canagliflozin 100 MG Oral Tablet Invokana
1 INDICATIONS AND USAGE INVOKANA (canagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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). 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. INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( 1 ) 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 ) Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 ( 1 ) Limitations of Use INVOKANA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . INVOKANA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 . INVOKANA is likely to be ineffective in this setting based upon its mechanism of action.
Janssen Pharmaceuticals, Inc.
OVAL YELLOW CFZ 100
CFZ 100 OVAL YELLOW
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canagliflozin 100 MG Oral Tablet Invokana
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16 HOW SUPPLIED/STORAGE AND HANDLING INVOKANA ® (
CANAGLIFLOZIN) tablets are available in the strengths and packages listed below: 100 mg tablets are yellow, capsule-shaped, film-coated tablets with "CFZ" on one side and "100" on the other side. NDC 50458-140-30 Bottle of 30 NDC 50458-140-90 Bottle of 90 NDC 50458-140-50 Bottle of 500 300 mg tablets are white, capsule-shaped, film-coated tablets with "CFZ" on one side and "300" on the other side. NDC 50458-141-30 Bottle of 30 NDC 50458-141-90 Bottle of 90 NDC 50458-141-50 Bottle of 500 Storage and Handling 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] .
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