AVANDARYL TABLET 4mg/1mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Glimepiride

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

A10BD04

Dosage:

1mg

Pharmaceutical form:

TABLET, FILM COATED

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SmithKline Beecham Corporation d/b/a GlaxoSmithKine

Authorization date:

2008-06-12

Patient Information leaflet

 
1 
AVANDARYL™ 
ROSIGLITAZONE MALEATE-GLIMEPIRIDE 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
_AVANDARYL_™ tablets contain two oral antidiabetic drugs used in
the management of 
Type 2 diabetes: rosiglitazone (as maleate) and glimepiride. 
  ROSIGLITAZONE 
Rosiglitazone is an oral antidiabetic agent which
acts primarily by increasing insulin 
sensitivity. Rosiglitazone is used in the management of type 2
diabetes mellitus (also 
known
as non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes). 
Rosiglitazone improves glycaemic control while reducing circulating insulin
levels. 
Pharmacological studies in animal models indicate that
rosiglitazone improves sensitivity 
to insulin in muscle and adipose tissue and
inhibits hepatic gluconeogenesis. 
Rosiglitazone is not chemically or functionally related to
the sulphonylureas, the 
biguanides, or the alpha-glucosidase inhibitors. Chemically,
rosiglitazone is (
±)-5-[[4-[2-
(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione,
(_Z_)-2-
butenedioate (1:1), with a molecular weight of 473.52 (357.44
free base). The molecule 
has a single chiral centre and is present as a racemate. Due to
rapid interconversion, the 
enantiomers are functionally indistinguishable. 
The structural formula is: 

The molecular formula is C
18
H
19
N
3
O
3
S
•C
4
H
4
O
4
. Rosiglitazone is a white to off-white 
solid with a melting point range from 122
o
 to 123
o
C. The pK
a
 values of rosiglitazone are 
6.8 and 6.1. It is readily soluble in ethanol and a buffered
aqueous solution with pH of 
2.3; solubility decreases with increasing pH in
the physiological range. 
 GLIMEPIRIDE 
Glimepiride is an oral
antidiabetic drug of the sulphonylurea class.
Glimepiride is a white 
to yellowish-white, crystalline, odourless to
practically odourless powder. Chemically, 
glimepiride is 1-[[p-[2-(3-ethyl