Steglatro

Steglatro

ertugliflozin

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Ertugliflozin
Indications/Uses
As an adjunct to diet & exercise to improve glycaemic control in adults ≥18 yr w/ type 2 DM: As monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications; or in addition to other medicinal products for the treatment of diabetes.
Dosage/Direction for Use
Recommended starting dose: 5 mg once daily. Can be increased to 15 mg once daily if necessary.
Administration
May be taken with or without food: Take in the morning.
Contraindications
Special Precautions
Should not be used in patients w/ type 1 DM. Risk of hypotension/vol depletion. Assess & correct vol status before initiating therapy; monitor for signs & symptoms of symptomatic hypotension after initiating therapy. Risk of diabetic ketoacidosis. Reports of increased cases of lower limb amputation (primarily of the toe) in long-term clinical studies w/ another SGLT2 inhibitor. Assess renal function prior to treatment initiation & periodically thereafter. Initiation of treatment is not recommended in patients w/ eGFR <60 mL/min/1.73 m2 or CrCl <60 mL/min. Discontinue if eGFR is persistently <45 mL/min/1.73 m2 or CrCl is persistently <45 mL/min. Increased risk of genital mycotic infections; UTIs. Patients w/ cardiac failure. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. False positive result for glucose in urine laboratory assessments. Monitoring glycaemic control w/ 1,5-AG assay is not recommended. Concomitant use w/ insulin & insulin secretagogues. Should not be used in patients w/ severe renal impairment, w/ end-stage renal disease, or receiving dialysis. Not recommended in patients w/ severe hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Vulvovaginal mycotic infection & other female genital mycotic infections. Balanitis candida & other male genital mycotic infections; hypoglycaemia; vol depletion; increased urination; vulvovaginal pruritus; thirst; serum lipids changed, Hb increased, BUN increased.
Drug Interactions
Increased risk of dehydration & hypotension w/ diuretics. Increased risk of hypoglycaemia w/ insulin &/or an insulin secretagogue.
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 15 mg
Packing/Price
28's
Form
Steglatro FC tab 5 mg
Packing/Price
28's
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