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• Plavedamol indications
• Uses of Plavedamol in details
• Plavedamol description
• Plavedamol dosage
• Plavedamol interactions
• Plavedamol side effects
• Plavedamol contraindications

What is Plavedamol?

Plavedamol is used alone or together with aspirin to lessen the chance of a heart attack or stroke. It is given to patients who have already had a heart attack, severe chest pain, or a stroke, or to patients with other circulation problems that could cause a stroke or heart attack.

A heart attack or stroke may occur when a blood vessel is blocked by a blood clot. Plavedamol is a platelet inhibitor. It reduces the chance that a harmful blood clot will form by preventing platelets from clumping together in the blood. Plavedamol may also increase the chance of serious bleeding in some people.

Plavedamol is available only with your doctor's prescription.

Plavedamol indications

Prevention of atherothrombotic events in: Recent MI, Recent Stroke or Established Peripheral Arterial Disease: For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Plavedamol has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.

Acute Coronary Syndrome: For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or coronary artery bypass graft (CABG), Plavedamol has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke or refractory ischemia.

For patients with ST-segment elevation acute MI, Plavedamol has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, reinfarction or stroke.

Atrial Fibrillation: In patients with atrial fibrillation (AF) at increased risk of vascular events who can take vitamin K antagonist (VKA) therapy, VKA has been shown to be associated with a better clinical benefit than acetylsalicylic acid (aspirin) alone or the combination of Plavedamol and aspirin for the reduction of stroke.

In patients with atrial fibrillation who have at least 1 risk factor for vascular events and who cannot take VKA therapy [eg, specific risk of bleeding, physician assessment that patient is unable to comply with international normalized ratio (INR) monitoring or that VKA use is inappropriate], Plavedamol is indicated in combination with aspirin for the prevention of atherothrombotic and thromboembolic events, including stroke. Plavedamol in combination with aspirin has been shown to reduce the rate of the combined endpoint of stroke, myocardial infarction (MI), non-CNS systemic embolism, or vascular death, largely through a reduction in stroke.

How should I use Plavedamol?

Use Plavedamol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Plavedamol by mouth with or without food.
• Take Plavedamol on a regular schedule to get the most benefit from it.
• Do not stop taking Plavedamol without talking to your doctor. This may increase the risk of heart problems.
• If you miss a dose of Plavedamol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Plavedamol.

Uses of Plavedamol in details

Use: Labeled Indications

Acute coronary syndrome:

ST-segment elevation myocardial infarction: To reduce the rate of myocardial infarction (MI) and stroke in conjunction with aspirin in patients with acute ST-elevation MI who are to be managed medically.

Non-ST-segment elevation acute coronary syndromes: To decrease the rate of MI and stroke in conjunction with aspirin in patients with non-ST-segment elevation acute coronary syndromes (unstable angina/non-ST-elevation MI), including patients who are to be managed medically and those who are to be managed with coronary revascularization.

Myocardial infarction, ischemic stroke, or peripheral atherosclerotic disease: To reduce the rate of MI and stroke in patients with a history of recent MI, recent stroke, or established peripheral atherosclerotic disease.

Off Label Uses

Carotid artery atherosclerosis, symptomatic

Based on the American College of Chest Physicians guidelines for antithrombotic therapy in peripheral artery disease, Plavedamol is effective and recommended for patients with symptomatic carotid artery atherosclerosis.

Carotid artery stenting

A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, aspirin in combination with Plavedamol was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

Plavedamol description

Each film-coated tablet contains Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of Plavedamol base 75 mg) or Plavedamol hydrogen sulphate 391.5 mg (molar equivalent of Plavedamol base 300 mg).

Plavedamol also contains the following excipients: Hydrogenated castor oil, hydroxypropyl cellulose, mannitol E421, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredient. The pink film coating contains ferric oxide E172, hypromellose 2910, lactose, titanium dioxide and triacetin. The tablets are polished with carnauba wax.

Plavedamol hydrogen sulfate is methyl(+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). It has an empirical formula of C₁₆H₁₆CINO₂S·H₂SO₄ and a molecular weight of 419.9.

Plavedamol hydrogen sulfate is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.

Plavedamol hydrogen sulfate 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 slightly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°.

Plavedamol dosage

Plavedamol Dosage

Generic name: Plavedamol bisulfate 75mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Acute Coronary Syndrome

Plavedamol can be administered with or without food.

• For patients with non-ST-elevation ACS (UA/NSTEMI), initiate Plavedamol with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75–325 mg once daily) and continue in combination with Plavedamol.
• For patients with STEMI, the recommended dose of Plavedamol is 75 mg once daily orally, administered in combination with aspirin (75–325 mg once daily), with or without thrombolytics. Plavedamol may be initiated with or without a loading dose.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

The recommended daily dose of Plavedamol is 75 mg once daily orally, with or without food.

