Glycenor M

Indication

This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
? In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
? In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
? In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.

Dosage & Administration

? Individualize the starting dose is based on the patient’s current regimen:
− In patients on Metformin Hydrochloride, switch to this tablet containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride;
− In patients on Empagliflozin, switch to this tablet containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin;
− In patients already treated with Empagliflozin and Metformin Hydrochloride, switch to tablet containing the same total daily doses of each component.
? Take this tablet twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to Metformin.
? Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of Metformin Hydrochloride 2000 mg and Empagliflozin 25 mg.

Precautions

Lactic Acidosis: Lactic acidosis, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis.

Diabetic ketoacidosis (DKA): Have been reported in patients treated with SGLT2 inhibitors, including Empagliflozin.

Renal function: GFR should be assessed before treatment initiation and regularly thereafter. This tablet is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.

Cardiac function: Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, this tablet may be used with a regular monitoring of cardiac and renal function. For patients with acute and unstable

heart failure, this tablet is contraindicated due to the Metformin component.

Surgery: Metformin must be discontinued at the time of surgery under general, spinal or epidural anesthesia. Therapy may be restarted after 48 hours of surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.

Hypotension: Caution should be exercised in patients for whom a Empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older.

Elderly: Patients aged 75 years and older may be at an increased risk of volume depletion. Initiation of therapy in patients aged 85 years and older is not recommended due to limited experience.

Urinary tract infections: Temporary interruption of treatment should be considered in patients with complicated urinary tract infections.

Hepatic injury: Cases of hepatic injury have been reported with Empagliflozin in clinical trials. A causal relationship between Empagliflozin and hepatic injury has not been established.

Use in Pregnancy & Lactation

Pregnancy: Advise females of the potential risk to a fetus especially during the second

and third trimesters

Lactation: This combination is not recommended when breastfeeding.