CLOPIDOGREL- clopidogrel bisulfate tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Golden State Medical Supply, Inc.

INN (nume internaţional):

CLOPIDOGREL BISULFATE

Compoziție:

CLOPIDOGREL 75 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

- 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)] .

Rezumat produs:

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: Bottles of 30 NDC 51407-032-30 Bottles of 90 NDC 51407-032-90 Bottles of 1,000 NDC 51407-032-10 Store at 25°C(77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container [see USP]. Protect from moisture.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Clopidogrel(kloe pid’ oh grel) Tablets, USP
Medication Guide available at
https://www.apotex.com/products/us/mg.asp
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 tablets?
Clopidogrel tablets are a prescrip

Caracteristicilor produsului

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CLOPIDOGREL TABLETS. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE
INFORMATION NEEDED TO
USECLOPIDOGRELTABLETSSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION
FORCLOPIDOGRELTABLETS.
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 are 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 has been shown to reduce the
rate of myocardial infarction (MI)
and stroke. ( 1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets has been shown to
reduce the rate of MI and stroke. ( 1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablets has 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 u