RAMELTEON tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Direct_Rx

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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)]. 8.1 Pregnancy 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 rats at doses much greater than 36 times the recommended human dose (RHD) of 8 mg/day based on body surface area (mg/m 2) (see Data). The estimated background risk of major birth defects and miscarriage for

Ապրանքի ամփոփագիր:

Ramelteon Tablets are available as round, yellow, film coated tablets debossed with "I3" on one side and "5" on the other side in the following quantities: NDC 52817-235-30 Bottles of 30 NDC 52817-235-10 Bottles of 100 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

RAMELTEON- RAMELTEON TABLET, FILM COATED
Direct_Rx
----------
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.
Ramelteo

Ապրանքի հատկությունները

RAMELTEON- RAMELTEON TABLET, FILM COATED
DIRECT_RX
----------
RAMELTEON
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)].
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)] .
Ramelteon Tablets are available in an 8 mg strength tablet for oral
administration.
Ramelteon 8 mg tablets are round, yellow, film coated debossed with
“I3” on one side
and “5” on the other side.
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)].
5.1 Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedema involving the tongue, glottis or larynx have
been reported in
patients after taking the first or subsequent doses of Ramelteon
Tablets. Some patients
have had additional sy