Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)
Medsource Pharmaceuticals
ESZOPICLONE
ESZOPICLONE 1 mg
ORAL
PRESCRIPTION DRUG
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)] . 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 a
Eszopiclone tablets 1 mg are blue colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘1’ on other side. Eszopiclone tablets 2 mg are white colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘2’ on other side. Eszopiclone tablets 3 mg are dark blue colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘3’ on other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight container with child-resistant closure.
Abbreviated New Drug Application
ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED Medsource Pharmaceuticals ---------- MEDICATION GUIDE Eszopiclone Tablets, 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 ARE ESZOPICLONE TABLETS? Eszopiclone tablets aresedative-hypnotic (sleep) medicines.Eszopiclone tablets areused 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 tablets are not for children. Eszopiclone is a federally controlled substance (C-IV) because it can be read_full_document
ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED MEDSOURCE PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESZOPICLONE 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) 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 coordination, including risk of morning impairment. Risk increases with dose. Caution patients taking 3 mg dose against driving and against activities requiring complete 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) _Wo read_full_document