CLOPIDOGREL WINTHROP PLUS ASPIRIN 75 mg/75 mg clopidogrel (as hydrogen sulfate)/aspirin tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Aspirin,clopidogrel hydrogen sulfate

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Summary of Product characteristics

PRODUCT INFORMATION
Clopidogrel Winthrop Plus Aspirin - Clopidogrel+Aspirin
clopidogrel-winthrop-plus-aspirin-ccdsv16-piv14-14sep17
1
PRODUCT INFORMATION
CLOPIDOGREL WINTHROP PLUS ASPIRIN
® 75MG/75MG &
CLOPIDOGREL WINTHROP PLUS ASPIRIN
®
75MG/100MG
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Clopidogrel Winthrop Plus Aspirin 75mg/75mg containing clopidogrel 75
mg (as
clopidogrel hydrogen sulfate) and aspirin 75 mg
Clopidogrel Winthrop Plus Aspirin 75mg/100mg containing clopidogrel 75
mg (as
clopidogrel hydrogen sulfate) and aspirin 100 mg
CHEMICAL STRUCTURE
CLOPIDOGREL
Clopidogrel hydrogen sulfate has the following chemical structure:
C
O
O
S
N
H
Cl
,H
2
SO
4
CH
3
Molecular Formula: C
16
H
16
ClNO
2
S.H
2
SO
4
Molecular Weight: 419.9
Chemical Name: methyl
(+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c] pyridine-
5(4H)-acetate sulfate (1:1).
CAS number: 120202-66-6 (Clopidogrel hydrogen sulfate), 113 665-84-2
(Clopidogrel
base).
PRODUCT INFORMATION
Clopidogrel Winthrop Plus Aspirin - Clopidogrel+Aspirin
clopidogrel-winthrop-plus-aspirin-ccdsv16-piv14-14sep17
2
ASPIRIN
Aspirin has the following chemical structure:
Molecular Formula: C
9
H
8
O
4
Molecular Weight: 180.2
Chemical Name: 2-acetoxybenzoic acid.
CAS number: 50-78-2
DESCRIPTION
CLOPIDOGREL
Clopidogrel hydrogen sulfate is a white to off-white powder. It is
practically insoluble in
water at neutral pH but freely soluble at pH 1. It is freely soluble
in methanol, sparingly
soluble in methylene chloride and is practically insoluble in ethyl
ether. It has a specific
optical rotation of about + 56°.
ASPIRIN
Aspirin
is
a
white
crystalline
powder
or
colourless
crystals,
odourless
or
almost
odourless, slightly soluble in water, freely soluble in alcohol,
soluble in chloroform and
in ether. It melts at about 135°C.
CLOPIDOGREL WINTHROP PLUS ASPIRIN
Clopidogrel Winthrop Plus Aspirin tablets are film coated and for both
strengths each
tablet contains mannitol, macrogol 6000, microcrystalline cellulose,
hydrogenated castor
oil hyprolose, maize starch, stearic ac