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Plavix® (Brand)

PLAVIX (Clopidogrel bisulfate) is proven to help keep platelets from sticking together and forming blood clots. This helps blood flow more easily, helping to reduce the risk of a future heart attack or stroke.

Plavix (Brand) 75mg Pills

Uses

PLAVIX is used to prevent the following:
Heart-related chest pain, heart attack, ischemic stroke (the most common type of stroke), and peripheral artery disease, or P.A.D.-poor circulation in the legs, which may cause pain or heaviness in the legs during exercise, such as walking, that may be relieved by rest-are all serious medical conditions. What do they have in common? One answer lies with sticky platelets and the blood clots they can form in your arteries.
Clot formation is a natural defense mechanism of the body, which works to protect you from excessive bleeding in the case of an injury. When you cut yourself, particles in your blood called platelets stick together to form a clot. Clot formation can also be triggered by the rupture of plaque (a buildup of cholesterol and other materials) inside the walls of arteries. When platelets clump together on or near the plaque, they can form a clot that may limit or completely stop the flow of blood to various parts of the body. If a clot forms in an artery supplying blood to the heart, heart-related chest pain or a heart attack can occur. If a clot forms in an artery leading to the brain, a stroke can occur.

How to take

Acute Coronary Syndrome Remember, your doctor is the single best source of information regarding your health. Please consult your doctor if you have any questions about your health, your medicine, or experience any side effects of PLAVIX.
PLAVIX is generally well tolerated, but it is not for everyone. Your therapy is designed for your individual condition and medical history. Discuss any side effects of PLAVIX you may experience with your doctor. Your doctor will explain if there are any circumstances under which you should discontinue your therapy.
In clinical trials, the most common side effects were severe itching (pruritus), a severe rash characterized by the appearance of purplish spots or patches (purpura), diarrhea, and rash. Less common, but serious, side effects of PLAVIX may occur.

For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), PLAVIX should be initiated with a single 300-mg loading dose and then continued at 75mg once daily. Aspirin (75mg-325mg once daily) should be initiated and continued in combination with PLAVIX. In CURE, most patients with Acute Coronary Syndrome also received heparin acutely.
For patients with ST-segment elevation acute myocardial infarction, the recommended dose of PLAVIX is 75mg once daily, administered in combination with aspirin, with or without thrombolytics. PLAVIX may be initiated with or without a loading dose (300mg was used in CLARITY.
PLAVIX can be administered with or without food.

Side effects

Remember, your doctor is the single best source of information regarding your health. Please consult your doctor if you have any questions about your health, your medicine, or experience any side effects of PLAVIX.
PLAVIX is generally well tolerated, but it is not for everyone. Your therapy is designed for your individual condition and medical history. Discuss any side effects of PLAVIX you may experience with your doctor. Your doctor will explain if there are any circumstances under which you should discontinue your therapy.
In clinical trials, the most common side effects were severe itching (pruritus), a severe rash characterized by the appearance of purplish spots or patches (purpura), diarrhea, and rash. Less common, but serious, side effects of PLAVIX may occur.
If you have a stomach ulcer or other condition that causes bleeding, you should not use PLAVIX. When taking PLAVIX alone or with some other medicines including aspirin, the risk of bleeding may increase so tell your doctor before planning surgery. And, always talk to your doctor before taking aspirin or other medicines with PLAVIX, especially if you've had a stroke. If you develop fever, unexplained weakness or confusion, tell your doctor promptly as these may be signs of a rare but potentially life-threatening condition called TTP, which has been reported rarely, sometimes in less than 2 weeks after starting therapy. Other rare but serious side effects may occur.
Tell your doctor if you have any bleeding or other problems while you are taking PLAVIX.

Precaution

PLAVIX prolongs the bleeding time and therefore should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions (particularly gastrointestinal and intraocular). If a patient is to undergo elective surgery and an antiplatelet effect is not desired, PLAVIX should be discontinued 5days prior to surgery.

Due to the risk of bleeding and undesirable hematological effects, blood cell count determination and/or other appropriate testing should be promptly considered, whenever such suspected clinical symptoms arise during the course of treatment.

In patients with recent TIA or stroke who are at high risk of recurrent ischemic events, the combination of aspirin and PLAVIX has not been shown to be more effective than PLAVIX alone, but the combination has been shown to increase major bleeding.

GI Bleeding: In CAPRIE, PLAVIX was associated with a rate of gastrointestinal bleeding of 2.0%, vs. 2.7% on aspirin. In CURE, the incidence of major gastrointestinal bleeding was 1.3% vs. 0.7% (PLAVIX + aspirin vs. placebo + aspirin, respectively). PLAVIX should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions should be used with caution in patients taking PLAVIX.

Use in Hepatically Impaired Patients: Experience is limited in patients with severe hepatic disease, who may have bleeding diatheses. PLAVIX should be used with caution in this population.

Use in Renally-impaired Patients: Experience is limited in patients with severe renal impairment. PLAVIX should be used with caution in this population.

Drug interactions

Aspirin: Aspirin did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation. Concomitant administration of 500mg of aspirin twice a day for 1day did not significantly increase the prolongation of bleeding time induced by PLAVIX. PLAVIX potentiated the effect of aspirin on collagen-induced platelet aggregation. PLAVIX and aspirin have been administered together for up to one year.

Heparin: In a study in healthy volunteers, PLAVIX did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Co administration of heparin had no effect on inhibition of platelet aggregation induced by PLAVIX.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): In healthy volunteers receiving naproxen, concomitant administration of PLAVIX was associated with increased occult gastrointestinal blood loss. NSAIDs and PLAVIX should be co administered with caution.

Warfarin: Because of the increased risk of bleeding, the concomitant administration of warfarin with PLAVIX should be undertaken with caution.

Other Concomitant Therapy: No clinically significant pharmacodynamic interactions were observed when PLAVIX was co administered with atenolol, nifedipine, or both atenolol and nifedipine. The pharmacodynamic activity of PLAVIX was also not significantly influenced by the co administration of phenobarbital, cimetidine or estrogen.

The pharmacokinetics of digoxin or theophylline was not modified by the co administration of PLAVIX (clopidogrel bisulfate).

At high concentrations invitro, clopidogrel inhibits P450 (2C9). Accordingly, PLAVIX may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, and many non-steroidal anti-inflammatory agents, but there are no data with which to predict the magnitude of these interactions. Caution should be used when any of these drugs is co administered with PLAVIX.

In addition to the above specific interaction studies, patients entered into clinical trials with PLAVIX received a variety of concomitant medications including diuretics, beta-blocking agents, angiotensin converting enzyme inhibitors, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), thrombolytics, heparins (unfractionated and LMWH), GPIIb/IIIa antagonists, antiepileptic agents and hormone replacement therapy without evidence of clinically significant adverse interactions.

There are no data on the concomitant use of oral anticoagulants, non-study oral anti-platelet drugs and chronic NSAIDs with clopidogrel.

Missed dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Storage

Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep away from children and pets.