CLOPIDOGREL- clopidogrel bisulfate tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

American Health Packaging

INN (International namn):

CLOPIDOGREL BISULFATE

Sammansättning:

CLOPIDOGREL 75 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

- Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke 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. Clopidogrel should be administered in conjunction with aspirin. - Clopidogrel tablets 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. 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)]. Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data]. There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see Clinical Considerations]. No evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Myocardial infarction and stroke are medical emergencies. Therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus. Labor or delivery Clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. When possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade. Data Human data The available data from published case reports over two decades of postmarketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes. Animal data Embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis. These doses, corresponding to 65 and 78 times the recommended daily human dose, respectively, on a mg/m 2 basis, revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. Risk Summary There are no data on the presence of clopidogrel in human milk or the effects on milk production. No adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases. Studies in rats have shown that clopidogrel and/or its metabolites are present in the milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for clopidogrel and any potential adverse effects on the breastfed infant from clopidogrel or from underlying maternal condition. Safety and effectiveness in pediatric populations have not been established. A randomized, placebo-controlled trial (CLARINET) did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. Possible factors contributing to this outcome were the dose of clopidogrel, the concomitant administration of aspirin, and the late initiation of therapy following shunt palliation. It cannot be ruled out that a trial with a different design would demonstrate a clinical benefit in this patient population. Of the total number of subjects in the CAPRIE and CURE controlled clinical studies, approximately 50% of patients treated with clopidogrel were 65 years of age and older, and 15% were 75 years and older. In COMMIT, approximately 58% of the patients treated with clopidogrel were 60 years and older, 26% of whom were 70 years and older. The observed risk of bleeding events with clopidogrel plus aspirin versus placebo plus aspirin by age category is provided in Table 1 and Table 2 for the CURE and COMMIT trials, respectively [see Adverse Reactions (6.1)]. No dosage adjustment is necessary in elderly patients. Experience is limited in patients with severe and moderate renal impairment [see Clinical Pharmacology (12.2)]. No dosage adjustment is necessary in patients with hepatic impairment [see Clinical Pharmacology (12.2)].

Produktsammanfattning:

Clopidogrel tablets, USP 75 mg are pink, round, biconvex, film coated tablets, engraved "APO" on one side and "CL" over "75" on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-536-01 Clopidogrel tablets, USP 300 mg are pink, oblong, biconvex, film-coated tablets, engraved "APO" on one side and "CL 300" on the other side. They are supplied as follows: Unit dose packages of 20 (4 x 5) NDC 68084-752-19 Unit dose packages of 30 (5 x 6) NDC 68084-752-25 Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

American Health Packaging
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MEDICATION GUIDE
8275225/0423
Clopidogrel Tablets, USP 75 mg and 300 mg
(kloe pid’ oh grel)
To order more Medication Guides call American Health Packaging at
1‐800‐707‐4621.
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 is 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
is 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 t

Produktens egenskaper

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
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
WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-
FUNCTION ALLELES OF THE CYP2C19 GENE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF CLOPIDOGREL TABLETS 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 P2Y INHIBITOR IN PATIENTS IDENTIFIED AS CYP2C19
POOR METABOLIZERS. (5.1)
INDICATIONS AND USAGE
Clopidogrel tablets is a P2Y
platelet inhibitor indicated for:
Acute coronary syndrome
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)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablets have been
shown to reduce the rate of MI and stroke. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
Initiate clopidogrel with a single 300-mg oral loading dose and then
continue at 75 mg once daily.
Initiating clopidogrel without a loading dose will delay establishment
of an antiplatelet effect by several
days.
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily orally without a
loading dose (2.2)
DOSAGE FORMS AND STRENGTHS
Film-coated tablets: 75 mg, 300 mg (3)
CONTRAINDICATIONS
Active pathological bleeding, such as peptic ulcer or intracranial
hemorrhage (