Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
As monotherapy when use of metformin is inappropriate due to intolerance or add-on combination therapy w/ other glucose-lowering drugs including insulin in type 2 DM when diet & exercise alone do not provide adequate glycaemic control. As adjunct to diet, exercise & standard care therapy to reduce incidence of CV death in patients w/ type 2 DM & established CV disease who have inadequate glycaemic control.
Dosage/Direction for Use
Initially 10 mg once daily, may be increased to 25 mg once daily if additional glycaemic control is needed. Max daily dose: 25 mg.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Special Precautions
Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Discontinue use if ketoacidosis & necrotizing fasciitis of the perineum (Fournier's gangrene) are suspected. Temporarily interrupt treatment in patients w/ complicated UTIs. Patients for whom empagliflozin-induced drop in BP pose a risk eg, w/ known CV disease, on antihypertensive therapy w/ history of hypotension or ≥75 yr. Assess renal function prior to & periodically during treatment. Monitor vol status & electrolytes in case of fluid loss. +ve test for glucose in urine. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May influence ability to drive & use machines. Not to be initiated in patients w/ eGFR <45 mL/min/1.73 m2 or CrCl <45 mL/min; ESRD or on dialysis. Not recommended in severe hepatic impairment. Hepatic injury. Not recommended during 2nd & 3rd trimester of pregnancy. Not to be used during lactation. Childn & adolescents. Not recommended in elderly ≥85 yr.
Adverse Reactions
Hypoglycaemia. Vag moniliasis, vulvovaginitis, balanitis, other genital infection, UTI (including pyelonephritis & urosepsis); generalized pruritus, rash; increased urination; increased serum lipid.
Drug Interactions
May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Potential risk of decreased efficacy w/ UGT enzyme inducers. May interfere w/ 1,5-anhydroglucitol (1,5-AG) assay.
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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