RAMELTEON tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

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

מצב אישור:

Abbreviated New Drug Application

עלון מידע

RAMELTEON- RAMELTEON TABLET
Bryant Ranch Prepack
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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

מאפייני מוצר

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