Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)
Teva Pharmaceuticals USA, Inc.
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 tablets is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see Warnings and Precautions (5.1)]. - Eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)] . Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associ
Eszopiclone Tablets, USP are available as follows: Eszopiclone 1 mg tablets are light-blue, film-coated, unscored, convex, round tablets, debossed “93” on one side of the tablet and “E7” on the other side, in bottles of 30 (NDC 0093-5537-56). Eszopiclone 2 mg tablets are white, film-coated, unscored, convex, round tablets, debossed “93” on one side of the tablet and “E8” on the other side, in bottles of 100 (NDC 0093-5538-01). Eszopiclone 3 mg tablets are blue, film-coated, unscored, convex, round tablets, debossed “93” on one side of the tablet and “E9” on the other side, in bottles of 100 (NDC 0093-5539-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
ESZOPICLONE- eszopiclone tablet, film coated Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.tevausa.com/medguides. Eszopiclone (es zoe' pi klone) Tablets, Coated CIV 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 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. You also may experience sleepiness during the day. 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 th Läs hela dokumentet
ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- 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 WARNING: COMPLEX SLEEP BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. 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 (4, 5.1). 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 Patients who have experienced complex sleep behaviors after taking eszopiclone tablets (4) 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 and use with other CNS depressants and alcohol. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use Läs hela dokumentet