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 the risk of CV death; should be used in conjunction w/ other measures to reduce CV risk in line w/ the current standard of care. Adult patients w/ heart failure (NYHA class II-IV) independent of left ventricular ejection fraction, w/ or w/o type 2 DM. Reduce the risk of CV death & hospitalization for heart failure &/or slow kidney function decline.
Dosage/Direction for Use
Type 2 DM Initially 10 mg once daily, may be increased to 25 mg once daily in patients requiring additional glycemic control. Heart failure 10 mg once daily.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Special Precautions
Not for use in patients w/ type 1 diabetes. Patients at risk of ketoacidosis while on treatment include patients on a very low carbohydrate diet, w/ an 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; discontinue if ketoacidosis is suspected. Discontinue & institute prompt treatment if necrotizing fasciitis of the perineum (Fournier's gangrene) is suspected. Patients for whom an empagliflozin-induced drop in BP could pose a risk eg, w/ known CV disease & on antihypertensive therapy w/ history of hypotension or patients ≥75 yr. Monitor vol status (eg, physical exam, BP, lab tests including hematocrit) & electrolytes in case of conditions that may lead to fluid loss (eg, GI illness). Interrupt treatment temporarily in patients w/ complicated UTI. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Assess renal function prior to initiation & periodically during treatment ie, at least yrly. Avoid use during pregnancy. Lactation. Childn <18 yr. Type 2 DM: Not recommended in patients w/ renal impairment eGFR <30 mL/min/1.73 m2. Heart failure: Not recommended in patients w/ renal impairment eGFR <20 mL/min/1.73 m2.
Adverse Reactions
Hypoglycaemia; vol depletion. Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), necrotizing fasciitis of the 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 the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. May increase risk of hypoglycemia w/ insulin & insulin secretagogues (eg, sulphonylurea). 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
30's (P1,448.4/box)
Form
Jardiance FC tab 25 mg
Packing/Price
30's (P1,500/box)
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