RAMELTEON tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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 ef

Product summary:

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: Bottles of 30 Tablets NDC: 80425-0203-01 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RAMELTEON- RAMELTEON TABLET, FILM COATED
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDGUIDE
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

Summary of Product characteristics

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
week studies (adults
and elderly), and at the end of the six month study (adults and
elderly) [see CLINICAL
STUDIES (14)].
2. DOSAGE AND ADMINISTRATION
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 8 mg tablets are round, yellow, film coated debossed with
“I3” on one side
and “5” on the other side.
4. CONTRAINDICATIONS
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. WARNINGS AND PRECAUTIONS
5.1 Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedem