Clopidrogrel (Page 6 of 7)

14.2 Recent Myocardial Infarction, Recent Stroke, or Established Peripheral Arterial Disease

CAPRIE
The CAPRIE trial was a 19,185-patient, 304-center, international, randomized, double-blind, parallel-group study comparing clopidogrel (75 mg daily) to aspirin (325 mg daily). The patients randomized had: 1) recent histories of myocardial infarction (within 35 days); 2) recent histories of ischemic stroke (within 6 months) with at least a week of residual neurological signs; or 3) established peripheral arterial disease. Patients received randomized treatment for an average of 1.6 years (maximum of 3 years).
The trial’s primary outcome was the time to first occurrence of new ischemic stroke (fatal or not), new myocardial infarction (fatal or not), or other vascular death. Deaths not easily attributable to nonvascular causes were all classified as vascular.
Table 6: Outcome Events in the CAPRIE Primary Analysis

Patientsclopidogreln=9599aspirinn=9586
Ischemic stroke (fatal or not)438 (4.6%)461 (4.8%)
MI (fatal or not)275 (2.9%)333 (3.5%)
Other vascular death226 (2.4%)226 (2.4%)
Total 939 (9.8%)1020 (10.6%)

As shown in Table 6, clopidogrel was associated with a lower incidence of outcome events, primarily MI. The overall relative risk reduction (9.8% vs. 10.6%) was 8.7%, p=0.045. Similar results were obtained when all-cause mortality and all-cause strokes were counted instead of vascular mortality and ischemic strokes (risk reduction 6.9%). In patients who survived an on-study stroke or myocardial infarction, the incidence of subsequent events was lower in the clopidogrel group.
The curves showing the overall event rate are shown in Figure 8. The event curves separated early and continued to diverge over the 3-year follow-up period.
Figure 8: Fatal or Non-Fatal Vascular Events in the CAPRIE Study

figure8
(click image for full-size original)

The statistical significance favoring clopidogrel over aspirin was marginal (p=0.045). However, because aspirin is itself effective in reducing cardiovascular events in patients with recent myocardial infarction or stroke, the effect of clopidogrel is substantial.The CAPRIE trial included a population that was randomized on the basis of 3 entry criteria. The efficacy of clopidogrel relative to aspirin was heterogeneous across these randomized subgroups (p=0.043). It is not clear whether this difference is real or a chance occurrence. Although the CAPRIE trial was not designed to evaluate the relative benefit of clopidogrel over aspirin in the individual patient subgroups, the benefit appeared to be strongest in patients who were enrolled because of peripheral vascular disease (especially those who also had a history of myocardial infarction) and weaker in stroke patients. In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was not numerically superior to aspirin.

14.3 Lack of Established Benefit of Clopidogrel plus Aspirin in Patients with Multiple Risk Factors or Established Vascular Disease

CHARISMAThe CHARISMA trial was a 15,603 subject, randomized, double-blind, parallel group study comparing clopidogrel (75 mg daily) to placebo for prevention of ischemic events in patients with vascular disease or multiple risk factors for atherosclerosis. All subjects were treated with aspirin 75 to 162 mg daily. The mean duration of treatment was 23 months. The study failed to demonstrate a reduction in the occurrence of the primary endpoint, a composite of CV death, MI, or stroke. A total of 534 (6.9%) patients in the clopidogrel group versus 573 (7.4%) patients in the placebo group experienced a primary outcome event (p=0.22). Bleeding of all severities was more common in the subjects randomized to clopidogrel.

