CLOPIDOGREL tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)

Disponível em:

Direct_Rx

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

1.1 Acute Coronary Syndrome (ACS) Clopidogreltablets are indicated to reduce the rate of myocardial infarction and stroke (MI) in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogreltablets should be administered in conjunction with aspirin. Clopidogreltablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke. 4.1 Active Bleeding Clopidogrel tablets are contraindi

Resumo do produto:

Clopidogrel tablets, USP 75 mg are available as pink, round, biconvex, film-coated tablets imprinted with “894” on one side and plain on the other side. Tablets are provided as follows: Bottles of 30’s with Child Resistant Cap…………… Bottles of 90’s with Child Resistant Cap…………… Bottles of 90’s with Non Child Resistant Cap……… Bottles of 500’s with Non Child Resistant Cap……. Bottles of 1000’s with Non Child Resistant Cap…... Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in USP. U.S. Patent No. 6,429,210 and 6,504,030

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
Direct_Rx
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Clopidogrel Tablets, USP
(kloe-PID-oh-grel)
Read this Medication Guide before you start taking clopidogrel tablets
and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about clopidogrel
tablets?
1. Clopidogrel tablets may not work as well in people who:
have certain genetic factors that affect how the body breaks down
clopidogrel. Your doctor may do
genetic tests to make sure clopidogrel tablets are right for you.
take certain medicines, especially omeprazole (Prilosec®*) or
esomeprazole (Nexium®*). Your doctor
may change the medicine you take for stomach acid problems while you
take clopidogrel tablets.
2. Clopidogrel tablets can cause bleeding which can be serious and can
sometimes lead to death.
Clopidogrel tablets are a blood thinner medicine that lowers the
chance of blood clots forming in your
body. While you take clopidogrel tablets:
you may bruise and bleed more easily
you are more likely to have nose bleeds
it will take longer for any bleeding to stop
Call your doctor right away if you have any of these signs or symptoms
of bleeding:
unexpected bleeding or bleeding that lasts a long time
blood in your urine (pink, red or brown urine)
red or black stools (looks like tar)
bruises that happen without a known cause or get larger
cough up blood or blood clots
vomit blood or your vomit looks like coffee grounds
Do not stop taking clopidogrel tablets without talking to the doctor
who prescribes it for you. People who
stop taking clopidogrel tablets too soon have a higher risk of having
a heart attack or dying. If you must
stop clopidogrel tablets because of bleeding, your risk of a heart
attack may be higher.
What are clopidogrel tablets?
Clopidogrel tablets are prescription medicines used to treat people
who have any of the following:
chest pain due to heart prob

Características técnicas

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
DIRECT_RX
----------
CLOPIDOGREL
1.1 Acute Coronary Syndrome (ACS)
Clopidogreltablets are indicated to reduce the rate of myocardial
infarction and stroke (MI) in patients
with non-ST-segment elevation ACS (unstable angina
[UA]/non-ST-elevation myocardial infarction
[NSTEMI]), including patients who are to be managed medically and
those who are to be managed with
coronary revascularization. Clopidogreltablets should be administered
in conjunction with aspirin.
Clopidogreltablets are indicated to reduce the rate of myocardial
infarction and stroke in patients with
acute ST-elevation myocardial infarction (STEMI) who are to be managed
medically. Clopidogrel
tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial
Disease
In patients with established peripheral arterial disease or with a
history of recent myocardial infarction
(MI) or recent stroke clopidogrel tablets are indicated to reduce the
rate of MI and stroke.
2.1 Acute Coronary Syndrome
In patients who need an antiplatelet effect within hours, initiate
clopidogrel tablets with a single 300 mg
oral loading dose and then continue at 75 mg once daily. Initiating
clopidogrel tablets without a loading
dose will delay establishment of an antiplatelet effect by several
days [see Clinical Pharmacology (12.3)
and Clinical Studies (14.1)].
2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial
Disease
75 mg once daily orally without a loading dose [see Clinical
Pharmacology (12.3) and Clinical Studies
(14.2)].
75 mg tablets: Pink, round, biconvex, film-coated tablets imprinted
with “894” on one side and plain on
the other side
4.1 Active Bleeding
Clopidogrel tablets are contraindicated in patients with active
pathological bleeding such as peptic
ulcer or intracranial hemorrhage.
4.2 Hypersensitivity
Clopidogrel tablets are contraindicated in patients with
hypersensitivity (e.g., anaphylaxis) to
clopidogrel or any component of the product [see