Steglatro

Steglatro

ertugliflozin

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ertugliflozin
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults ≥18 yr w/ type 2 DM as monotherapy in patients for whom use of metformin is considered inappropriate due to intolerance or CI, or in addition to other medicinal products for the treatment of diabetes.
Dosage/Direction for Use
Recommended starting dose: 5 mg once daily, may be increased to 15 mg once daily if needed.
Administration
May be taken with or without food: Take in the morning.
Contraindications
Special Precautions
Not to be used for type 1 DM. Discontinue use if diabetic ketoacidosis & necrotising perineum fasciitis (Fournier's gangrene) is suspected & if eGFR persistently <45 mL/min/1.73 m2 or CrCl persistently <45 mL/min. Not to be initiated in patients w/ eGFR <60 mL/min/1.73 m2 or CrCl <60 mL/min. Vol depletion risk in patients on diuretics, antihypertensives or w/ history of hypotension. Patients w/ low β-cell function reserve, conditions that lead 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). False positive result for glucose test. Interference w/ 1,5-anhydroglucitol assay. Concomitant use w/ insulin & insulin secretagogues. Monitor renal function prior to & during treatment. Monitor vol status & electrolytes during therapy. Counsel patients on routine preventative foot care. Galactose intolerance, total lactase deficiency, glucose-galactose malabsorption. May affect ability to drive & use machines. Not to be used in severe renal impairment, end-stage renal disease or receiving dialysis. Not recommended in severe hepatic impairment. Not to be used during pregnancy & lactation. Childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Vulvovag & other female genital mycotic infections. Balanitis candida & other male genital mycotic infections; hypoglycaemia; vol depletion; increased urination; vulvovag pruritus; thirst; changed serum lipids, increased Hb & BUN.
Drug Interactions
Increased risk of dehydration & hypotension w/ diuretics. Increased risk of hypoglycaemia w/ insulin &/or insulin secretagogues eg, sulphonylureas.
MIMS Class
ATC Classification
A10BK04 - ertugliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Steglatro FC tab 5 mg
Packing/Price
28's
Form
Steglatro FC tab 15 mg
Packing/Price
28's
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