Onglyza Tablets 2.5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SAXAGLIPTIN HYDROCHLORIDE (Anhydrous) 2.79 mg EQV SAXAGLIPTIN

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

A10BH03

Dosage:

2.5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

SAXAGLIPTIN HYDROCHLORIDE (Anhydrous) 2.79 mg EQV SAXAGLIPTIN 2.5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AstraZeneca Pharmaceuticals LP

Authorization status:

ACTIVE

Authorization date:

2010-11-25

Patient Information leaflet

ONGLYZA TABLET 

PHARMACEUTICAL FORM AND STRENGTHS 

• Each film-coated tablet contains 5.58mg saxagliptin hydrochloride (anhydrous) 
equivalent to 5mg saxagliptin. ONGLYZA 5 mg tablets are pink, biconvex, round, 
film-
coated tablets with “5” printed on one side and “4215”
printed on the reverse 
side, in blue ink. 

• Each film-coated tablet contains 2.79mg saxagliptin hydrochloride (anhydrous) 
equivalent to 2.5mg saxagliptin. ONGLYZA 2.5 mg tablets are
pale yellow to light 
yellow, biconvex, round, film-coated 
tablets with “2.5” printed on one side and 
“4214” printed on the reverse side, in blue ink. 

Each film-coated tablet of ONGLYZA contains the following inactive ingredients: 
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and 
magnesium stearate. In addition, the film coating contains the following inactive 
ingredients: polyvinyl alcohol, polyethylene glycol, titanium
dioxide, talc, and iron 
oxides.

THERAPEUTIC INDICATIONS 

ONGLYZA is indicated in adult
patients with type 2 diabetes mellitus in multiple 
clinical
settings as an adjunct to diet and exercise to improve glycaemic
control: 


  as monotherapy;  

as dual oral therapy in combination with  

  metformin as initial therapy or
when metformin alone, with diet and exercise, 
does not provide adequate glycaemic control;  


  a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does 
not provide adequate glycaemic control in patients;  


  a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, 
does not provide adequate glycaemic control in patients;  

as triple oral therapy in combination with 



metformin plus a sulphonylurea when this
regimen alone, with diet and 
exercise, does not pr

Summary of Product characteristics

ONGLYZA TABLET
PHARMACEUTICAL FORM AND STRENGTHS

Each film-coated tablet contains 5.58mg saxagliptin hydrochloride
(anhydrous)
equivalent to 5mg saxagliptin. ONGLYZA 5 mg tablets are pink,
biconvex, round,
film-coated tablets with “5” printed on one side and “4215”
printed on the reverse
side, in blue ink.

Each film-coated tablet contains 2.79mg saxagliptin hydrochloride
(anhydrous)
equivalent to 2.5mg saxagliptin. ONGLYZA 2.5 mg tablets are pale
yellow to light
yellow, biconvex, round, film-coated tablets with “2.5” printed on
one side and
“4214” printed on the reverse side, in blue ink.

Each film-coated tablet of ONGLYZA contains the following inactive
ingredients:
lactose
monohydrate,
microcrystalline
cellulose,
croscarmellose
sodium,
and
magnesium stearate. In addition, the film coating contains the
following inactive
ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide,
talc, and iron
oxides.
THERAPEUTIC INDICATIONS
ONGLYZA is indicated in adult patients with type 2 diabetes mellitus
in multiple clinical
settings as an adjunct to diet and exercise to improve glycaemic
control:
As monotherapy;
As dual oral therapy in combination with

metformin as initial therapy or when metformin alone, with diet and
exercise, does
not provide adequate glycaemic control;

a sulphonylurea, when the sulphonylurea alone, with diet and exercise,
does not
provide adequate glycaemic control in patients;

a thiazolidinedione, when the thiazolidinedione alone with diet and
exercise, does
not provide adequate glycaemic control in patients;
As triple oral therapy in combination with

metformin plus a sulphonylurea when this regimen alone, with diet and
exercise,
does not provide adequate glycaemic control

metformin plus an SGLT2 inhibitor when this regimen alone, with diet
and exercise,
does not provide adequate glycaemic control;
As combination therapy with insulin (with or without metformin), when
this regimen
alone, with diet and exercise, does not provide adequate glycae