Prescription Drug Information: Clopidogrel (Page 5 of 6)

14.3 No Demonstrated Benefit of Clopidogrel plus Aspirin in Patients with Multiple Risk Factors or Established Vascular Disease

CHARISMA
The 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 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 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.

17 PATIENT COUNSELING INFORMATION

Advise patients to read FDA approved patient labeling ( Medication Guide).

Discontinuation
Advise patients not to discontinue clopidogrel without first discussing it with the healthcare provider who prescribed it [see Warnings and Precautions (5.3)].

Bleeding
Advise patients that they:

  • will bruise and bleed more easily
  • will take longer than usual to stop bleeding
  • must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions (5.2)].

Thrombotic Thrombocytopenic Purpura
Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [see Warnings and Precautions (5.4)].

Invasive Procedures
Advise patients to inform physicians and dentists that they are taking clopidogrel before any surgery or dental procedure [see Warnings and Precautions (5.2, 5.3)].

Proton Pump Inhibitors
Advise patients not to take omeprazole or esomeprazole while taking clopidogrel. Dexlansoprazole, lansoprazole and pantoprazole had less pronounced effects on the antiplatelet activity of clopidogrel than did omeprazole or esomeprazole [see Drug Interactions (7.1)].

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Apotex Corp. as follows:
(75 mg / 100 UD) NDC 68084-536-01 packaged from NDC 60505-0253
(300 mg / 30 UD) NDC 68084-752-25 packaged from NDC 60505-3532

Distributed by:
American Health Packaging
Columbus, OH 43217

8275225/0222

Medication Guide

8275225/0222

Clopidogrel Bisulfate Tablets, USP 75 mg and 300 mg
(kloe pid’ oh grel bye sul’ fate)

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 bisulfate tablets are 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 is 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 helps to prevent platelets from sticking together and forming a clot that can block an artery.

It is not known if clopidogrel tablets are safe and effective in children.

Who should not take clopidogrel tablets?
Do not take clopidogrel tablets if you:

  • currently have a condition that causes bleeding, such as a stomach ulcer
  • are allergic to clopidogrel or other ingredients in clopidogrel tablets. See the end of this leaflet for a complete list of ingredients in clopidogrel tablets.

What should I tell my doctor before taking clopidogrel tablets?
Before you take clopidogrel tablets, 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?”
  • are pregnant or plan to become pregnant. It is not known if clopidogrel will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if clopidogrel passes into your breast milk. A decision should be made with your healthcare provider to avoid or discontinue breastfeeding when continuing clopidogrel is needed.
  • 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. They should talk to the doctor who prescribed clopidogrel tablets 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 may affect the way other medicines work, and other medicines may affect how clopidogrel tablets work. See “What is the most important information I should know about clopidogrel tablets?”

Clopidogrel may increase blood levels of other medicines such as repaglinide (Prandin ®).

Taking clopidogrel tablets 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 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?

  • Take clopidogrel tablets exactly as your doctor tells you.
  • Do not change your dose or stop taking clopidogrel tablets without talking to your doctor first. Stopping clopidogrel tablets may increase your risk of heart attack or stroke.
  • Take clopidogrel tablets with aspirin as instructed by your doctor.
  • If you miss a dose, take clopidogrel tablets 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 at the same time unless your doctor tells you to.
  • If you take too much clopidogrel, call your doctor or go to the nearest emergency room right away.
  • Talk with your doctor about stopping your clopidogrel tablets before you have surgery. Your doctor may tell you to stop taking clopidogrel tablets at least 5 days before you have surgery to avoid excessive bleeding during surgery.

What are the possible side effects of clopidogrel tablets?
Clopidogrel tablets can cause serious side effects including:

  • See “What is the most important information I should know about clopidogrel tablets?”
  • A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with clopidogrel, 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
  • Persistent low blood sugar symptoms

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.

These are not all the possible side effects of clopidogrel tablets. 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?

  • Store clopidogrel tablets at 59°F to 86°F (15°C to 30°C). Protect from moisture.

Keep clopidogrel and all medicines out of the reach of children.

General information about clopidogrel tablets
Medicines are sometimes used for purposes other than those listed in a Medication Guide. Do not take clopidogrel tablets for a condition for which it was not prescribed. Do not give clopidogrel tablets 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. If you would like more information, talk to your doctor. Ask your doctor or pharmacist for information about clopidogrel that was written for healthcare professionals.

For more information, go to www.apotex.com or call 1-800-706-5575.

What are the ingredients in clopidogrel tablets?
Active ingredient: clopidogrel bisulfate
Inactive ingredients:
Tablet: anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate
Film coating: red ferric oxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide.

All registered trademarks in this document are the property of their respective owners.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
American Health Packaging Columbus, OH 43217

8275225/0222

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