belviq lorcaserin hydrochloride hemihydrate tablet
1 INDICATIONS AND USAGE BELVIQ/BELVIQ XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obese), or 27 kg/m 2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes) [ see Dosage and Administration ( 2 ) ] Limitations of Use: The safety and efficacy of coadministration of BELVIQ/BELVIQ XR with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established. The effect of BELVIQ/BELVIQ XR on cardiovascular morbidity and mortality has not been established. BELVIQ/BELVIQ XR is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obese) ( 1 ) or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes) ( 1 ) Limitations of Use: The safety and efficacy of coadministration with other products for weight loss have not been established ( 1 ) The effect of BELVIQ/BELVIQ XR on cardiovascular morbidity and mortality has not been established ( 1 )
eisai inc.
ROUND BLUE A 10
A 10 ROUND BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows: • NDC 62856-529-60 Bottle of 60 BELVIQ XR 20-mg extended-release tablets are orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows: NDC 62856-535-30 Bottle of 30 Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].
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