Brand Name

Plavix

Generic Name
Clopidogrel
View Brand Information
FDA approval date: November 17, 1997
Classification: P2Y12 Platelet Inhibitor
Form: Tablet

What is Plavix (Clopidogrel)?

Plavix (clopidogrel) is a potent antiplatelet medication that belongs to a class of drugs known as P2Y12 inhibitors. It works by preventing blood platelets from sticking together and forming dangerous clots in the blood vessels. The FDA has approved Plavix for several critical cardiovascular conditions where preventing blood clots is essential for patient safety. 

Primary FDA-approved uses include:  

  • Prevention of heart attack and stroke in patients with atherosclerosis  
  • Treatment following acute coronary syndrome (ACS)  
  • Prevention of blood clots after stent placement  
  • Peripheral arterial disease (PAD) 

The medication is particularly important for patients who have:  

  • Had a recent heart attack  
  • Experienced a recent stroke  
  • Undergone coronary stent placement  
  • Been diagnosed with peripheral artery disease  
  • Acute coronary syndrome with or without ST-elevation 

Plavix is often prescribed in combination with aspirin, a therapy known as dual antiplatelet therapy (DAPT), which is particularly important for patients who have received coronary stents or experienced acute coronary syndromes. This combination therapy provides enhanced protection against blood clots while balancing the risk of bleeding complications. 

What are the side effects of Plavix? 

As an antiplatelet medication, Plavix’s primary side effects are related to its blood-thinning properties. While the medication is generally well-tolerated, patients need to be aware of potential side effects, particularly those related to bleeding risks. 

Common side effects include:  

  • Easy bruising  
  • Minor bleeding  
  • Nosebleeds  
  • Longer bleeding time from cuts  
  • Headache  
  • Back pain  
  • Dizziness  
  • Nausea 

More serious side effects requiring immediate medical attention:  

  • Severe or unusual bleeding  
  • Blood in urine or stools  
  • Coughing up blood  
  • Bleeding that won’t stop  
  • Unexplained bruising  
  • Signs of blood disorders (fever, weakness, pale skin)  
  • Signs of Thrombotic Thrombocytopenic Purpura (TTP)  
  • Allergic reactions 

Plavix carries a black box warning (the FDA’s strongest warning) regarding:  

  • The reduced effectiveness in poor metabolizers  
  • The importance of genetic testing in some cases  
  • The risk of diminished effectiveness when taken with certain medications, particularly proton pump inhibitors like omeprazole 

Special considerations for patients taking Plavix include:  

  • Increased bleeding risk during surgical procedures  
  • Need to inform all healthcare providers about Plavix use  
  • Importance of carrying medical identification  
  • Need for regular monitoring by healthcare providers 

Is there a generic drug version of Plavix? 

Yes, generic versions of Plavix (clopidogrel) have been available since 2012 when the patent protection expired. The generic version is FDA-approved and considered therapeutically equivalent to brand-name Plavix. The availability of generic clopidogrel has significantly reduced treatment costs, making this important medication more accessible to patients. 

Generic clopidogrel is available in the same strengths as brand-name Plavix and is manufactured by multiple pharmaceutical companies. While the active ingredient remains identical, generic versions may contain different inactive ingredients. However, the FDA requires generic manufacturers to demonstrate that their products are as safe and effective as the brand-name medication. 

Most insurance companies prefer the generic version due to its lower cost, and studies have shown that generic clopidogrel is equally effective in preventing cardiovascular events. Patients should discuss with their healthcare provider if they have any concerns about switching between brand-name and generic versions. 

Plavix Dosage Information 

The dosing of Plavix varies depending on the condition being treated and individual patient factors. The medication is available in 75 mg and 300 mg tablets, with specific dosing regimens based on the clinical situation. 