16 HOW SUPPLIED/STORAGE AND HANDLING

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 31722-901-30 Bottles of 30 tablets
NDC 31722-901-90 Bottles of 90 tablets
NDC 31722-901-01 Bottles of 100 tablets
NDC 31722-901-05 Bottles of 500 tablets
NDC 31722-901-10 Bottles of 1000 tablets
Clopidogrel tablets, USP 300 mg are available as pink colored, modified oval shaped, film coated tablets de-bossed on one side with SG and 121 on other side. Tablets are provided as follows:
NDC 31722-902-30 Bottles of 30 tablets
NDC 31722-902-90 Bottles of 90 tablets
NDC 31722-902-01 Bottles of 100 tablets
NDC 31722-902-05 Bottles of 500 tablets
Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

[See Medication Guide]

17.1 Benefits and Risks

• Summarize the effectiveness features and potential side effects of clopidogrel tablets, USP.
• Tell patients to take clopidogrel tablets, USP exactly as prescribed.• Remind patients not to discontinue clopidogrel tablets, USP without first discussing it with the physician who prescribed clopidogrel tablets, USP.

17.2 Bleeding

Inform patients that they:
• will bruise and bleed more easily.
• will take longer than usual to stop bleeding. • should report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine.

17.3 Other Signs and Symptoms Requiring Medical Attention

• Inform patients that TTP is a rare but serious condition that has been reported with clopidogrel tablets, USP and other drugs in this class of drugs. • Instruct patients to get prompt medical attention if they experience any of the following symptoms that cannot otherwise be explained: fever, weakness, extreme skin paleness, purple skin patches, yellowing of the skin or eyes, or neurological changes.

17.4 Invasive Procedures

Instruct patients to:
• inform physicians and dentists that they are taking clopidogrel tablets, USP before any invasive procedure is scheduled.
• tell the doctor performing the invasive procedure to talk to the prescribing health care professional before stopping clopidogrel tablets, USP.

17.5 Concomitant Medications

Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take [see Warnings and Precautions (5)].
Coumadin® is a registered trademark of Bristol-Myers Squibb Pharma Company.
Prilosec® and Nexium® are registered trademark of AstraZeneca.
Jantoven® is a registered trademark of USL Pharma.
Manfactured for :

