RAMELTEON tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Ramelteon (UNII: 901AS54I69) (Ramelteon - UNII:901AS54I69)

Tilgængelig fra:

Upsher-Smith Laboratories, LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 fluvoxamine [see Drug Interactions (7)] . Risk Summary Available data from postmarketing reports with ramelteon 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 rats at

Produkt oversigt:

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: 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.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

RAMELTEON- RAMELTEON TABLET, FILM COATED
Upsher-Smith Laboratories, LLC
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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 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.
Who sho

Produktets egenskaber

RAMELTEON- RAMELTEON TABLET, FILM COATED
UPSHER-SMITH LABORATORIES, LLC
----------
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. (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 A