Glyxambi Dosage/Direction for Use

The recommended starting dose is GLYXAMBI 10 mg/5 mg (empagliflozin 10 mg / linagliptin 5 mg) once daily. In patients tolerating GLYXAMBI 10 mg/5 mg once daily and requiring additional glycaemic control, the dose can be increased to GLYXAMBI 25 mg/5 mg (empagliflozin 25 mg / linagliptin 5 mg) once daily. In patients already on empagliflozin, the dose of GLYXAMBI should provide the dose of empagliflozin similar to the dose already been taken by the patient. GLYXAMBI can be taken with or without food and at any time of day.
Combination therapy: When GLYXAMBI is used in combination with a sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see Interactions and Adverse Reactions).
Patients with renal impairment: Assess renal function prior to initiation of empagliflozin and periodically thereafter.
Glycaemic control is reduced in patients with eGFR <30 mL/min/1.73 m².
GLYXAMBI is contraindicated in patients with eGFR <30 mL/min/1.73 m².
Therapeutic experience with GLYXAMBI is limited in patients with eGFR <60 mL/min.
No dose adjustment is required for patients with eGFR ≥30 mL/min/1.73 m² (see Contraindications and Precautions).
Patients with hepatic impairment: No dose adjustment is recommended for patients with hepatic impairment.
Elderly Patients: No dosage adjustment is recommended based on age. Therapeutic experience in patients aged 75 years and older is limited. Initiation of GLYXAMBI therapy in this population is not recommended (see Precautions). Patients aged 75 years and older should be prescribed with caution (see Precautions).
Paediatric population: The safety and effectiveness of GLYXAMBI in children below 18 years of age have not been established. GLYXAMBI is not recommended for use in patients under 18 years of age.