RAMELTEON tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Advanced Rx Pharmacy of Tennessee, 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 fluvox amine [see Drug Interactions (7)] . History of angioedema while taking ramelteon. ( 4) Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination. ( 7.1) - Pediatric use: Safety and effectiveness not established. ( 8.4) - Geriatric use: No overall differences in safety and efficacy between elderly an

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: Bottles of 30 tablets NDC 80425-0343-01 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
Advanced Rx Pharmacy of Tennessee, LLC
----------
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:
•
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.
•
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.

Produktets egenskaber

RAMELTEON- RAMELTEON TABLET, FILM COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
RAMELTEON 8MG TABLETS
1 INDICATIONS AND USAGE
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)] _.
2 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)
2.1 DOSAGE IN ADULTS
The recommended dose of ramelteon tablets is 8 mg taken within 30
minutes of going
to bed. It is recommended that ramelteon tablets not be taken with or
immediately after
a high-fat meal.
The total ramelteon tablets dose should not exceed 8 mg per day.
2.2 DOSING IN PATIENTS WITH HEPATIC IMPAIRMENT
Ramelteon tablets are not recommended in patients with severe hepatic
impairment.
Ramelteon tablets should be used with caution in patients with
moderate hepatic
impairment _[see Warnings and Precautions (5.6), Clinical Pharmacology
(12.4)] _.
2.3 ADMINISTRATION WITH OTHER MEDICATIONS
Ramelteon tablets should not be used in combination with fluvoxamine.
Ramelteon
tablets should be used with caution in patients taking other CYP1A2
inhibiting drugs _[see_
_Drug Interactions (7), Clinical Pharmacology (12.5)]._
3 DOSAGE FORMS AND STRENGTHS
Ramelteon tablets are available in an 8 mg strength tablet for oral
administration.
Ramelteon tablets 8 mg are yellow, round shaped film coated tablets,
debossed with "AC
414" on one side and plain on other side.
4 CONTRAINDICATIONS
Patients who develop angioedema after treatment with ramelteon tablets
should not be
rechallenged with the drug.
Patients