APO-CLOPIDOGREL/ASPIRIN 75/75 clopidogrel (as hydrogen sulfate)/aspirin 75 mg/75 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel hydrogen sulfate, Quantity: 97.88 mg; aspirin, Quantity: 75 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; titanium dioxide; iron oxide yellow; zinc stearate; maize starch; microcrystalline cellulose; crospovidone; methylcellulose; hypromellose; lactose; colloidal anhydrous silica; macrogol 8000

Administration route:

Oral

Units in package:

280

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Clopidogrel/aspirin is a fixed dose combination product. Clopidogrel/aspirin is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products:,? Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel/aspirin is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent).,? ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, clopidogrel/aspirin has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

Product summary:

Visual Identification: Yellow, oval, biconvex, coated tablet. Engraved "75-75" on one side, "APO" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-08-07

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- CLOPIDOGREL/ASPIRIN (CLOPIDOGREL
HYDROGEN SULFATE/ASPIRIN) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Clopidogrel (as clopidogrel hydrogen sulfate) and Aspirin
(acetylsalicylic acid).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of APO-Clopidogrel/Aspirin 75/75 contains 75 mg
clopidogrel (as clopidogrel
hydrogen sulfate) and 75 mg aspirin.
Each tablet of APO- Clopidogrel/Aspirin 75/100 contains 75 mg
clopidogrel (as clopidogrel
hydrogen sulfate) and 100 mg aspirin.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-Clopidogrel/Aspirin 75/75 tablets:
Yellow, oval, biconvex coated tablet. Engraved “75-75” on one
side, “APO” on the other side.
APO- Clopidogrel/Aspirin 75/100 Tablets:
Light pink, oval biconvex coated tablets, engraved “APO” on one
side, “75-100” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel/Aspirin is a fixed-dose combination product.
Clopidogrel/Aspirin is intended as continuation of therapy in patients
with acute coronary
syndrome already initiated with separate clopidogrel and aspirin
products:
•
Unstable angina or non-ST-elevation myocardial infarction in order to
prevent early and
long-term atherothrombotic events (myocardial infarction, stroke,
vascular death or
refractory ischaemia). Clopidogrel/Aspirin is indicated for the
treatment of acute
coronary syndrome whether or not patients undergo cardiac
revascularisation (surgical
or PCI, with or without stent).
•
ST-segment elevation acute myocardial infarction in order to prevent
atherothrombotic
events. In this population, Clopidogrel/Aspirin has been shown to
reduce the rate of
death from any cause and the rate of a combined endpoint of death,
re-infarction or
stroke in medically treated patients eligible for thrombolytic
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Clopidogrel/Aspirin tablets are intended for oral administration.
2
DOSAGE
ADULTS
Clopidogre