CYP2C19 Poor Metabolizers

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to Plavedamol. Although a higher dose regimen in poor metabolizers increases antiplatelet response, an appropriate dose regimen for this patient population has not been established.

Use with Proton Pump Inhibitors (PPI)

Avoid using omeprazole or esomeprazole with Plavedamol. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of Plavedamol. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of Plavedamol active metabolite.

More about Plavedamol (Plavedamol)

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Consumer resources

• Plavedamol
• Plavedamol (Advanced Reading)

Professional resources

• Plavedamol (AHFS Monograph)
• Plavedamol (FDA)

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Plavedamol interactions

See also:
What other drugs will affect Plavedamol?

In vitro studies using higher concentrations of Plavedamol showed inhibition of CYP2C9 isoenzyme. Interaction of Plavedamol with drugs eg, tamoxifen, phenytoin, tolbutamide, warfarin, torsemide, fluvastatin and many nonsteroidal anti-inflammatory drugs may be possible. But there are no data to predict the magnitude of these interactions.

The anticoagulant properties of heparin were unaffected by concurrent administration of clinically relevant dosages of Plavedamol.

Concomitant administration of aspirin ≥300 mg/day plus Plavedamol 75 mg/day did not prolong bleeding time to a significantly greater extent than that attributable to Plavedamol alone. The safety of chronic concomitant administration of aspirin and Plavedamol is not established. Plavedamol potentiated the effect of aspirin on collagen-induced platelet aggregation.

Concomitant administration of Plavedamol and naproxen resulted in an increase of occult gastrointestinal blood loss in healthy volunteers.

Co-administration with warfarin has not been studied. Consequently, concomitant administration of these 2 agents should be undertaken with caution.

The steady-state pharmacokinetics profile of digoxin and theophylline was unaffected by co-administration of Plavedamol for 10 days. Similarly, the platelet anti-aggregating properties of Plavedamol were unchanged by co-administration of theophylline in these studies.

There is no evidence of pharmacodynamic interaction between Plavedamol and commonly prescribed cardiovascular medication in patients with symptomatic atherothrombotic disease. Plavedamol retained its full antiplatelet effect, in patients with peripheral arterial obstructive disease taking nifedipine, atenolol or nifedipine and atenolol.

Food: Plavedamol can be taken either before or after food.

Laboratory Tests: None known.

Plavedamol side effects

See also:
What are the possible side effects of Plavedamol?

Adverse effects occurring in at least 2.5% of patients with recent MI, stroke, or established peripheral arterial occlusive disease receiving Plavedamol in the Plavedamol versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) study included chest pain, accidental injury, influenza-like symptoms, pain, fatigue, edema, hypertension, headache, dizziness, abdominal pain, dyspepsia, diarrhea, nausea, hypercholesterolemia, arthralgia, back pain, purpura (bruising), epistaxis, depression, upper respiratory tract infection, dyspnea, rhinitis, bronchitis, coughing, rash, pruritus, and urinary tract infection. Rash and diarrhea were reported more frequently with Plavedamol therapy. Rash classified as severe was more common with Plavedamol therapy.

Adverse effects occurring in at least 2% of patients with unstable angina or non-ST-segment elevation acute coronary syndromes receiving Plavedamol and aspirin in the CURE study included chest pain, headache, dizziness, abdominal pain, dyspepsia or diarrhea. The incidence of major bleeding (principally GI hemorrhage and bleeding at puncture sites), including life-threatening bleeding, was substantially greater in patients receiving Plavedamol and aspirin.

Patients with ST-segment elevation MI, the incidence of major bleeding (intracranial hemorrhage or bleeding associated with a decrease in hemoglobin >5 mg/dL) was similar in patients receiving Plavedamol and aspirin.

The incidence of severe neutropenia (neutrophil count <450/mm³) was similar in patients receiving Plavedamol or aspirin.

Plavedamol contraindications

See also:
What is the most important information I should know about Plavedamol?

Plavedamol should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.

Plavedamol is contraindicated in patients with pheochro-mocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phen-tolamine.

Plavedamol is contraindicated in patients with known sensitivity or intolerance to the drug.

Plavedamol should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

Active ingredient matches for Plavedamol:

Clopidogrel in Egypt.

References

1. PubChem. "clopidogrel". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "clopidogrel". http://www.drugbank.ca/drugs/DB00758 (accessed September 17, 2018).
3. DTP/NCI. "clopidogrel: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology