Glyxambi佳糖達

Glyxambi

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Per 10/5 mg FC tab Empagliflozin 10 mg, linagliptin 5 mg. Per 25/5 mg FC tab Empagliflozin 25 mg, linagliptin 5 mg
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & linagliptin is appropriate.
Dosage/Direction for Use
Start w/ 10/5 mg once daily, can be increased to 25/5 mg once daily if additional glycaemic control is required.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m2), ESRD & patients on dialysis.
Special Precautions
Not for use in patients w/ type 1 diabetes. Caution in patients at higher risk of diabetic ketoacidosis (DKA). Discontinue use in patients w/ suspected or diagnosed DKA; suspected pancreatitis; suspected bullous pemphigoid. Interrupt treatment for major surgical procedures or in acute serious medical illnesses. Monitoring of ketone levels (blood test is preferred to urine test) is recommended in these patients. Treatment w/ empagliflozin may be restarted when ketone values are normal & patient's condition has stabilized. Caution when used in combination w/ a sulfonylurea &/or insulin; dose reduction of sulfonylurea or insulin may be considered. Caution in patients for whom an empagliflozin-induced drop in BP & vol depletion could pose a risk. Carefully monitor vol status & electrolytes. Temporarily interrupt treatment until fluid loss is corrected. Treatment w/ SGLT2 inhibitors increases the risk for UTI; evaluate patients for signs & symptoms of UTI & treat promptly if indicated. Consider discontinuation in cases of recurrent UTI. Regularly examine the feet & counsel all patients on routine preventative footcare. Patients w/ suspected Fournier's Gangrene should immediately start treatment w/ broad-spectrum antibiotics &, if necessary, surgical debridement; discontinue empagliflozin, closely monitor blood glucose levels, & provide appropriate alternative therapy. Consider discontinuation in patients who present w/ or experience an exacerbation of arthralgia during treatment w/ linagliptin. Linagliptin has not been studied in combination w/ GLP-1 analogues. Assess renal function prior to treatment initiation & periodically during treatment; & prior to initiation of concomitant medicines that may reduce renal function & periodically thereafter. Patients treated w/ empagliflozin can experience an initial fall in eGFR. Avoid use during pregnancy & breast-feeding. Not recommended in patients <18 yr. Not recommended to initiate in patients ≥75 yr.
Adverse Reactions
Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI, nasopharyngitis; hypoglycaemia (when used w/ sulfonylurea or insulin); increased urination; cough; constipation; arthralgia; increased lipase, increased serum lipids. 10/5 mg: Rash, increased amylase. 25/5 mg: Pruritus.
Drug Interactions
Increased risk of hypoglycaemia w/ insulin & sulfonylureas. Empagliflozin: May add to diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. May increase renal lithium excretion & decrease blood lithium levels. Linagliptin: Decreased steady-state AUC & Cmax w/ rifampicin.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD19 - linagliptin and empagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Glyxambi FC tab 10 mg/5 mg
Packing/Price
30's
Form
Glyxambi FC tab 25 mg/5 mg
Packing/Price
30's
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