ROZEREM ramelteon tablet film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

ramelteon (UNII: 901AS54I69) (ramelteon - UNII:901AS54I69)

Доступна з:

Avera McKennan Hospital

ІПН (Міжнародна Ім'я):

ramelteon

Склад:

ramelteon 8 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

New Drug Application

Характеристики продукта

ROZEREM- RAMELTEON TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROZEREM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ROZEREM.
ROZEREM (RAMELTEON) TABLETS
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
ROZEREM 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 ROZEREM. (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 co-morbid 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: Rozerem 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 REACTIONS, CONTACT TAKEDA PHARMACEUTICALS
AMERICA