•
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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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PROSAR AT 866-562-4590
OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
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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 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)
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 a