Clopidogrel Sandoz

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel;  

Disponible depuis:

Sandoz New Zealand Limited

DCI (Dénomination commune internationale):

Clopidogrel bisulfate 97.875 mg (equivalent to 75 mg clopidogrel)

Dosage:

75 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel   Excipient: Hydrogenated vegetable oil Hyprolose Mannitol Microcrystalline cellulose Opacode black S-1-17823 Opadry Pink Purified water

Unités en paquet:

Blister pack, Al/Al, 28 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Dr Reddy's Laboratories Limited

indications thérapeutiques:

Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, Al/Al - 28 tablets - 2 years from date of manufacture stored at or below 25°C

Date de l'autorisation:

2010-05-07

Résumé des caractéristiques du produit

NEW ZEALAND DATASHEET
CLOPIDOGREL SANDOZ
_®_
_CLOPIDOGREL FILM-COATED TABLETS 75MG _
NAME OF THE MEDICINE
Generic name: Clopidogrel hydrogen sulfate
Chemical name:
Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]
pyridine-5(4H)-acetate
sulfate (1:1)
CAS:
120202-66-6 (Clopidogrel hydrogen sulfate)
113 665-84-2 (Clopidogrel base)
Empirical formula:
C
16
H
16
ClNO
2
S.H
2
SO
4
MW:
419.9
DESCRIPTION
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°.
Each tablet contains mannitol, microcrystalline cellulose,
hydroxypropylcellulose, hydrogenated
vegetable oil, Opadry Pink 03B54942 and Opacode S-1-17823 Black.
PHARMACOLOGY
_PHARMACODYNAMICS _
Clopidogrel is a specific and potent inhibitor of platelet
aggregation. Platelets have an established role
in the pathophysiology of atherosclerotic disease and thrombotic
events. Long term use of anti-platelet
drugs has shown consistent benefit in the prevention of ischaemic
stroke, myocardial infarction and
vascular death in patients at increased risk of such outcomes,
including those with established
atherosclerosis or a history of atherothrombosis.
Clopidogrel selectively inhibits the binding of adenosine diphosphate
(ADP) to its platelet receptor, and
the subsequent ADP-mediated activation of the GPIIb/IIIa complex,
thereby inhibiting platelet
aggregation. Biotransformation of clopidogrel is necessary to produce
inhibition of platelet
aggregation. The active metabolite, a thiol derivative, is formed by
oxidation of clopidogrel to 2-
oxoclopidogrel and subsequent hydrolysis. The active thiol metabolite,
which has been isolated _in _
_vitro_, binds rapidly and irreversibly to platelet ADP receptors,
P2Y12, thus inhibiting platelet
aggregation. Clopidogrel also inhibits platelet aggregation induced by
other agoni