Steglujan

Steglujan

ertugliflozin + sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ertugliflozin 15 mg, sitagliptin 100 mg
Indications/Uses
Type 2 DM in adults ≥18 yr as an adjunct to diet & exercise to improve glycaemic control when metformin &/or a sulphonylurea & 1 of the monocomponents of Steglujan do not provide adequate glycaemic control; in patients already being treated w/ the combination of ertugliflozin & sitagliptin as separate tab.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Special Precautions
Should not be used in patients w/ type 1 DM. Risk of developing acute pancreatitis; symptomatic hypotension, particularly in patients w/ impaired renal function, elderly patients, patients on diuretics, or patients on antihypertensive therapy w/ history of hypotension; serious hypersensitivity reactions; bullous pemphigoid. Rare cases of diabetic ketoacidosis. Increase in cases of lower limb amputation (primarily of the toe). Should not be initiated in patients w/ eGFR <60 mL/min/1.73 m2 or CrCl <60 mL/min. Discontinue when eGFR is persistently <45 mL/min/1.73 m2 or CrCl persistently <45 mL/min. Increased risk of hypoglycaemia when used in combination w/ insulin &/or insulin secretagogue; genital mycotic infections; UTI; vol depletion in elderly patients. Patients w/ cardiac failure. Positive results for glucose in the urine. Not recommended to use 1,5-AG assay in monitoring glycaemic control. Should not be used during pregnancy & breast-feeding.
Adverse Reactions
Vulvovaginal mycotic infection & other female genital mycotic infections. Balanitis candida & other male genital mycotic infections, hypoglycaemia, headache, vol depletion, increased urination, vulvovaginal pruritus, thirst, serum lipids changed, Hb increased, BUN increased.
Drug Interactions
Ertugliflozin: May add to the diuretic effect of diuretics & may increase risk of dehydration & hypotension. Increased risk of hypoglycaemia w/ insulin &/or insulin secretagogue. Sitagliptin: Potential alteration in pharmacokinetics w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, clarithromycin) in patients w/ severe renal impairment of ESRD. Monitor for digoxin toxicity when sitagliptin & digoxin are co-administered.
MIMS Class
ATC Classification
A10BD24 - sitagliptin and ertugliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Steglujan 15/100 mg FC tab
Packing/Price
28's
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