Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)
Advanced Rx Pharmacy of Tennessee, LLC
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 month 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 fluvox amine [see Drug Interactions (7)] . History of angioedema while taking ramelteon. ( 4) Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination. ( 7.1) - Pediatric use: Safety and effectiveness not established. ( 8.4) - Geriatric use: No overall differences in safety and efficacy between elderly an
Ramelteon tablets are available as yellow, round shaped film coated tablets, debossed with "AC 414" on one side and plain on other side, in the following quantities: Bottles of 30 tablets NDC 80425-0343-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity.
Abbreviated New Drug Application
RAMELTEON- RAMELTEON TABLET, FILM COATED Advanced Rx Pharmacy of Tennessee, LLC ---------- 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: • 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. • 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 are ramelteon tablets? Ramelteon tablets are a hypnotic (sleep) medicine. Ramelteon tablets are used in adults for the treatment of the symptom of trouble falling asleep from insomnia. Ramelteon tablets are not for children. Aqra d-dokument sħiħ
RAMELTEON- RAMELTEON TABLET, FILM COATED ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- RAMELTEON 8MG TABLETS 1 INDICATIONS AND USAGE 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 month studies (adults and elderly), and at the end of the six month study (adults and elderly) _[see Clinical_ _Studies (14)] _. 2 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) 2.1 DOSAGE IN ADULTS The recommended dose of ramelteon tablets is 8 mg taken within 30 minutes of going to bed. It is recommended that ramelteon tablets not be taken with or immediately after a high-fat meal. The total ramelteon tablets dose should not exceed 8 mg per day. 2.2 DOSING IN PATIENTS WITH HEPATIC IMPAIRMENT Ramelteon tablets are not recommended in patients with severe hepatic impairment. Ramelteon tablets should be used with caution in patients with moderate hepatic impairment _[see Warnings and Precautions (5.6), Clinical Pharmacology (12.4)] _. 2.3 ADMINISTRATION WITH OTHER MEDICATIONS Ramelteon tablets should not be used in combination with fluvoxamine. Ramelteon tablets should be used with caution in patients taking other CYP1A2 inhibiting drugs _[see_ _Drug Interactions (7), Clinical Pharmacology (12.5)]._ 3 DOSAGE FORMS AND STRENGTHS Ramelteon tablets are available in an 8 mg strength tablet for oral administration. Ramelteon tablets 8 mg are yellow, round shaped film coated tablets, debossed with "AC 414" on one side and plain on other side. 4 CONTRAINDICATIONS Patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. Patients Aqra d-dokument sħiħ