address1

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
Rev. 04/14

MEDICATION GUIDE

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:
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.
• 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 hance of blood clots forming in your body. While you take clopidogrel tablets, USP:
• 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, 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?
Clopidogrel tablets, USP is a prescription medicine used to treat people who have any of the following:
• chest pain due to heart problems
• poor circulation in their legs (peripheral arterial disease)
• a heart attack
• a stroke
Clopidogrel tablets, USP are used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.
Platelets are blood cells that help your blood clot normally. Clopidogrel tablets, USP helps to prevent platelets from sticking together and forming a clot that can block an artery.
It is not known if clopidogrel tablets, USP are safe and effective in children.
Who should not take clopidogrel tablets, USP?
Do not take clopidogrel tablets, USP if you:
• currently have a condition that causes bleeding, such as a stomach ulcer
• are allergic to clopidogrel or other ingredients in clopidogrel tablets, USP. See the end of this leaflet for a complete list of ingredients in clopidogrel tablets, USP.
What should I tell my doctor before taking clopidogrel tablets, USP?
Before you take clopidogrel tablets, USP, tell your doctor if you:
• have a history of bowel (gastrointestinal) or stomach ulcers
• have a history of bleeding problems
• plan to have surgery or a dental procedure. See “How should I take clopidogrel tablets, USP?”
• are pregnant or plan to become pregnant. It is not known if clopidogrel tablets, USP will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if clopidogrel passes into your breast milk. You and your doctor should decide if you will take clopidogrel tablets, USP or breastfeed. You should not do both without talking to your doctor.
• have had an allergy or reaction to any medicine used to treat your disease.
Tell all of your doctors and your dentist that you are taking clopidogrel tablets, USP. They should talk to the doctor who prescribed clopidogrel tablets, USP for you before you have any surgery or invasive procedure.
Tell your doctor about all the medicines you take , including prescription, non-prescription medicines, vitamins and herbal supplements.
Clopidogrel tablets, USP may affect the way other medicines work, and other medicines may affect how clopidogrel tablets, USP works. See “What is the most important information I should know about clopidogrel tablets, USP?”
Taking clopidogrel tablets, USP with certain other medicines may increase your risk of bleeding.
Especially tell your doctor if you take:
• aspirin, especially if you have had a stroke. Always talk to your doctor about whether you should take aspirin along with clopidogrel tablets, USP to treat your condition.
• Non-steroidal anti-inflammatory drugs (NSAIDs). Ask your doctor or pharmacist for a list of NSAID medicines if you are not sure.
• warfarin (Coumadin®, Jantoven®)
• selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). Ask your doctor or pharmacist for a list of SSRI or SNRI medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I take clopidogrel tablets, USP?
• Take clopidogrel tablets, USP exactly as your doctor tells you.
• Do not change your dose or stop taking clopidogrel tablets, USP without talking to your doctor first. Stopping clopidogrel tablets, USP may increase your risk of heart attack or stroke.
• Take clopidogrel tablets, USP with aspirin as instructed by your doctor.
• You can take clopidogrel tablets, USP with or without food.
• If you miss a dose, take clopidogrel tablets, USP as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses of clopidogrel tablets, USP at the same time unless your doctor tells you to.
• If you take too much clopidogrel tablets, USP, call your doctor or go to the nearest emergency room right away.
• Talk with your doctor about stopping your clopidogrel tablets, USP before you have surgery. Your doctor may tell you to stop taking clopidogrel tablets, USP at least 5 days before you have surgery to avoid excessive bleeding during surgery.
What are the possible side effects of clopidogrel tablets, USP?
Clopidogrel tablets, USP can cause serious side effects including:
• See “What is the most important information I should know about clopidogrel tablets, USP?”
A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with clopidogrel tablets, USP, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels; and can happen anywhere in the body. TTP needs to be treated in a hospital right away, because it may cause death. Get medical help right away if you have any of these symptoms and they can not be explained by another medical condition:
• purplish spots (called purpura) on the skin or in the mouth (mucous membranes) due to bleeding under the skin
• your skin or the whites of your eyes are yellow (jaundice)
• you feel tired or weak
• your skin looks very pale
• fever
• fast heart rate or feeling short of breath
• headache
• speech changes
• confusion
• coma
• stroke
• seizure
• low amount of urine, or urine that is pink or has blood in it
• stomach area (abdominal) pain
• nausea, vomiting, or diarrhea
• vision changes
Tell your doctor if you have any side effect that bothers you or that does not go away. Tell your doctor if you develop an allergic reaction including skin reactions while taking clopidogrel tablets, USP.
These are not all the possible side effects of clopidogrel tablets, USP. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store clopidogrel tablets, USP?
• Store clopidogrel tablets at 59°F to 86°F (15°C to 30°C).
Keep clopidogrel tablets, USP and all medicines out of the reach of children.
General information about clopidogrel tablets, USP
Medicines are sometimes used for purposes other than those listed in a Medication Guide. Do not take clopidogrel tablets, USP for a condition for which it was not prescribed. Do not give clopidogrel tablets, USP to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about clopidogrel tablets, USP. If you would like more information, talk to your doctor. Ask your doctor or pharmacist for information about clopidogrel tablets, USP that was written for healthcare professionals.
For more information, contact ScieGen Pharmaceuticals Inc at 1-855-724-3436.
What are the ingredients in clopidogrel tablets, USP?
Active ingredient: clopidogrel bisulfate, USP
Inactive ingredients:
Tablet: microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil
Film coating: Hypromellose, titanium dioxide, polyethylene glycol and red iron oxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Coumadin® is a registered trademark of Bristol-Myers Squibb Pharma Company.
Prilosec® and Nexium® are registered trademark of AstraZeneca.
Jantoven® is a registered trademark of USL Pharma.
Manfactured for :

address2

Manufactured by:
ScieGen Pharmaceuticals Inc
Hauppauge, NY 11788
USARev: 07/2015

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