RAMELTEON tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69)

Доступна с:

Micro Labs Limited

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

RAMELTEON- RAMELTEON TABLET
MICRO LABS LIMITED
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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