Jardiance 25 mg/1
Empagliflozin · TABLET, FILM COATED · A-S Medication Solutions
Jardiance is a tablet, film coated containing empagliflozin at 25 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Jardiance
- Generic Name
- Empagliflozin
- NDC Code (Product)
50090-4384- Manufacturer
- A-S Medication Solutions
- Strength
- 25 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA204629
- Drug Class
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Marketing Start
- 08/01/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. ( 1 ) To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. ( 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 JARDIANCE is not recommended in patients with type 1 diabetes mellitu…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assess volume status and correct volume depletion before initiating ( 2.1 ) Recommended dose is 10 mg once daily in the morning, taken with or without food ( 2.2 ) For additional glycemic control, dose may be increased to 25 mg in patients tolerating JARDIANCE ( 2.2 ) 2.1 Prior to Initiation of JARDIANCE Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2) ] . In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2) , Use in Specific Populations (8.5 , 8.6) ]. 2.2 Recommended Dosage The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, the dose may be increased to 25 mg in patients tolerating JARDIANCE. Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 . Data are insufficient to provide a dosing recommendation in patients; who have type 2 diabetes and established cardiovascular disease with an eGFR less than 30 mL/min/1.73 m 2 , or who have heart failure with an eGFR less than 20 mL/min/1.73 m 2 [see Warning…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.7) ] . Patients on dialysis [see Use in Specific Populations (8.6) ] . Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE ( 4 ) Patients on dialysis ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3 Clinically Relevant Interactions with JARDIANCE Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating JARDIANCE, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy. Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during JARDIANCE initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Ketoacidosis [see Warnings and Precautions (5.1) ] Volume Depletion [see Warnings and Precautions (5.2) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.5) ] Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in…
Frequently Asked Questions
What is Jardiance used for?
Jardiance contains Empagliflozin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Jardiance a controlled substance?
Jardiance is not classified as a controlled substance by the DEA.
What is the generic name for Jardiance?
The generic name for Jardiance is Empagliflozin. There are 10 other brand versions of Empagliflozin.
What is the NDC code for Jardiance 25 mg/1?
The NDC (National Drug Code) for Jardiance 25 mg/1 is 50090-4384, listed by A-S Medication Solutions.