FORXIGA TABLET 10mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Dapagliflozin propanediol 12.30mg eqv dapagliflozin

Tilgængelig fra:

ASTRAZENECA SINGAPORE PTE LTD

ATC-kode:

A10BK01

Dosering:

10mg

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

Dapagliflozin propanediol 12.30mg eqv dapagliflozin 10mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

AstraZeneca Pharmaceuticals LP

Autorisation status:

ACTIVE

Autorisation dato:

2014-04-28

Indlægsseddel

FORXIGA TABLET 

1 
DESCRIPTION  
FORXIGA (dapagliflozin propanediol) is a
potent, highly selective and orally active inhibitor of 
the human renal sodium-glucose
cotransporter 2 (SGLT2), the major transporter responsible for 
renal glucose reabsorption.  
Dapagliflozin propanediol is described chemically as D-glucitol, 1,5-anhydro-1-_C_-[4-chloro-3-
[(4-ethoxyphenyl)methyl]phenyl]-, (1_S_)-, compounded
with (2_S_)-1,2-propanediol, hydrate 
(1:1:1).  The empirical formula is C
21
H
25
ClO
6
•
C
3
H
8
O
2
•
H
2
O  and the molecular weight is 
502.98. The structural formula is: 

FORXIGA  is available as a film-coated tablet for oral administration containing the equivalent 
of 5 mg dapagliflozin as dapagliflozin
propanediol, or the equivalent of 10 mg dapagliflozin as 
dapagliflozin propanediol. 
2 
THERAPEUTIC INDICATIONS  
MONOTHERAPY:  FORXIGA  is indicated as an adjunct to diet and exercise
to improve glycemic 
control in patients with type 2 diabetes mellitus. 
ADD-ON COMBINATION: FORXIGA  is indicated in
patients with type 2 diabetes mellitus to 
improve glycemic control in combination with metformin,

a sulfonylurea, a DPP4 inhibitor (with 
or without metformin), or insulin (alone or with up to two oral antidiabetic
medications) when 
the
existing therapy, along with diet and exercise, does not provide
adequate glycemic control.  
INITIAL COMBINATION:  FORXIGA  is indicated for use
as initial combination therapy with 
metformin, as an adjunct to diet and exercise, to improve
glycemic control in patients with type 2 
diabetes mellitus when dual dapagliflozin and metformin therapy is appropriate. 
FORXIGA is not indicated for use in patients with type
1 diabetes.  
FORXIGA should not be used for the treatment of diabetic
ketoacidosis. 

FORXIGA  has not been studied in�

Produktets egenskaber

1
FORXIGA
®
(DAPAGLIFLOZIN)
1.
NAME OF THE MEDICINAL PRODUCT
FORXIGA tablets, 5 mg and 10 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FORXIGA
5 mg:
Each
film-coated
tablet
contains
5
mg
dapagliflozin
as
dapagliflozin
propanediol.
FORXIGA
10 mg:
Each
film-coated
tablet
contains
10
mg
dapagliflozin
as
dapagliflozin
propanediol.
3.
PHARMACEUTICAL FORM
FORXIGA 5 mg tablets are yellow, biconvex, round, film-coated tablets
with “5” debossed on one
side and “1427” debossed on the other side.
FORXIGA 10 mg tablets are yellow, biconvex, diamond-shaped,
film-coated tablets with “10”
debossed on one side and “1428” debossed on the other side.
For excipients, see section 6.1.
Dapagliflozin propanediol is described chemically as D-glucitol,
1,5-anhydro-1-
_C_
-[4-chloro-3-
[(4-ethoxyphenyl)methyl]phenyl]-, (1
_S_
)-, compounded with (2
_S_
)-1,2-propanediol, hydrate (1:1:1).
The empirical formula is C
21
H
25
ClO
6
•
C
3
H
8
O
2
•
H
2
O and the molecular weight is 502.98. The
structural formula is:
4.
PHARMACEUTICAL FORM
4.1
THERAPEUTIC INDICATIONS
TYPE 2 DIABETES MELLITUS
FORXIGA is indicated in adults with type 2 diabetes mellitus to
improve glycemic control as an
adjunct to diet and exercise. FORXIGA can be given as monotherapy or
in combination with other
medicinal products indicated for the treatment of type 2 diabetes
mellitus.
2
For study results with respect to combination of therapies, effects on
glycemic control and
cardiovascular events, and the populations studied, see sections 4.4,
4.5 and 5.1.
HEART FAILURE
FORXIGA is indicated in adults with heart failure (NYHA class II-IV)
to reduce the risk of
cardiovascular death and hospitalization for heart failure (see
section 5.1).
CHRONIC KIDNEY DISEASE
FORXIGA is indicated as an adjunct to standard therapy to reduce the
risk of sustained eGFR
decline, end-stage kidney disease, and cardiovascular (CV) death in
adults with chronic kidney
disease at risk of progression.
FORXIGA is not indicated for use in patients with type 1 diabetes.
FORXIGA sho