Glyxambi

Glyxambi

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 10 mg/5 mg FC tab Empagliflozin 10 mg, linagliptin 5 mg. Per 25 mg/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.
Dosage/Direction for Use
Initially empagliflozin 10 mg/linagliptin 5 mg once daily. Patient tolerating 10 mg/5 mg dose & requiring additional glycaemic control Dose may be increased to empagliflozin 25 mg/linagliptin 5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients on dialysis.
Special Precautions
Discontinue use if diabetic ketoacidosis, necrotizing fasciitis, pancreatitis or bullous pemphigoid is suspected. Consider temporary discontinuation for at least 3 days prior to surgery in patients who undergo scheduled surgery. Temporary interruption of treatment until fluid loss is corrected; in patients w/ complicated UTI. Not to be used in patients w/ type 1 diabetes; ketoacidosis; severe infection or accident. Bacterial & fungus infection on genital area & urinary tract. Increased risk of severe joint pain. Patients w/ very low carbohydrate diet, acute illness, pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including pump failure), alcohol abuse, severe dehydration, & history of ketoacidosis; known CV disease, on antihypertensive therapy w/ history of hypotension, or patients ≥75 yr for whom an empagliflozin-induced decrease in BP could pose a risk. Immediately assess patients if symptoms of ketoacidosis occur regardless of blood glucose level. Consider monitoring for ketoacidosis & temporarily discontinue treatment in clinical situations known to predispose to ketoacidosis. Monitor ketones; vol status & electrolytes. Evaluate patients who present w/ pain or tenderness, erythema, genital or perineal swelling, fever, malaise for necrotizing fasciitis. Assess renal function prior to initiation of treatment & periodically during treatment, ie, at least yrly. Concomitant use w/ sulphonylurea or insulin. Not to be taken w/ alcohol beverage. Not recommended in patients w/ persistent estimated GFR <30 mL/min/1.73 m2. Avoid use during pregnancy. Discontinue breastfeeding during treatment. Not recommended in childn <18 yr & elderly ≥85 yr. Elderly ≥75 yr (increased risk of vol depletion).
Adverse Reactions
Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), perineal necrotizing fasciitis (Fournier's gangrene), nasopharyngitis; hypersensitivity, angioedema, urticaria; hypoglycaemia (when used w/ sulphonylurea or insulin), ketoacidosis; increased urination, dysuria; cough; rash, pruritus, bullous pemphigoid; constipation, pancreatitis, mouth ulceration; vol depletion; thirst; decreased GFR, increased blood creatinine, lipase, amylase, haematocrit & serum lipids.
Drug Interactions
Increased risk of hypoglycaemia w/ insulin & sulphonylureas. Interference w/ 1,5-anhydroglucitol assay. Empagliflozin: Additive diuretic effect & increased risk of dehydration & hypotension of thiazide & loop diuretics. Decreased blood lithium levels. Decreased efficacy w/ uridine 5'-diphospho-glucuronosyltransferases enzyme inducers. Linagliptin: Decreased exposure w/ strong P-gp & CYP3A4 inducers (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
3 × 10's
Form
Glyxambi FC tab 25 mg/5 mg
Packing/Price
3 × 10's
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