Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] . Patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. Patients should not take ramelteon tablets in conjunction with fluvoxamine [see Drug Interactions (7)] . Risk Summary Available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in ra
Ramelteon Tablets, 8 mg are available as orange colored, unscored, round, biconvex tablets, debossed with “WPI” on one side and plain on the other side, in the following quantities: NDC 0591-2191-30 Bottles of 30 NDC 0591-2191-01 Bottles of 100 Dispense in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity. NDC: 63629-8264-1: 30 Tablets in a BOTTLE NDC: 63629-8264-2: 60 Tablets in a BOTTLE
Abbreviated New Drug Application
RAMELTEON- RAMELTEON TABLET Bryant Ranch Prepack ---------- MEDICATION GUIDE Ramelteon (ra mel' tee on) Tablets Read the Medication Guide that comes with ramelteon 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 ramelteon tablets? Ramelteon tablets may cause severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ramelteon tablets. After taking ramelteon 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. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with ramelteon tablets. Activities may include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking ramelteon tablets. Important: 1. Take ramelteon tablets exactly as prescribed • Do not take more ramelteon tablets than prescribed. • Take ramelteon tablets within 30 minutes of going to bed, not sooner. 2. Do not take ramelteon tablets if you: • drink alcohol • 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 ramelteon tablets with your other medicines • cannot get a full night’s sleep _______________________________________________________________________________________ ___________________________________ WHAT AR Lugege kogu dokumenti
RAMELTEON- RAMELTEON TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RAMELTEON TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAMELTEON TABLETS. RAMELTEON TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2005 INDICATIONS AND USAGE Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1) DOSAGE AND ADMINISTRATION Adult dose: 8 mg taken within 30 minutes of going to bed. (2.1) Should not be taken with or immediately after a high-fat meal. (2.1) Total daily dose should not exceed 8 mg. (2.1) DOSAGE FORMS AND STRENGTHS 8 mg tablets. (3) CONTRAINDICATIONS History of angioedema while taking ramelteon tablets. (4) Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination. (7.1) WARNINGS AND PRECAUTIONS Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. (5.1) Need to evaluate for comorbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment. (5.2) Abnormal thinking, behavioral changes, complex behaviors: May include “sleep-driving” and hallucinations. Immediately evaluate any new onset behavioral changes. (5.3) Depression: Worsening of depression or suicidal thinking may occur. (5.3) CNS effects: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug. (5.4) Reproductive effects: Include decreased testosterone and increased prolactin levels. Effect on reproductive axis in developing humans is unknown. (5.5) Patients with severe sleep apnea: Ramelteon tablets are not recommended for use in this population. (5.6) ADVERSE REACTIONS Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia. (6.1) TO REPORT SUSPECTED ADVERSE REAC Lugege kogu dokumenti