yellow oblong tablet with "75" debossed on one side and afunctional score line on the opposite side.
NDC 68727-350-01: Bottles of 30 with child-resistant closure
NDC 68727-350-02: Bottles of 100 with child-resistant closure
SUNOSI tablets, 150 mg - yellow oblong tablet with "150" debossed on one side.
NDC 68727-351-01: Bottles of 30 with child-resistant closure
NDC 68727-351-02: Bottles of 100 with child-resistant closure
16.2 Storage
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 DependenceAdvise patients that SUNOSI is a federally controlled substance because it has the potential to beabused [see Drug Abuse and Dependence (9)]. Advise patients to keep their medication in asecure place and to dispose of unused SUNOSI as recommended in the Medication Guide.
Primary OSA Therapy Use
Inform patients that SUNOSI is not indicated to treat the airway obstruction in OSA and theyshould use a primary OSA therapy, such as CPAP, as prescribed to treat the underlyingobstruction [see Indications and Usage (1)]. SUNOSI is not a substitute for primary OSAtherapy.
Blood Pressure and Heart Rate Increases
Instruct patients that SUNOSI can cause elevations of their blood pressure and pulse rate and thatthey should be monitored for such effects [see Warnings and Precautions (5.1)].
Psychiatric Symptoms
Instruct patients to contact their healthcare provider if they experience, anxiety, insomnia,irritability, agitation, or signs of psychosis or bipolar disorders [see Warnings and Precautions
(5.2)].
Lactation
Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, andreduced weight gain [see Use in Specific Populations (8.2)].
For more information, visit www.SUNOSI.com
Distributed by:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
Protected by U.S. patent numbers: 8440715, 8877806, and 9604917
http://pp.jazzpharma.com/pi/sunosi.en.USPI.pdf
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