SUNOSI Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Jazz Pharmaceuticals, Inc.

Λέξεις κλειδιά

68727-350 68727-351

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1. Indications and Usage

SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations ...

2. Dosage and Administration

2.1 Important Considerations Prior to Initiating Treatment Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [see Warnings and Precautions (5.1)]. 2.2 General ...

3. Dosage Forms and Strengths

SUNOSI 75 mg – (75 mg solriamfetol equivalent to 89.3 mg of the hydrochloride salt) dark yellow oblong tablet with 75 debossed on one side and a functional score line on the opposite side. SUNOSI 150 mg ...

4. Contraindications

SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the ...

5. Warnings and Precautions

5.1 Blood Pressure and Heart Rate Increases SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion [see Adverse Reactions (6.1)]. Epidemiological ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5.1)] Psychiatric Symptoms ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Monoamine Oxidase (MAO) Inhibitors Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAO inhibitors and noradrenergic drugs ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SUNOSI during pregnancy. Healthcare providers are encouraged to register pregnant ...

8.2. Lactation

Risk Summary There are no data available on the presence of solriamfetol or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. Solriamfetol ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Clinical studies of SUNOSI in pediatric patients have not been conducted.

8.5. Geriatric Use

Of the total number of patients in the narcolepsy and OSA clinical studies treated with SUNOSI, 13% (123/930) were 65 years of age or over. No clinically meaningful differences in safety or effectiveness ...

8.6. Renal Impairment

Dosage adjustment is not required for patients with mild renal impairment (eGFR 60‑89 mL/min/1.73 m²). Dosage adjustment is recommended for patients with moderate to severe renal impairment (eGFR 15‑59 ...

9.1. Controlled Substance

SUNOSI contains solriamfetol, a Schedule IV controlled substance.

9.2. Abuse

SUNOSI has potential for abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. The abuse potential of SUNOSI 300 mg, 600 ...

9.3. Dependence

In a long-term safety and maintenance of efficacy study, the effects of abrupt discontinuation of SUNOSI were evaluated following at least 6 months of SUNOSI use in patients with narcolepsy or OSA. The ...

10. Overdosage

A specific reversal agent for SUNOSI is not available. Hemodialysis removed approximately 21% of a 75 mg dose in end stage renal disease patients. Overdoses should be managed with primarily supportive ...

11. Description

SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name (R)‑2-amino‑3‑phenylpropylcarbamate hydrochloride. ...

12.1. Mechanism of Action

The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could ...

12.2. Pharmacodynamics

Solriamfetol binds to the dopamine transporter and norepinephrine transporter with low affinity (Ki=14.2 µM and 3.7 µM, respectively), and inhibits the reuptake of dopamine and norepinephrine with low ...

12.3. Pharmacokinetics

Solriamfetol exhibits linear kinetics over the dose range of 42 to 1008 mg (approximately 0.28 to 6.7 times the maximum recommended dosage). Steady state is reached in 3 days, and once‑daily administration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Solriamfetol did not increase the incidence of tumors in rats or mice treated orally for up to 101 and 104 weeks at 35, 80, and 200 mg/kg/day (rat), and 20, 65, and 200 mg/kg/day (mouse), ...

14. Clinical Studies

14.1 Narcolepsy The efficacy of SUNOSI in improving wakefulness and reducing excessive daytime sleepiness was demonstrated in a 12‑week, multi‑center, randomized, double‑blind, placebo‑controlled, parallel-group ...

16.1. How Supplied

SUNOSI is packaged in 30‑count and 100‑count white, high density polyethylene (HDPE) bottles. SUNOSI tablets, 75 mg ‑ dark yellow oblong tablet with 75 debossed on one side and a functional score line ...

16.2. Storage and Handling

Store SUNOSI at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) (see USP controlled room temperature).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Potential for Abuse and Dependence Advise patients that SUNOSI is a federally controlled substance because it has the potential ...