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Jardiance

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
As monotherapy or in combination w/ other glucose-lowering drugs including insulin in the treatment of type 2 DM when diet & exercise alone do not provide adequate glycemic control. Patients w/ type 2 DM & established CV disease to reduce risk of CV death; used in conjunction w/ other measures to reduce CV risk in line w/ current standard of care to prevent CV deaths. Adult patients w/ heart failure (NYHA class II-IV) independent of left ventricular ejection fraction, w/ or w/o type 2 DM to reduce risk of CV death & hospitalization for heart failure; to slow kidney function decline. Adult patients w/ CKD to reduce risk of kidney disease progression (sustained decline in eGFR, end-stage kidney disease or renal death) or CV death; all-cause hospitalisation.
Dosage/Direction for Use
Type 2 DM Initially 10 mg once daily, may be increased to 25 mg once daily in patients tolerating starting dose who have eGFR ≥30 mL/min/1.73 m2 & requiring additional glycemic control. Heart failure & CKD 10 mg once daily regardless of renal function.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not to be used in patients w/ type 1 diabetes. Assess patients for ketoacidosis immediately if nonspecific symptoms eg, nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness occur, regardless of blood glucose level. Discontinue, evaluate patient, & institute prompt treatment if ketoacidosis is suspected. Patients at higher risk of ketoacidosis while on treatment include patients on very low carbohydrate diet, w/ acute illness, pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol abuse, severe dehydration, & w/ history of ketoacidosis. Consider monitoring for ketoacidosis & temporarily discontinuing treatment in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery) & monitor ketones, even if treatment has been interrupted. Evaluate patients w/ pain or tenderness, erythema, swelling in genital or perineal area, fever, malaise for necrotizing fasciitis. Discontinue & institute prompt treatment if necrotizing fasciitis of perineum (Fournier's gangrene) is suspected. Patients for whom empagliflozin-induced drop in BP could pose risk eg, w/ known CV disease, on anti-hypertensive therapy w/ history of hypotension or patients ≥75 yr. Monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes carefully in case of conditions that may lead to fluid loss (eg, GI illness). Consider temporary interruption of treatment until fluid loss is corrected; in patients w/ complicated UTI including pyelonephritis & urosepsis. Contains lactose; not to be taken by patients w/ rare hereditary conditions of galactose intolerance eg, galactosaemia. Not recommended to initiate treatment in patients on dialysis. Assess renal function prior to initiation & periodically during treatment ie, at least yrly. Avoid use during pregnancy. Discontinue lactation during treatment. Childn <18 yr. Elderly ≥75 yr.
Adverse Reactions
Hypoglycaemia; vol depletion. Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), necrotizing fasciitis of perineum (Fournier's gangrene); ketoacidosis; constipation; pruritus, allergic skin reactions (eg, rash, urticaria), angioedema; increased urination, dysuria; thirst; decreased GFR, increased blood creatinine, hematocrit & serum lipids.
Drug Interactions
May add to diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. May increase risk of hypoglycaemia w/ insulin & insulin secretagogues. Interference w/ 1,5-anhydroglucitol (1,5-AG) assay. May decrease blood lithium levels through increased renal lithium elimination.
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 (P1,448.4/box)
Form
Jardiance FC tab 25 mg
Packing/Price
30's (P1,500/box)
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