for oral use Initial U.S. Approval: 2014
As specified in the prescribing information, empagliflozin tablets is indicated for the treatment of type 2 diabetes mellitus. JARDIANCE 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 cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.
Facts about empagliflozin tablets
pproval Date: 2014
Proprietary Name: JARDIANCE (empagliflozin) tablets
Active Ingredient(s): empagliflozin
FDA-approved use: type 2 diabetes mellitus
Dosage Form: Tablets: 10 mg, 25 mg
Medicine Approved By: US FDA
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For empagliflozin tablets
Approved accessible "empagliflozin tablets"
Jardiance (empagliflozin) tablets, which were first approved in 2014 for type 2 diabetes, were approved in 2022 to reduce the risk of cardiovascular death and hospitalization for heart failure.
JARDIANCE is a prescription medicine used: o along with diet and exercise to lower blood sugar in adults with type 2 diabetes. o to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease. • JARDIANCE is not for people with type 1 diabetes. • JARDIANCE is not for people with diabetic ketoacidosis (increased ketones in the blood or urine). • It is not known if JARDIANCE is safe and effective in children under 18 years of age. Active Ingredient: empagliflozin Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide
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JARDIANCE (empagliflozin) tablets, for oral use Initial U.S. Approval: 2014
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