Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
Add-on combination therapy w/ metformin, metformin & a sulfonylurea, metformin & pioglitazone in adult patients w/ type 2 DM to improve glycemic control when the existing therapy, along w/ diet & exercise, does not provide adequate glycemic control. For study results w/ respect to combination of therapies, effects on glycaemic control & CV events. Symptomatic chronic heart failure w/ reduced ejection fraction.
Dosage/Direction for Use
Recommended starting dose: 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥60 mL/min/1.73 m2 & requiring additional glycemic control, the dose can be increased to 25 mg once daily. Max daily dose: 25 mg. Heart failure 10 mg once daily.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Hypersensitivity. Rare hereditary problems of galactose intolerance eg, galactosaemia. Renally impaired patients w/ eGFR <45 mL/min/1.73 m2, severe renal impairment, ESRD & patients on dialysis.
Special Precautions
Not to be used in patients w/ type 1 diabetes or treatment of diabetic ketoacidosis. Patients on a very low carbohydrate diet, acute illness, pancreatic disorders suggesting insulin deficiency, insulin dose reduction, alcohol abuse, severe dehydration, history of ketoacidosis. Vol-depletion risk in patients w/ known CV disease, on antihypertensive therapy w/ history if hypotension or patients ≥75 yr; conditions that may lead to fluid loss eg, GI illness. Cardiac failure (NYHA class I-IV), complicated UTI. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. False +ve result in glucose urine test. Not recommended in patients w/ eGFR <20 mL/min/1.73 m2. Not to be used in patients w/ ESRD, on dialysis. Assessment of renal function is recommended. Hepatic injury. May effect ability to drive & use machines. Pregnancy & lactation. Childn <18 yr. Elderly ≥85 yr.
Adverse Reactions
Hypoglycemia, UTI, vag moniliasis, vulvovaginitis, balanitis & other genital infection; increased urination, vol depletion. Increased blood creatinine, haematocrit, serum lipids; decreased GFR. Ketoacidosis, urosepsis, pyelonephritis, allergic skin reactions eg, rash, urticaria, constipation.
Drug Interactions
Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycemia w/ insulin secretagogues eg, sulfonylureanylureas.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BK03 - empagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Jardiance FC tab 10 mg
Packing/Price
3 × 10's
Form
Jardiance FC tab 25 mg
Packing/Price
3 × 10's
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