CLOPIDOGREL- clopidogrel bisulfate tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Proficient Rx LP

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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. Clopidogrel tablets  are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel tablets  are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2)] . Teratogenic Effects Pregnancy Category B     Reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, clopidogrel bisulfate should

Ապրանքի ամփոփագիր:

Clopidogrel Tablets USP, 75 mg are pink colored, round, biconvex, beveled edge, film-coated tablets debossed with ‘E’ on one side and ‘34’ on the other side.          Bottles of 30                                        NDC 71205-073-30          Bottles of 60                                        NDC 71205-073-60          Bottles of 90                                        NDC 71205-073-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.  Preserve in well-closed containers.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

CLOPIDOGREL- clopidogrel bisulfate tablet, film coated
Proficient Rx LP
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Medication Guide
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 tablets. 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 them 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 a prescription

Ապրանքի հատկությունները

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLOPIDOGREL TABLETS.
CLOPIDOGREL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
•
•
•
INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y
platelet inhibitor indicated for:
•
- For patients with non-ST-segment elevation ACS (unstable angina
[UA]/non-ST-elevation myocardial
infarction [NSTEMI]), clopidogrel tablets have been shown to reduce
the rate of myocardial infarction (MI)
and stroke. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets have been shown to
reduce the rate of MI and stroke. (1.1)
•
DOSAGE AND ADMINISTRATION
•
- 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.
•
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
Effectiveness of clopidogrel bisulfate depends on conversion to an
active metabolite by the
cytochrome P450 (CYP) system, principally CYP2C19. (5.1, 12.3)
Tests are available to identify patients who are CYP2C19 poor
metabolizers. (12.5)
Consider use of another platelet P2Y12 inhibitor in patients
identified as CYP2C19 poor
metabolizers. Error! Hyperlink reference not valid.5.1)
12
Acute coronary syndrome
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablets have been
shown to reduce the rate of MI and stroke. (1.2)
Acute coronary syndrome (2.1)
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily orally without a
loading dose (2.2)
Active pathological bleeding, such as peptic ulcer or intracranial
hemorrhage (4.1)
Hypersensitivity to clopidogrel or any compon