Dosage & Administration
Dapaglin® can be used as:
Type 2 diabetes mellitus
- The recommended dose is 10 mg dapagliflozin once daily.
When dapagliflozin is used in combination with insulin or an insulin
secretagogue, such as asulphonylurea, a lower dose of insulin or insulin
secretagogue may be considered to reduce the risk of hypoglycaemia
Type 1 diabetes mellitus
- The recommended dose is 5 mg once daily.
- Dapagliflozin must only be administered as an adjunct to insulin.
- Heart failure
- The recommended dose is 10 mg dapagliflozin once daily.
Treatment of diabetes mellitus in patients with renal impairment
As glycaemic efficacy is dependent on renal function, Dapaglin® should not be
initiated to improve glycaemic control in patients with a glomerular filtration
rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below
45 mL/min .
No dose adjustment is required based on renal function.
Treatment of heart failure in patients with renal impairment
No dose adjustment is required based on renal function .
There is limited experience with dapagliflozin for the treatment of heart failure
in patients with severe renal impairment (GFR < 30 mL/min).
- Hepatic impairment
No dose adjustment is necessary for patients with mild or moderate hepatic
impairment. In patients with severe hepatic impairment, a starting dose of 5 mg
is recommended. If well tolerated, the dose may be increased to 10 mg when
indicated.
- Patients with type 1 diabetes mellitus
Dapaglin® 10 mg is not recommended for the treatment of heart failure in
patients with type 1 diabetes mellitus .
- Elderly (≥ 65 years)
No dose adjustment is recommended based on age.
- Paediatric population
The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not
yet been established.No data are available.
Dapaglin® can be taken orally once daily at any time of day with or without
food. Tablets are to be swallowed whole.
Overdose:
Dapagliflozin did not show any toxicity in healthy subjects at single oral doses
up to 500 mg (50 times the maximum recommended human dose).
In the event of an overdose, appropriate supportive treatment should be initiated
as dictated by the patient’s clinical status. The removal of dapagliflozin by
haemodialysis has not been studied.