Plavix

DRUG DESCRIPTION

Plavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-?-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9.

The structural formula is as follows:

PLAVIX (clopidogrel bisulfate) Structural Formula Illustration

Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56.

Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base.

Each tablet contains hydrogenated castor oil, hydroxypropylcellulose, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin. The tablets are polished with Carnauba wax.

What are the possible side effects of clopidogrel (Plavix)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using clopidogrel and call your doctor at once if you have any of these serious side effects:

  • nosebleed or other bleeding that will not stop;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...

Read All Potential Side Effects and See Pictures of Plavix


Plavix Patient Information Including Side Effects

Brand Names: Plavix

Generic Name: clopidogrel (Pronunciation: kloe PID oh grel)

  • What is clopidogrel (Plavix)?
  • What are the possible side effects of clopidogrel (Plavix)?
  • What is the most important information I should know about clopidogrel (Plavix)?
  • What should I discuss with my healthcare provider before taking clopidogrel (Plavix)?
  • How should I take clopidogrel (Plavix)?
  • What happens if I miss a dose (Plavix)?
  • What happens if I overdose (Plavix)?
  • What should I avoid while taking clopidogrel (Plavix)?
  • What other drugs will affect clopidogrel (Plavix)?
  • Where can I get more information?

What is clopidogrel (Plavix)?

Clopidogrel keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Clopidogrel is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.

Clopidogrel may also be used for other purposes not listed in this medication guide.

What are the possible side effects of clopidogrel (Plavix)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using clopidogrel and call your doctor at once if you have any of these serious side effects:

  • nosebleed or other bleeding that will not stop;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual.

Less serious side effects may include:

  • stomach pain;
  • runny or stuffy nose, cough, sore throat; or
  • mild headache or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clopidogrel (Plavix)?

Clopidogrel keeps your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. Because of this drug action, clopidogrel can make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of bleeding in your digestive tract.

Avoid drinking alcohol while taking clopidogrel. Alcohol may increase your risk of bleeding in your stomach or intestines.

If you need to have any type of surgery or dental work, tell the surgeon or dentist ahead of time that you are using clopidogrel. You may need to stop using the medicine for at least 5 days before having surgery, to prevent excessive bleeding.

While you are taking clopidogrel, do not take aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

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