Jardiance 25 mg Tablet

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. …

• Assess volume status and correct volume depletion before initiating Recommended dose is 10 mg once daily in the morning, taken with or without food For additional glycemic control, dose may be increased to 25 mg in patients tolerating JARDIANCE Prior to Initiation of JARDIANCE Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions ]
• In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions , Use in Specific Populations ]
• 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 Warnings and Precautions and Use in Specific Populations ]
• JARDIANCE is contraindicated in patients on dialysis [see Contraindications ]

JARDIANCE tablets available as: 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with "S 10" on one side and the Boehringer Ingelheim company symbol on the other side. 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with "S 25" on one side and the Boehringer Ingelheim company symbol on the other side. Tablets: 10 mg, 25 mg ( 3 )

• The safety and effectiveness of JARDIANCE have not been established
• In pediatric patients

In glycemic control studies in patients with type 2 diabetes mellitus, a total of 2721 (32%) patients treated with JARDIANCE were 65 years of age and older, and 491 (6%) were 75 years of age and older. JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6) ] . …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Ketoacidosis Inform patients that ketoacidosis is a serious life-threatening condition and that cases of ketoacidosis have been reported during use of JARDIANCE, sometimes associated with illness or surgery among other risk factors
• Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated
• If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue JARDIANCE and seek medical attention immediately [see Warnings and Precautions ] . …

• Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions ]
• Patients on dialysis [see Use in Specific Populations ]
• Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE Patients on dialysis

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. …

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients on JARDIANCE may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. ( 5.1 ) Volume Depletion: Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy. …

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 femal …

8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy. The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . …

In the event of an overdose with JARDIANCE, contact the Poison Control Center. Removal of empagliflozin by hemodialysis has not been studied.

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