Jardiance Duo迅糖達

Jardiance Duo

empagliflozin + metformin

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Per 5/500 mg FC tab Empagliflozin 5 mg, metformin HCl 500 mg. Per 12.5/500 mg FC tab Empagliflozin 12.5 mg, metformin HCl 500 mg. Per 5/1,000 mg FC tab Empagliflozin 5 mg, metformin HCl 1,000 mg. Per 12.5/1,000 mg FC tab Empagliflozin 12.5 mg, metformin HCl 1,000 mg
Indications/Uses
Adjunct to diet & exercise in adults w/ type 2 DM insufficiently controlled on metformin alone; in combination w/ other medicinal products for the treatment of diabetes in patients insufficiently controlled w/ metformin & these medicinal products; in patients already treated w/ empagliflozin & metformin as separate tab.
Dosage/Direction for Use
Patient w/ normal renal function (GFR ≥90 mL/min) 1 tab bd. Patient insufficiently controlled on metformin alone or in combination w/ other medicinal products for the treatment of DM 5 mg bd w/ the dose of metformin already being taken. Patient who need tighter glycaemic control Total daily dose of empagliflozin can be increased to 25 mg. Patient in combination w/ a sulphonylurea &/or insulin Lower dose of sulphonylurea &/or insulin may be required to reduce the risk of hypoglycemia. Patient switching from separate tab of empagliflozin & metformin Same daily dose of empagliflozin & metformin already being taken.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Any type of acute metabolic acidosis. Diabetic pre-coma. Acute conditions w/ the potential to alter renal function eg, dehydration, severe infection, shock. Disease which may cause tissue hypoxia (especially acute disease or worsening of chronic disease). Acute alcohol intoxication. Alcoholism. Acute & unstable heart failure. Severe renal failure (GFR <30 mL/min). Hepatic impairment.
Special Precautions
Should not be used in patients w/ type 1 diabetes. Discontinue use in patients w/ suspected or diagnosed diabetic ketoacidosis (DKA) or lactic acidosis. Caution in patients at higher risk of DKA; do not restart in patients w/ previous DKA. Recommended to monitor ketones (blood ketone levels is preferred to urine) in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Temporarily discontinue in case of dehydration, complicated UTI, acute serious medical illnesses or w/ conditions that alter renal function. Caution in medicinal products that can acutely impair renal function. Assess GFR before treatment initiation & regularly thereafter. Regular monitoring of cardiac & renal function in patients w/ stable chronic heart failure. Discontinue prior to or at the time of imaging procedure or major surgical procedures; do not restart until ≥48 hr after imaging procedure or surgery or resumption of oral nutrition, provided w/ a stable renal function. Caution in patients w/ known CV disease, on anti-hypertensive therapy w/ a history of hypotension or age ≥75 yr. Caution w/ co-administered medicinal products which may lead to vol depletion in patients ≥75 yr. Cases of lower limb amputation have been observed; counsel patients on routine preventative footcare. Patients w/ suspected Fournier's Gangrene should immediately start treatment w/ broad-spectrum antibiotics &, if necessary, surgical debridement; discontinue Jardiance Duo, closely monitor blood glucose levels, & provide appropriate alternative therapy. Increased haematocrit level w/ empagliflozin. Positive result for glucose in urine test while taking empagliflozin. Should not be initiated in patients w/ GFR <60 mL/min. Not recommended in patients w/ GFR <45 mL/min. Not recommended during pregnancy. Should not be used during breast-feeding. Not recommended in patients ≥85 yr or <18 yr.
Adverse Reactions
Hypoglycaemia (when used w/ sulphonylurea or insulin), GI symptoms. Vag moniliasis, vulvovaginitis, balanitis & other genital infection, UTI (including pyelonephritis & urosepsis), thirst, taste disturbance, pruritus (generalised), rash, increased urination, increased serum lipids.
Drug Interactions
Empagliflozin: Additive diuretic effect w/ thiazide & loop diuretics. Increased risk of hypoglycaemia w/ insulin & insulin secretagogues. Potential risk of decreased efficacy w/ known UGT enzyme inducers. Metformin: Not recommended w/ alcohol, organic cation transporters, iodinated contrasting agents. Use w/ precaution w/ NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics, glucocorticoids, β2-agonists, insulin, insulin secretagogues.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD20 - metformin and empagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Jardiance Duo FC tab 12.5 mg/1000 mg
Packing/Price
60's
Form
Jardiance Duo FC tab 12.5 mg/500 mg
Packing/Price
60's
Form
Jardiance Duo FC tab 5 mg/1000 mg
Packing/Price
60's
Form
Jardiance Duo FC tab 5 mg/500 mg
Packing/Price
60's
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