国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)
Advanced Rx Pharmacy of Tennessee, LLC
ORAL
PRESCRIPTION DRUG
1 INDICATIONS AND USAGE Eszopiclone tablet is 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 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 identi
Eszopiclone tablets USP, 3 mg are dark blue coloured, round, biconvex, film-coated tablets, debossed with "LU" on one side and "Y23" on the other side. They are supplied as follows: Bottles of 30 Tablets: NDC 80425-0115-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED Advanced Rx Pharmacy of Tennessee, LLC ---------- MEDICATION GUIDE SECTION MEDICATION GUIDE[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 完全なドキュメントを読む
ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- ESZOPICLONE 3MG TABLETS BOXED WARNING 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)]. 1. INDICATIONS AND USAGE SECTION 1 INDICATIONS AND USAGE Eszopiclone tablet is 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). 2. DOSAGE AND ADMINISTRATION SECTION 2 DOSAGE AND ADMINISTRATION 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 eszopic 完全なドキュメントを読む