ROZEREM- ramelteon tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

RAMELTEON

Koostis:

RAMELTEON 8 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.   The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies (14) ] . Patients who develop angioedema after treatment with ROZEREM should not be rechallenged with the drug. Patients should not take ROZEREM in conjunction with fluvoxamine (Luvox) [see Drug Interactions (7) ] . Pregnancy Category C In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses much greater than the recommended human dose (RHD) of 8 mg/day. There are no adequate and well-controlled studies in pregnant women. ROZEREM should be used during pregnancy only if the potential benefit

Toote kokkuvõte:

ROZEREM is available as round, pale orange-yellow, film-coated, 8 mg tablets, with “TAK” and “RAM-8” printed on one side, in the following quantities: NDC 54868-5649-0             Bottles of 30 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.

Volitamisolek:

New Drug Application

Toote omadused

ROZEREM - RAMELTEON TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ROZEREM is indicated for the treatment of insomnia characterized by
difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to 6
months in duration. The final formal
assessments of sleep latency were performed after 2 days of treatment
during the crossover study
(elderly only), at 5 weeks in the 6-week studies (adults and elderly),
and at the end of the 6-month study
(adults and elderly) _[see Clinical Studies (14)]_.
2 DOSAGE AND ADMINISTRATION
2.1 DOSAGE IN ADULTS
The recommended dose of ROZEREM is 8 mg taken within 30 minutes of
going to bed. It is
recommended that ROZEREM not be taken with or immediately after a
high-fat meal.
The total ROZEREM dose should not exceed 8 mg per day.
2.2 DOSING IN PATIENTS WITH HEPATIC IMPAIRMENT
ROZEREM is not recommended in patients with severe hepatic impairment.
ROZEREM 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
ROZEREM should not be used in combination with fluvoxamine. ROZEREM
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
ROZEREM is available in an 8 mg strength tablet for oral
administration.
ROZEREM 8 mg tablets are round, pale orange-yellow, film-coated, with
“TAK” and “RAM-8” printed
on one side.
4 CONTRAINDICATIONS
Patients who develop angioedema after treatment with ROZEREM should
not be rechallenged with the
drug.
Patients should not take ROZEREM in conjunction with fluvoxamine
(Luvox) _[see Drug Interactions (7)]_.
5 WARNINGS AND PRECAUTIONS
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 o