ESZOPICLONE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

DIRECT RX

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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)]. 8.1 Pregnancy Teratogenic Effects: 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

Resumo do produto:

Eszopiclone tablets, 3 mg, are dark blue colored, biconvex, round shaped film coated, debossed with “E” on one side and “3” on other side and are supplied as: bottle of 100 tablets Eszopiclone tablets, 2 mg, are white to off-white colored, biconvex, round shaped film coated, debossed with “E” on one side and “2” on other side and are supplied as: bottle of 100 tablets Eszopiclone tablets, 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: bottle of 30 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].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

DIRECT RX
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Revised: 1/2020
Document Id: 9c9402dc-ee0b-6c1f-e053-2995a90adabd
34391-3
Set id: 489833bd-1905-63b6-e054-00144ff8d46c
Version: 2
Effective Time: 20200120
DIRECT RX

Características técnicas

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
DIRECT RX
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ESZOPICLONE
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).
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 tablets
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 tablets 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 tablets 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 CNS
depressant drugs because of the potentially additive effects [see
Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat
meal results in slower absorption
and would be expected to reduce the effect of eszopiclone on sleep
latency [see Clinical Pharm