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Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
Type 2 DM as monotherapy in adults & childn ≥10 yr inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to intolerance; as add-on combination therapy w/ other glucose-lowering medicinal products (eg, insulin) & when diet & exercise are inadequate. Reduction of CV death risk in adults w/ type 2 DM & established CV disease. Reduction of CV death & hospitalization risk for heart failure in adults w/ heart failure (NYHA class II-IV). CKD in adults.
Dosage/Direction for Use
Monotherapy & add-on combination therapy Initially 10 mg once daily. Patient tolerating empagliflozin 10 mg once daily Dose may be increased to max: 25 mg once daily. Heart failure & CKD 10 mg once daily.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Special Precautions
Discontinue use if ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene) are suspected. Not to be used in type 1 diabetes or diabetic ketoacidosis. Patients w/ 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/ CV disease, on antihypertensive therapy w/ history of hypotension; conditions leading to fluid loss eg, GI illness; complicated UTI eg, pyelonephritis or urosepsis. Assess renal function prior to & periodically during treatment. Monitor ketones in situations predisposing ketoacidosis eg, prolonged fasting due to acute illness or surgery. Counsel patients on routine preventive foot care. Positive test for glucose in urine. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended to be initiated in renal impairment (eGFR <20 mL/min/1.73 m2) & severe hepatic impairment. Hepatic injury. Not recommended during 2nd & 3rd trimesters of pregnancy. Not to be used during lactation. Childn <10 yr w/ type 2 DM; <18 yr w/ heart failure & CKD. Elderly ≥75 yr.
Adverse Reactions
Hypoglycaemia; vol depletion. Vag moniliasis, vulvovaginitis, balanitis, other genital infection, UTI eg, pyelonephritis & urosepsis; thirst; constipation; generalised pruritus, allergic skin reactions eg, rash, urticaria; increased urination; increased serum lipids.
Drug Interactions
Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Decreased blood lithium levels. Decreased efficacy w/ UGT inducers. Interference w/ 1,5-anhydroglucitol 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
30's
Form
Jardiance FC tab 25 mg
Packing/Price
30's
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