Empacoza Plus 25/5 mg 30 tablets

Empacoza Plus 5 mg/25 mg 30 Tablets

Composition

Each film-coated tablet contains:

Empacoza Plus 5/25 mg: Empagliflozin 25 mg and Linagliptin 5 mg

Description

Empacoza Plus is a fixed-dose combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated for adults with type 2 diabetes mellitus. It works by promoting urinary glucose excretion and enhancing incretin activity to improve blood glucose control. Empacoza Plus is intended for patients whose blood sugar levels are not adequately controlled with metformin and/or sulphonylurea and one of the individual components.

Indications for Use

Adults (≥18 years) with type 2 diabetes mellitus:

Inadequate glycemic control on metformin and/or sulphonylurea and one of the components of Empacoza Plus

Patients already treated with the free combination of empagliflozin and linagliptin

Dosage and Method of Administration

Starting dose: One tablet of 10 mg empagliflozin / 5 mg linagliptin once daily

If needed for better glycemic control: Increase to one tablet of 25 mg empagliflozin / 5 mg linagliptin once daily

Renal impairment: Do not initiate if eGFR or CrCl <60 mL/min; reduce dose or discontinue if eGFR or CrCl persistently <45 mL/min

Hepatic impairment: Not recommended in severe cases

Elderly: Use caution in patients ≥75 years old; not recommended for ≥85 years old

Contraindications

Hypersensitivity to empagliflozin, linagliptin, or any excipients

Type 1 diabetes mellitus

Diabetic ketoacidosis

End-stage renal disease or patients on dialysis

Precautions

Risk of diabetic ketoacidosis with atypical presentation

Monitor renal function regularly

Increased risk of hypoglycemia with insulin or sulphonylurea

Risk of acute pancreatitis, particularly in patients with history of pancreatitis

Monitor volume status in case of dehydration risk

Risk of urinary/genital infections

Possible hepatic injury or elevated hematocrit

Not recommended in patients aged ≥85 years

Pregnancy and Breastfeeding

Not recommended during pregnancy and breastfeeding due to lack of data

Side Effects

Very common: Urinary tract infections (7.5–8.5%)

Serious: Diabetic ketoacidosis (<0.1%), pancreatitis (0.2%), hypersensitivity (0.6%), hypoglycemia (2.4%)

Others: Genital infections, volume depletion, rash, hepatic enzyme elevations

Storage Conditions

Store below 30°C. Keep out of reach of children.

Packaging

Carton box contains 3 blisters of 10 film-coated tablets and a package insert.