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 10 mg/5 mg once daily. Patient tolerating 10 mg/5 mg dose & requiring additional glycaemic control Dose may be increased to 25 mg/5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not to be used in patients w/ type 1 diabetes. Discontinue use if diabetic ketoacidosis, pancreatitis, necrotizing fasciitis & bullous pemphigoid is suspected. Immediately assess patients if symptoms of diabetic ketoacidosis occur regardless of blood glucose level. 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. Consider temporary discontinuation for at least 3 days prior to surgery in patients who undergo scheduled surgery. Consider monitoring for ketoacidosis & temporarily discontinue treatment in clinical situations known to predispose to ketoacidosis. Monitor ketones, even if treatment is interrupted. Ensure risk factors for ketoacidosis are resolved prior to restarting treatment. Evaluate patients who present w/ pain or tenderness, erythema, genital or perineal swelling, fever, malaise for necrotizing fasciitis. Concomitant use w/ sulphonylurea or insulin. Assess renal function prior to initiation of treatment & periodically during treatment, ie, at least yrly. Patients for whom an empagliflozin-induced decrease in BP could pose a risk eg, patients w/ known CV disease, on antihypertensive therapy w/ history of hypotension, or patients ≥75 yr. Carefully monitor vol status (eg, physical exam, BP measurements, lab tests including hematocrit) & electrolytes. Consider temporary interruption of therapy until fluid loss is corrected & in patients w/ complicated UTI. Not recommended in patients w/ persistent eGFR <45 mL/min/1.73 m2. Pregnancy (avoid use) & lactation (discontinue during treatment). Childn <18 yr. Increased risk of vol depletion in elderly ≥75 yr. Not recommended in childn <18 yr & elderly ≥85 yr.
Adverse Reactions
Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), perineal necrotizing fasciitis (Fournier's gangrene), nasopharyngitis; hypersensitivity, angioedema, urticaria; hypoglycaemia, ketoacidosis; increased urination, dysuria; cough; rash, pruritus, bullous pemphigoid; pancreatitis, mouth ulceration; vol depletion; thirst; decreased GFR, increased blood creatinine, lipase, amylase, hematocrit & serum lipids.
Drug Interactions
May increase risk of hypoglycemia w/ insulin & sulphonylureas. Empagliflozin: Additive diuretic effect & may increase risk of dehydration & hypotension w/ thiazide & loop diuretics. Risk of decreased efficacy w/ known uridine 5'-diphosphoglucuronosyltransferases (UGT) enzymes inducers. Linagliptin: Decreased exposure w/ strong P-glycoprotein & 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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