Glyxambi

Glyxambi Dosage/Direction for Use

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Dosage/Direction for Use
Posology: The recommended starting dose is 1 film-coated tablet of GLYXAMBI 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily.
In patients who tolerate this starting dose and require additional glycaemic control, the dose can be increased to 1 film-coated tablet of GLYXAMBI 25 mg/5 mg (25 mg empagliflozin plus 5 mg linagliptin) once daily.
When GLYXAMBI is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see Precautions, Interactions and Adverse Reactions).
Patients switching from empagliflozin (either 10 mg or 25 mg daily dose) and linagliptin (5 mg daily dose) to GLYXAMBI should receive the same daily dose of empagliflozin and linagliptin in the fixed dose combination as in separate tablets. The metformin dose should be continued.
Special populations: Renal impairment: Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin (see Precautions and Pharmacology: Pharmacodynamics under Actions).
In patients with an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 or creatinine clearance (CrCl) ≥45 mL/min, no dose adjustment is required.
In patients with an eGFR persistently below <45 mL/min/1.73 m2 or CrCl <45 mL/min, GLYXAMBI should not be initiated.
When eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min, treatment should be discontinued (see Precautions, Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
In patients with end-stage renal disease or in patients on dialysis, GLYXAMBI should not be used as empagliflozin is not expected to be effective in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment.
Empagliflozin exposure is increased in patients with severe hepatic impairment and therapeutic experience in such patients is limited (see Pharmacology: Pharmacokinetics under Actions). Therefore, GLYXAMBI is not recommended for use in this population.
Elderly: No dosage adjustment based on age is required. However, renal function and risk of volume depletion should be taken into account in elderly patients (see Precautions and Adverse Reactions). Based on very limited experience in patients 75 years and older, initiation of GLYXAMBI therapy is not recommended in this population (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Safety and efficacy of GLYXAMBI in paediatric patients below 18 years of age have not been established. No data are available.
Method of administration: GLYXAMBI tablets are for oral use and can be taken with or without a meal at any time of the day at regular intervals. The tablets should be swallowed whole with water. If a dose is missed, and it is 12 hours or more until the next dose, the dose should be taken as soon as the patient remembers. The next dose should be taken at the usual time. If a dose is missed, and it is less than 12 hours until the next dose, the dose should be skipped and the next dose should be taken at the usual time. A double dose should not be taken to compensate for a forgotten dose.
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