Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)
Micro Labs Limited
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 tablet 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 t
Ramelteon tablets are yellow colored, circular, biconvex, film-coated tablets, debossed with "RM" on one face and plain on other face with an approximate diameter of 7.00 mm. Bottle of 30: NDC 42571-375-30 Bottle of 100: NDC 42571-375-01 Bottle of 500: NDC 42571-375-05 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity.
Abbreviated New Drug Application
RAMELTEON- RAMELTEON TABLET MICRO LABS LIMITED ---------- 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 tablet is 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 tablet is 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 RE Přečtěte si celý dokument