Posology : מינונים

4.2 Posology and method of administration
The recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
Onglyza tablets must not be split or cut.

Posology

Monotherapy and Add-On Combination Therapy
The recommended dose of Onglyza is 5 mg once daily as monotherapy or as add-on combination therapy with metformin ,a thiazolidinedione (TZD), insulin , or a sulfonylurea. Onglyza can be taken with or without food .
When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).


Initial Combination Therapy
The recommended starting doses of Onglyza and metformin when used as initial combination therapy is 5 mg Onglyza plus 500 mg metformin once daily. Patients with inadequate glycemic control on this starting dose should further have their metformin dose increased according to approved local label guidelines.

The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione, or with metformin and a sulphonylurea, has not been established.

Special populations

Renal impairment
No dosage adjustment for ONGLYZA is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment.
Because the dose of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. (see sections 5.2).

Hepatic impairment
No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).


Elderly (≥65 years)
No dose adjustment is recommended based solely on age. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function (see also sections 4.4, 5.1 and 5.2).
Paediatric population

The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established: No data are available.


Method of administration
Onglyza can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.