ROZEREM Film-coated tablet (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Takeda Pharmaceuticals America, Inc.

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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 six months in duration. The final formal ...

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 ...

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 [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 of ROZEREM. ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections: Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.1)] Abnormal thinking, ...

6.1. Clinical Trials Experience

Adverse Reactions Resulting in Discontinuation of Treatment The data described in this section reflect exposure to ROZEREM in 5373 subjects, including 722 exposed for six months or longer, and 448 subjects ...

7. Drug Interactions

7.1 Effects of Other Drugs on ROZEREM Fluvoxamine (strong CYP1A2 inhibitor) AUC0-inf for ramelteon increased approximately 190-fold, and the Cmax increased approximately 70-fold upon ...

8. Use in Specific Populations

8.6 Chronic Obstructive Pulmonary Disease The respiratory depressant effect of ROZEREM was evaluated in a crossover design study of subjects (n=26) with mild to moderate COPD after administering a single ...

8.1. Pregnancy

Risk Summary Available data from postmarketing reports with ROZEREM use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary There are no data regarding the presence of ramelteon or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Ramelteon and/or its metabolites ...

8.4. Pediatric Use

Safety and effectiveness of ROZEREM in pediatric patients have not been established. Further study is needed prior to determining that this product may be used safely in prepubescent and pubescent patients. ...

8.5. Geriatric Use

A total of 654 subjects in double-blind, placebo-controlled, efficacy trials who received ROZEREM were at least 65 years of age; of these, 199 were 75 years of age or older. No overall differences in safety ...

8.8. Hepatic Impairment

Exposure to ROZEREM was increased by four-fold in subjects with mild hepatic impairment and by more than ten-fold in subjects with moderate hepatic impairment. ROZEREM should be used with caution in patients ...

8.9. Renal Impairment

No effects on Cmax and AUC0-t of parent drug or M-II were seen. No adjustment of ROZEREM dosage is required in patients with renal impairment [see Clinical Pharmacology (12.4)] ...

9. Drug Abuse and Dependence

ROZEREM is not a controlled substance. Discontinuation of ramelteon in animals or in humans after chronic administration did not produce withdrawal signs. Ramelteon does not appear to produce physical ...

10. Overdosage

General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. As in all cases of drug overdose, ...

11. Description

ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)N[2-(1,6,7,8-tetrahydro-2Hindeno[5,4-b]furan-8-yl)ethyl]propionamide and containing one ...

12.1. Mechanism of Action

Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and relative selectivity over the MT3 receptor. The activity of ramelteon ...

12.3. Pharmacokinetics

The pharmacokinetic profile of ROZEREM has been evaluated in healthy subjects as well as in subjects with hepatic or renal impairment. When administered orally to humans in doses ranging from 4 to 64 mg, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Ramelteon was administered to mice and rats at oral doses of 0, 30, 100, 300, or 1000 mg/kg/day (mice) and 0, 15, 60, 250, or 1000 mg/kg/day (rats). Mice and rats were dosed for two years, ...

14. Clinical Studies

14.1 Controlled Clinical Trials Chronic Insomnia Three randomized, double-blind trials in subjects with chronic insomnia employing polysomnography (PSG) were provided as objective support of ROZEREMS effectiveness ...

16.1. How Supplied

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 64764-805-30 Bottles of 30 NDC 64764-805-10 Bottles ...

16.2. Storage and Handling

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.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have ...