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 heart failure independent of left ventricular ejection fraction in adults, as an adjunct to standard of care therapy. Risk reduction of kidney disease progression in adults w/ CKD.
Dosage/Direction for Use
Type 2 DM 10 mg once daily, can be increased to 25 mg once daily if additional glycaemic control is required in patients w/ an eGFR ≥30 mL/min/1.73 m2. Heart failure 10 mg once daily. CKD 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Should not be used in patients w/ type 1 diabetes or for treatment of ketoacidosis. Discontinue immediately when ketoacidosis is suspected or diagnosed. Reports of ketoacidosis cases in patients w/o DM. 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 is recommended. Regularly examine the feet & counsel patients on routine preventative footcare. Caution in patients at increased risk of genital infections. +ve result for glucose in urine test. Not recommended when eGFR <20 mL/min/1.73 m2 or on dialysis. Avoid use during pregnancy & breast-feeding. Safety & effectiveness in childn <18 yr have not been established. Initiation of treatment for type 2 DM is not recommended in patients ≥85 yr.
Adverse Reactions
Hypoglycaemia (depends on type of background therapy); UTI, vag moniliasis, vulvovaginitis, balanitis & other genital infection; increased urination, dysuria; constipation; pruritus; vol depletion; thirst; decreased GFR, increased blood creatinine, increased haematocrit, increased serum lipids. Post-marketing experience: Ketoacidosis, pyelonephritis, urosepsis, necrotising fasciitis of the perineum (Fournier's gangrene), allergic skin reaction, angioedema, phimosis.
Drug Interactions
Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Risk of hypoglycemia w/ insulin or insulin secretagogues. Increased renal excretion & decreased blood levels of lithium. Monitor lithium serum conc more frequently after empagliflozin initiation & dose changes.
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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