KOMBIGLYZE XR TABLET 5MG500MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Metformin Hydrochloride + 0.5% Magnesium Stearate; Saxagliptin hydrochloride anhydrous 5.58mg eqv saxagliptin

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

A10BD10

Dosage:

500mg

Pharmaceutical form:

TABLET, FILM COATED, EXTENDED RELEASE

Composition:

Metformin Hydrochloride + 0.5% Magnesium Stearate 500mg; Saxagliptin hydrochloride anhydrous 5.58mg eqv saxagliptin 5.0mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AstraZeneca Pharmaceuticals LP

Authorization status:

ACTIVE

Authorization date:

2012-02-29

Patient Information leaflet

Page 1 of 47 

KOMBIGLYZE XR TABLET 
PHARMACEUTICAL FORMS AND STRENGTHS 

  KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/500 mg tablets 
are light brown to brown, biconvex, capsule-shaped, film-coated tablets with “5/500” printed 
on one side and “4221” printed on the reverse side, in
blue ink. 

  KOMBIGLYZE  XR  (saxagliptin  and  metformin  HCl  extended-release)  5  mg/1000  mg 
tablets are pink, biconvex, capsule-shaped, film-coated tablets with “5/1000” printed on one 
side and “4223” printed on the reverse side, in blue ink. 

  KOMBIGLYZE  XR  (saxagliptin  and  metformin  HCl  extended-release)  2.5  mg/1000  mg 
tablets  are  pale  yellow  to  light  yellow,  biconvex,  capsule-shaped,  film-coated  tablets  with 
“2.5/1000” printed on one side and “4222” printed on the
reverse side, in blue ink. 
THERAPEUTIC INDICATIONS 
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control 
in  adults  with  type  2  diabetes  mellitus  when  treatment  with  both  saxagliptin  and  metformin  is 
appropriate. [See _Clinical Studies_] 
IMPORTANT LIMITATIONS OF USE 
KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes mellitus or diabetic 
ketoacidosis. 
KOMBIGLYZE XR has not been studied in patients with a history of pancreatitis. It is unknown 
whether  patients  with  a  history  of  pancreatitis  are  at  an  increased  risk  for  the  development  of 
pancreatitis while using KOMBIGLYZE XR. [See _Special Warnings
and Precautions for Use_] 

POSOLOGY AND METHOD OF ADMINISTRATION 
RECOMMENDED DOSAGE 
The dosage of KOMBIGLYZE XR should be individualized on the basis of the patient’s current 
regimen,  effectiveness,  and  tole

Summary of Product characteristics

Page
1
of
61
KOMBIGLYZE XR TABLET
PHARMACEUTICAL FORMS AND STRENGTHS

KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5
mg/500 mg
tablets are light brown to brown, biconvex, capsule-shaped,
film-coated tablets with
“5/500” printed on one side and “4221” printed on the reverse
side, in blue ink.

KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5
mg/1000 mg
tablets are pink, biconvex, capsule-shaped, film-coated tablets with
“5/1000” printed
on one side and “4223” printed on the reverse side, in blue ink.

KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 2.5
mg/1000
mg tablets are pale yellow to light yellow, biconvex, capsule-shaped,
film-coated
tablets with “2.5/1000” printed on one side and “4222” printed
on the reverse side, in
blue ink.
THERAPEUTIC INDICATIONS
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to
improve glycemic
control in adults with type 2 diabetes mellitus when treatment with
both saxagliptin and
metformin is appropriate [See Clinical Studies].
IMPORTANT LIMITATIONS OF USE
KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes
mellitus or
diabetic ketoacidosis.
POSOLOGY AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
The dosage of KOMBIGLYZE XR should be individualized on the basis of
the patient’s
current regimen, effectiveness, and tolerability. KOMBIGLYZE XR should
generally be
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61
administered once daily with the evening meal, with gradual dose
titration to reduce the
gastrointestinal side effects associated with metformin. The following
dosage forms are
available:

KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets
5
mg/500 mg

KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets
5 mg/1000 mg

KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets
2.5 mg/1000 mg
The recommended starting dose of KOMBIGLYZE XR in patients who need 5
mg of
saxagliptin and who are not currently treated with metformin is 5 mg
saxagl