CLOPIDOGREL BISULFATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clopidogrel bisulfate (UNII: 08I79HTP27) (Clopidogrel - UNII:A74586SNO7)

Available from:

Proficient Rx LP

INN (International Name):

Clopidogrel bisulfate

Composition:

Clopidogrel 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

 The optimal duration of clopidogrel therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. Clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2) ]. 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 repr

Product summary:

Clopidogrel tablets, USP 75 mg are available as pink colored, round shaped, biconvex, film coated tablets de-bossed on one side with SG and 124 on other side. Tablets are provided as follows:  NDC 63187-639-30                                                   Bottles of 30 NDC 63187-639-60                                                   Bottles of 60 NDC 63187-639-90                                                   Bottles of 90 Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOPIDOGREL BISULFATE- 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, USP 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, USP?
1. Clopidogrel tablets, USP may not work as well in people who:
1.
have certain genetic factors that affect how the body breaks down
clopidogrel. Your doctor may do
genetic tests to make sure clopidogrel tablets, USP are right for you.
2.
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,USP.
2. Clopidogrel tablets, USP can cause bleeding which can be serious
and can sometimes lead to death.
Clopidogrel is a blood thinner medicine that lowers the chance of
blood clots forming in your body.
While you take clopidogrel tablets, USP:
1.
you may bruise and bleed more easily
2.
you are more likely to have nose bleeds
3.
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:
1.
unexpected bleeding or bleeding that lasts a long time
2.
blood in your urine (pink, red or brown urine)
3.
red or black stools (looks like tar)
4.
bruises that happen without a known cause or get larger
5.
cough up blood or blood clots
6.
vomit blood or your vomit looks like coffee grounds
Do not stop taking clopidogrel tablets, USP without talking to the
doctor who prescribes it for you. People
who stop taking clopidogrel tablets, USP too soon have a higher risk
of having a heart attack or dying. If
you must stop clopidogrel tablets, USP because of bleeding, your risk
of a heart attack may be higher.
What is clopidogrel tablets, USP?
Clopido

Summary of Product characteristics

CLOPIDOGREL BISULFATE- 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, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS,
USP.
CLOPIDOGREL TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
5.
6.
7.
8.
INDICATIONS AND USAGE
CLOPIDOGREL is a P2Y platelet inhibitor indicated for:
•
- For patients with ST-elevation myocardial infarction (STEMI),
CLOPIDOGREL 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. The benefit for patients who
undergo primary PCI is unknown. (1.1)
2.
DOSAGE AND ADMINISTRATION
2.
- UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in
combination with aspirin (75 to 325 mg once daily)
- STEMI: 75 mg once daily, in combination with aspirin (75-325 mg once
daily), with or without a loading dose
2.
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg, 300 mg (3)
CONTRAINDICATIONS
3.
4.
WARNINGS AND PRECAUTIONS
7.
8.
EFFECTIVENESS OF CLOPIDOGREL TABLETS DEPENDS ON ACTIVATION TO AN
ACTIVE METABOLITE BY THE
CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH CLOPIDOGREL TABLETS AT RECOMMENDED
DOSES EXHIBIT HIGHER
CARDIOVASCULAR EVENT RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR
PERCUTANEOUS CORONARY
INTERVENTION (PCI) THAN PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5)
TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN
BE USED AS AN AID IN
DETERMINING THERAPEUTIC STRATEGY. (12.5)
CONSIDER ALTERNATIVE TREATMENT OR TREATMENT STRATEGIES IN PATIENTS
IDENTIFIED AS CYP2C19 POOR
METABOLIZERS. (2.3, 5.1)
12
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS [unstable angina
(UA)/non-ST-elevation myocardial infarction
(NSTEMI)], CLOPIDOGREL has been sho