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Jardiance適糖達

Jardiance

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Empagliflozin
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM, as monotherapy when use of metformin is considered inappropriate due to intolerance; or as add-on combination therapy w/ other glucose-lowering medicinal products including insulin. Risk reduction of CV death in patients w/ type 2 DM & established CV disease. 10-mg FC tab: Treatment of symptomatic chronic heart failure w/ reduced ejection fraction.
Dosage/Direction for Use
Glycaemic control & risk reduction of CV death 10 mg once daily, can be increased to 25 mg once daily if additional glycaemic control is required. Heart failure 10 mg once daily. In heart failure patients w/ or w/o type 2 DM, 10 mg may be initiated or continued down to an eGFR 20 mL/min/1.73 m2 or CrCl 20 mL/min.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Rare hereditary conditions that may be incompatible w/ an excipient. For glycaemic control & risk reduction of CV death: Patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease & patients on dialysis. For treatment of heart failure in patients w/ or w/o type 2 DM: 10 mg is not recommended in patients w/ eGFR <20 mL/min/1.73 m2 or CrCl <20 mL/min.
Special Precautions
Should not be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Discontinue immediately when diabetic ketoacidosis is suspected or diagnosed. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illnesses; may be restarted once patient's condition has stabilised. Discontinue in cases of recurrent UTI. Due to risk of modest BP decrease, exercise caution in patients w/ known CV disease, on diuretics, w/ history of hypotension or aged ≥75 yr. Monitoring of vol status & electrolytes are recommended. Regularly examine the feet & counsel patients on routine preventative footcare. Caution in patients at increased risk of genital infections. Positive result for glucose in urine test. For glycaemic control & risk reduction of CV death, discontinue when eGFR <30 mL/min/1.73 m2 or CrCl <30 mL/min. For heart failure, not recommended when eGFR <20 mL/min/1.73 m2. Avoid use during pregnancy & breast-feeding. Safety & effectiveness in childn <18 yr have not been established. Not recommended to initiate in patients ≥85 yr.
Adverse Reactions
Hypoglycaemia (depends on type of background therapy); UTI, vag moniliasis, vulvovaginitis, balanitis & other genital infection; increased urination, dysuria; pruritus; vol depletion; thirst; decreased GFR, increased blood creatinine, increased haematocrit, increased serum lipids.
Drug Interactions
Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Risk of hypoglycemia w/ insulin & insulin secretagogues.
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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