RAMELTEON tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

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 should not be rechallenged with the drug. Patients should not take ramelteon in conjunction with fluvoxamine [see Drug Interactions (7)]. 8.1 Pregnancy 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 doses

Product summary:

Ramelteon tablets, 8 mg are available as light yellow to beige-coloured, round, biconvex bevel edged, film-coated tablets, debossed with "1344"on one side and plain on other side and are supplied as follows: 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

Summary of Product characteristics

RAMELTEON- RAMELTEON TABLET
DIRECT RX
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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 should not be used in combination with fluvoxamine.
Ramelteon should be used with caution
in patients taking other CYP1A2 inhibiting drugs [see Drug
Interactions (7), Clinical Pharmacology
(12.5)].
Ramelteon tablets, 8 mg are light yellow to beige-coloured, round,
biconvex bevel edged, film-coated
tablets, debossed with "1344"on one side and plain on other side.
Patients who develop angioedema after treatment with ramelteon should
not be rechallenged with the
drug.
Patients should not take ramelteon 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. Some patients have
had additional symptoms such as
dyspnea, throat closing, or nausea and vomiting that suggest
anaphylaxis. Som