Standard Dosing Protocols: 

For Acute Coronary Syndrome:  

  • Loading dose: 300-600 mg once  
  • Maintenance dose: 75 mg once daily  
  • Duration: As prescribed by healthcare provider (often 6-12 months minimum) 

For Recent Heart Attack or Stroke:  

  • No loading dose typically required  
  • Maintenance dose: 75 mg once daily  
  • Duration: As determined by healthcare provider 

For Peripheral Arterial Disease:  

  • No loading dose typically required  
  • Maintenance dose: 75 mg once daily  
  • Duration: Long-term therapy as directed 

Important dosing considerations include: 

Administration Guidelines:  

  • Take at the same time each day  
  • Can be taken with or without food  
  • Do not stop taking without consulting healthcare provider  
  • If a dose is missed, take as soon as remembered unless near next scheduled dose 

Special Populations:  

  • No dose adjustment needed for elderly patients  
  • No dose adjustment needed for kidney disease  
  • Genetic testing may be required for some patients  
  • Dose adjustments may be needed based on drug interactions 

Healthcare providers will determine the most appropriate dosing schedule based on individual factors, including:  

  • The specific condition being treated  
  • Other medications being taken  
  • Genetic factors affecting metabolism  
  • Bleeding risk factors  
  • Overall cardiovascular risk 

Regular monitoring is essential while taking Plavix, and patients should:  

  • Keep all scheduled follow-up appointments  
  • Report any unusual bleeding or bruising  
  • Inform all healthcare providers about Plavix use  
  • Carry medical identification indicating Plavix use  
  • Avoid activities with high risk of injury  
  • Monitor for signs of bleeding 

The medication should be stored at room temperature, away from moisture and heat. Patients should never stop taking Plavix without consulting their healthcare provider, as sudden discontinuation can increase the risk of blood clots, particularly in patients with coronary stents. 

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Brand Information

Plavix (clopidogrel)
1DOSAGE FORMS AND STRENGTHS
  • 75 mg tablets: Pink, round, biconvex, film-coated tablets debossed with "75" on one side and "1171" on the other
  • 300 mg tablets: Pink, oblong, film-coated tablets debossed with "300" on one side and "1332" on the other
2ADVERSE REACTIONS
The following serious adverse reactions are discussed below and elsewhere in the labeling:
  • Bleeding
  • Thrombotic thrombocytopenic purpura
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions and durations of follow-up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. The clinically important adverse reactions observed in trials comparing Plavix plus aspirin to placebo plus aspirin and trials comparing Plavix alone to aspirin alone are discussed below.
2.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Plavix. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hemorrhages, including those with fatal outcome, have been reported in patients treated with Plavix.
  • Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A
  • Gastrointestinal disorders: Colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea
  • General disorders and administration site condition: Fever
  • Hepatobiliary disorders: Acute liver failure, hepatitis (noninfectious), abnormal liver function test
  • Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness, insulin autoimmune syndrome, which can lead to severe hypoglycemia
  • Musculoskeletal, connective tissue and bone disorders: Myalgia, arthralgia, arthritis
  • Nervous system disorders: Taste disorders, headache, ageusia
  • Psychiatric disorders: Confusion, hallucinations
  • Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
  • Renal and urinary disorders: Increased creatinine levels
  • Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis (AGEP), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, lichen planus, generalized pruritus
  • Vascular disorders: Vasculitis, hypotension
3OVERDOSAGE
Platelet inhibition by Plavix is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals.
Based on biological plausibility, platelet transfusion may restore clotting ability.
4DESCRIPTION
Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y
The structural formula is as follows:
Chemical Structure
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, hydroxypropyl cellulose, 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.
5HOW SUPPLIED/STORAGE AND HANDLING
Plavix (clopidogrel tablets) 75 mg are available as pink, round, biconvex, film-coated tablets debossed with "75" on one side and "1171" on the other. Tablets are provided as follows:
Plavix (clopidogrel tablets) 300 mg are available as pink, oblong, film-coated tablets debossed with "300" on one side and "1332" on the other. Tablets are provided as follows:
6PATIENT COUNSELING INFORMATION
Advise patients to read FDA approved patient labeling (Medication Guide).
7PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label
NDC 0024-1171-90
Plavix
75 mg
Dispense with
90 Tablets
PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label
8PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Carton
NDC 0024-1332-30
Plavix
30 film-coated tablets
PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Carton