Dosage

DOSE RECOMMENDATION FOR JARDIANCE® (EMPAGLIFLOZIN) A SGLT2 INHIBITOR FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS1

Jardiance® is a sodium-glucose co-transporter 2 inhibitor that works independently of β-cell function and insulin resistance1.

CONSIDERATIONS BEFORE INITIATING TREATMENT OF TYPE 2 DIABETES MELLITUS WITH JARDIANCE1

  • The patient must be assessed for hydration and renal function;
  • Treatment must not be started;
    • if the patient is acidotic;
    • if the patient is volume-depleted;
    • in patients with eGFR < ml / min/1,73 m2 or creatinine clearance is < 60 ml / min;
    • in elderly patients aged 85 or older.

DOSAGE RECOMMENDATION FOR JARDIANCE® (EMPAGLIFLOZIN)

Jardiance® is a convenient once daily tablet which can be taken at any time of the day and with or without food1.

The recommended starting dose, for the treatment of type 2 diabetes, is Jardiance® 10 mg once-daily. This can be increased to Jardiance® 25 mg once-daily if additional glycaemic control is required1.

Jardiance

When a patient misses a dose of Jardiance®, it should be taken as soon as possible after the missed dose time. The patient must not have taken a double dose on the same day 1.

DOSAGE OF JARDIANCE® IN PATIENTS TAKING CONCOMITANT MEDICATION1

Jardiance® can be used alone or in combination with other common therapies1.

For patients on insulin or insulin secretagogue (e.g. sulphonylurea), a lower dose of these agents may be needed to reduce the risk of hypoglycaemia when used in combination with Jardiance®1.

There are no clinically meaningful drug-drug interactions which were observed when Jardiance® was co-administered with other commonly used medications 1.

Jardiance® did not effect the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, digoxin, ramipril, simvastatin, hydrochlorothiazide, torasemide and oral contraceptives when co-administered in healthy volunteers 1.

DOSAGE CONSIDERATIONS IN SPECIFIC PATIENT GROUPS1

Renal InsufficiencyPatients with mild renal insufficiency with eGFR ≥ 60 to < 90 mL / min / 1,73 m2Dose does not need to be adjusted
Renal function to be assessed before treatment started and at least 6 monthly thereafter
Patients with moderate to severe renal insufficiency with eGFR < 60 mL / min / 1,73 m2Jardiance® not recommended
Hepatic InsufficiencyDose adjustment may be necessary for patients with severe hepatic impairment
Elderly PatientsWhen creatinine clearance is ≥ 60 mL / min, no dose adjustment is required
Paediatric PatientsThe safety and efficacy of Jardiance® in patients under 18 years of age have not been established

JARDIANCE® INDICATIONS1

Jardiance® tablets are indicated for adults with type 2 diabetes mellitus:

  • As an adjunct to diet and exercise to improve glycaemic control in adults1,
  • In combination with glucose-lowering medicines, including metformin, athiazolidinedione, a Sulphonylurea, a DPP4 inhibitor, or insulin, when these togetherwith diet and exercise, do not provide adequate glycaemic control1.

REFERENCES:

  1. Jardiance® approved package insert. Date of publication 12 December 2017

S4 JARDIANCE® 10 mg: Each film-coated tablet contains empagliflozin 10 mg. Reg. No. 48/21.2/1380.
S4 JARDIANCE® 25 mg: Each film-coated tablet contains empagliflozin 25 mg. Reg. No. 48/21.2/0411.
For full prescribing information refer to the package insert approved by the Medicines Regulatory Authority.
BI Ref. No. PC-ZA-100360. Exp: June 2021