Glyxambi

Glyxambi

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
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 glycemic control in adults w/ type 2 DM when treatment w/ both empagliflozin &/or linagliptin ± metformin do not provide adequate glycaemic control.
Dosage/Direction for Use
10/5 mg once daily, may be increased to 25/5 mg once daily when tolerated.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Hypersensitivity to empagliflozin, linagliptin, other Na-glucose-co-transporter-2 (SGLT2) or other dipeptidyl-peptidase-4 (DPP-4) inhibitor. Patients w/ CKD stage 4 or 5 [severe renal impairment eg, patients receiving dialysis; eGFR <30 mL/min/1.73 m2 or CrCl <30 mL/min)] or eGFR persistently <45 mL/min/1.73 m2 or CrCl persistently <45 mL/min (CKD stage 3B).
Special Precautions
Not to be used in type 1 diabetes or diabetic ketoacidosis. Discontinue use if necrotizing infection, Fournier's gangrene, pancreatitis, bullous pemphigoid are suspected. Patients w/ low β-cell function reserve; conditions that lead to restricted food intake or severe dehydration; reduced insulin doses; w/ increased insulin requirements due to acute medical illness, surgery or alcohol abuse. Vol-depletion risk in patients w/ CV disease, on antihypertensive therapy w/ history of hypotension or ≥75 yr; conditions leading to fluid loss eg, GI illness; cardiac failure (NYHA I-IV); complicated UTI; +ve glucose urine test; elevated hematocrit. Assess renal function prior to & periodically during treatment. Monitor ketones in patients hospitalised for major surgery or acute serious medical illnesses. Interference w/ 1,5-anhydroglucitol assay. Counsel patients on routine preventative foot-care. Concomitant use w/ sulphonylureas &/or insulin. May affect ability to drive & use machines. Not to be initiated if eGFR persistently <45 mL/min/1.73 m2 or CrCl persistently <45 mL/min. Not to be used in patients w/ end-stage renal disease or on dialysis. Not recommended in severe hepatic impairment. Hepatic injury. Avoid use during pregnancy. Not to be used during lactation. Paed patients <18 yr. Not recommended in elderly ≥85 yr.
Adverse Reactions
UTI eg, pyelonephritis & urosepsis, vag moniliasis, vulvovaginitis, balanitis, other genital infections, nasopharyngitis; hypoglycaemia, thirst; cough; pruritus, rash; increased urination; increased amylase & lipase.
Drug Interactions
Increased risk of hypoglycaemia w/ insulin & sulphonylureas. Empagliflozin: Increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Decreased efficacy by UGT inducers. Linagliptin: Reduced efficacy w/ strong P-glycoprotein or CYP450 inducers.
MIMS Class
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 25 mg/5 mg FC tab
Packing/Price
30's
Form
Glyxambi 10 mg/5 mg FC tab
Packing/Price
30's
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