Steglujan

Per 5 mg/100 mg FC tab Ertugliflozin 5 mg, sitagliptin 100 mg. Per 15 mg/100 mg FC tab Ertugliflozin 15 mg, sitagliptin 100 mg

Type 2 DM in adults ≥18 yr as adjunct to diet & exercise to improve glycaemic control when metformin & 1 of monocomponents of Steglujan do not provide adequate glycaemic control; in patients already being treated w/ combination of ertugliflozin & sitagliptin as separate tab.

Initially 5 mg/100 mg tab once daily, may be increased to 15 mg/100 mg once daily.

May be taken with or without food: Take tab in the morning. For patients w/ swallowing difficulties, tab may be broken/crushed.

Hypersensitivity.

Discontinue use if hypersensitivity, pancreatitis, diabetic ketoacidosis, Fournier's gangrene or bullous pemphigoid is suspected; eGFR persistently <45 mL/min/1.73 m² or CrCl persistently <45 mL/min. Not to be used for type 1 DM. Vol depletion risk in patients on diuretics, antihypertensives or w/ history of hypotension. Patients w/ low β-cell function reserve, conditions leading to restricted food intake or severe dehydration, increased/decreased insulin dose due to acute medical illness, surgery or alcohol abuse; events which may precede amputation eg, lower-extremity skin ulcer, infection, osteomyelitis or gangrene. Increased risk of genital mycotic infections; UTI; cardiac failure (NYHA class I-IV); severe & disabling arthralgia. Monitor vol status & electrolytes during therapy in conditions leading to fluid loss eg, GI illness. Assess renal function prior to & during treatment. Ensure adequate hydration. Counsel patients on routine preventative foot care. Concomitant use w/ insulin & insulin secretagogues. False +ve result for glucose urine test. Interference w/ 1,5-anhydroglucitol assay. May affect ability to drive & use machines. Not to be used in severe renal impairment, ESRD or receiving dialysis. Not recommended in patients w/ eGFR <60 mL/min/1.73 m² or CrCl <60 mL/min; severe hepatic impairment. Not to be used during pregnancy & lactation. Childn <18 yr. Elderly ≥65 yr.

Vulvovag & other female genital mycotic infections. Balanitis candida & other male genital mycotic infections; hypoglycaemia; increased urination; vol depletion; vulvovag pruritus; thirst; changed serum lipids, increased Hb & BUN.

Ertugliflozin: Additive effect, increased risk of dehydration & hypotension w/ diuretics. Increased risk of hypoglycaemia w/ insulin &/or insulin secretagogue. Decreased AUC & C_max by rifampin. Increased AUC & C_max of simvastatin. Sitagliptin: Increased AUC & C_max of digoxin. Increased AUC & C_max w/ oral cyclosporine.

Antidiabetic Agents

A10BD24 - sitagliptin and ertugliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

B