canagliflozin 150 mg metformin 1000 mg
1 INDICATIONS AND USAGE INVOKAMET and INVOKAMET XR are a combination of canagliflozin and metformin HCl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). Canagliflozin is indicated to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. INVOKAMET and INVOKAMET XR are a combination of canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin HCl, a biguanide, indicated: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( 1 ) Canagliflozin is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus ( 1 ) Limitations of Use INVOKAMET or INVOKAMET XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ] .
janssen pharmaceuticals, inc.
OVAL PURPLE CM 611
CM 611 OVAL PURPLE
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16 HOW SUPPLIED/STORAGE AND HANDLING INVOKAMET ® tablets are available in bottles of 60 in the strengths listed below: INVOKAMET TABLET STRENGTH canagliflozin/metformin HCl tablets 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg Color white beige yellow purple Tablet Identification CM CM CM CM 155 551 215 611 capsule-shaped, film-coated tablets NDC 50458-540-60 50458-541-60 50458-542-60 50458-543-60 INVOKAMET ® XR tablets are available in bottles of 60 in the strengths listed below: INVOKAMET XR TABLET STRENGTH canagliflozin/metformin HCl extended-release tablets 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg Color Almost white to Light orange pink orange Reddish brown Tablet Identification CM1 CM3 CM2 CM4 oblong, biconvex, film-coated tablets, a thin line on the tablet side may be visible. NDC 50458-940-01 50458-941-01 50458-942-01 50458-943-01 Storage and Handling Keep out of reach of children. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Store and dispense in the original container. Storage in a pill box or pill organizer is allowed for up to 30 days.
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