Glyxambi

Glyxambi

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug

Marketer:

Boehringer Ingelheim
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 glycemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & linagliptin is appropriate.
Dosage/Direction for Use
Initially 10 mg/5 mg once daily, may be increased to 25 mg/5 mg once daily for patients requiring additional glycemic control.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to empagliflozin or linagliptin.
Special Precautions
Should not be used in patients w/ type 1 diabetes. Patients at risk of ketoacidosis while on treatment include patients on a very low carbohydrate diet, w/ an acute illness, pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol abuse, severe dehydration & history of ketoacidosis. Discontinue treatment if Fournier's gangrene, pancreatitis or bullous pemphigoid is suspected. Concomitant use w/ sulphonylurea or insulin. Assess renal function prior to the initiation of treatment & periodically during treatment. Patients for whom an empagliflozin-induced decrease in BP could pose a risk eg, patients w/ known CV disease, on anti-hypertensive therapy w/ history of hypotension. In conditions that may lead to fluid loss (eg, GI illness), monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes. Complicated UTI (including pyelonephritis & urosepsis). Not recommended in patients w/ renal impairment (eGFR is persistently <30 mL/min/1.73 m2). Pregnancy & lactation. Not recommended for use in childn <18 yr. Increased risk of vol depletion in elderly ≥75 yr.
Adverse Reactions
Vag moniliasis, vulvovaginitis, balanitis & other genital infections, UTI (including pyelonephritis & urosepsis), necrotizing fasciitis of the perineum (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, hematocrit & serum lipids.
Drug Interactions
May increase risk of hypoglycaemia w/ insulin & sulphonylureas. Monitoring glycemic control w/ 1,5-AG assay is not recommended as measurements, use alternative methods to monitor glycemic control. Empagliflozin: May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. May decrease blood lithium levels. Risk of decreased efficacy w/ UGT enzyme inducers. Linagliptin: Decreased exposure w/ strong P-gp or CYP450 isozyme CYP3A4 inducers.
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 (P84.82/film-coated tab)
Form
Glyxambi FC tab 25 mg/5 mg
Packing/Price
30's (P84.82/film-coated tab)
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