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Vexidogrel 75 mg - 30 F.C. Tablet
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This page may not cover all the information mentioned in the attached pamphlet of the manufacturing company
Medical Description
Antiplatelet agent that belongs to the Thienopyridine group used in the treatment of acute coronary syndrome, Ischemic stroke, ischemic heart disease, percutaneous coronary intervention and coronary artery bypass graft surgery.
Indication & Usage
-Acute coronary syndrome:
A-ST-segment elevation myocardial infarction:
1-If using fibrinolytic therapy for reperfusion: Age ≤75 years: Oral: Initial loading dose: 300 mg once at the time of diagnosis; followed by 75 mg once daily. While if the age is>75 years: Oral: 75 mg once daily.
2-Patient requires percutaneous coronary intervention following fibrinolytic therapy: If the fibrinolytic was administered with a clopidogrel 300 mg loading dose: Oral: Continue 75 mg once daily (do not administer an additional loading dose). While if the fibrinolytic was administered ≤24 hours ago without a loading dose of clopidogrel: Oral: Initial: 300 mg once prior to percutaneous coronary intervention (PCI); followed by 75 mg once daily after PCI. While if the fibrinolytic was administered >24 hours ago without a loading dose of clopidogrel: Oral: Initial: 600 mg once prior to PCI; followed by 75 mg once daily after PCI.
3-If using percutaneous coronary intervention for reperfusion: Oral: Initial: 600 mg once as early as possible before PCI; followed by 75 mg once daily after PCI.
4-Duration of therapy: Preferred approach: Clopidogrel plus aspirin (dual antiplatelet therapy [DAPT]) should be continued for ≥12 months unless major bleeding is a concern. For patients at high risk of bleeding or who experience overt bleeding, DAPT for 6 months may be reasonable, when DAPT is complete, discontinue clopidogrel and continue aspirin indefinitely for secondary prevention. Or the alternative approach in select patients to minimize bleeding events: Clopidogrel in combination with aspirin (DAPT) should be continued for 1 to 3 months after PCI, then discontinue aspirin and continue clopidogrel monotherapy. When clopidogrel is discontinued, restart aspirin for secondary prevention.
-For the rest of indications and usage: refer to Dosage and administration, side effects, storage and pregnancy and laction sections.
Active Ingredients
Clopidogrel
Recommended Doctors
Dosage & Administration
-Administer without regard to meals.
-Indications and usage(continue):
B-Non-ST-segment elevation acute coronary syndromes:
1-If using an ischemia-guided approach (medical management): Oral: Initial: 600 mg once at the time of diagnosis; followed by 75 mg once daily. Some experts prefer an initial dose of 600 mg unless there is high risk for bleeding, in which case, an initial dose of 300 mg is reasonable.
2-If using an invasive approach (reperfusion using percutaneous coronary intervention): Oral: Initial: 600 mg once as early as possible before PCI; followed by 75 mg once daily after PCI.
3-Duration of therapy: Preferred approach: Clopidogrel plus aspirin (DAPT) should be continued for ≥12 months unless major bleeding is a concern. For patients at high risk of bleeding or who experience overt bleeding, DAPT for 6 months may be reasonable, when DAPT is complete, discontinue clopidogrel and continue aspirin indefinitely for secondary prevention. Or the alternative approach in select patients to minimize bleeding events: Clopidogrel in combination with aspirin (DAPT) should be continued for 1 to 3 months after PCI, then discontinue aspirin and continue clopidogrel monotherapy. When clopidogrel is discontinued, restart aspirin for secondary prevention.
Side Effects
-Hemorrhage, angioedema, urticaria, maculopapular rash and thrombotic thrombocytopenic purpura (TTP).
-Hypotension, vasculitis, acute generalized exanthematous pustulosis, bullous rash, eczema, erythema multiforme, erythematous rash, exfoliative dermatitis, lichen planus, lichenoid eruption, maculopapular rash, pruritus, pustular psoriasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, colitis (including ulcerative colitis or lymphocytic colitis), diarrhea, duodenal ulcer, gastric ulcer, pancreatitis, stomatitis, acute hepatic failure, hepatitis, confusion, hallucination, headache, arthralgia, arthritis, myalgia, increased serum creatinine, bronchospasm, eosinophilic pneumonitis, interstitial pneumonitis and fever.
-Indication and usage(continue):
-Ischemic stroke/transient ischemic attack:
1-Secondary prevention in case of patients with intracranial atherosclerosis (50% to 99% stenosis of a major intracranial artery): Oral: 75 mg once daily in combination with aspirin; duration of clopidogrel depends on degree of stenosis and severity of stroke or TIA. Some experts recommend a loading dose of 300 to 600 mg once, followed by 75 mg once daily. If the stenosis is 50% to 69%: Clopidogrel may be added to aspirin for 21 days; after 21 days, discontinue clopidogrel and continue aspirin indefinitely. While if the stenosis is 70% to 99%: Clopidogrel may be added to aspirin for up to 90 days; after 90 days, discontinue clopidogrel and continue aspirin indefinitely.
2-Secondary prevention in case of patients with non-cardioembolic ischemic stroke or transient ischemic attack: Oral: 75 mg once daily indefinitely.
-Peripheral atherosclerotic disease (upper or lower extremity; with or without revascularization): Oral: 75 mg once daily.
Safety Advice
-Should not be given to patients suffering from hypersensitivity to clopidogrel.
-Should not be given to patients suffering from active pathological bleeding (eg, peptic ulcer, intracranial hemorrhage).
-Should not be given to patients suffering from significant liver impairment or cholestatic jaundice.
-Use with caution in patients with kidney impairment.
-Coronary artery stents: Premature interruption of therapy may result in stent thrombosis with subsequent fatal and nonfatal myocardial infarction. Duration of therapy, in general, is determined by the type of stent placed.
-Plasma concentrations of the main metabolite of clopidogrel were significantly higher in the elderly (≥75 years).
-Consumption of three 200 ml glasses of grapefruit juice a day may substantially reduce clopidogrel antiplatelet effects. So, avoid or minimize the consumption of grapefruit or grapefruit juice.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
-Store at room temperature.
-Indication and usage (continue):
-Percutaneous coronary intervention for stable ischemic heart disease: Oral: Initial: 600 mg once, administered ≥2 hours before PCI, ideally ≥24 hours before PCI; followed by 75 mg once daily. Duration of therapy: Upon completion of the recommended duration of DAPT (clopidogrel plus aspirin), discontinue clopidogrel and continue aspirin indefinitely:
1-Bare metal stent implantation: DAPT for at least 1 month. Some experts recommend at least 6 months.
2-Drug eluting stent implantation: DAPT for at least 6 months; if bleeding occurs or patient is at high risk of bleeding, may stop DAPT after 3 months.
3-Alternative approach in select patients to minimize bleeding events: DAPT should be continued for 1 to 3 months after PCI, then discontinue aspirin and continue clopidogrel monotherapy. When clopidogrel is discontinued, restart aspirin for long-term.
-Coronary artery bypass graft surgery:
1-In case of aspirin-allergic or aspirin-intolerant patients: Oral: 75 mg once daily; continue indefinitely. Some experts recommend a loading dose of 300 mg administered 6 hours after surgery, followed by 75 mg once daily.
2-Patients with acute coronary syndrome followed by coronary artery bypass graft surgery: Oral: 75 mg once daily in combination with aspirin for 1 year, then discontinue clopidogrel and continue aspirin indefinitely.
Drug Interactions
-Agents with antiplatelet properties (e.g. NSAIDs): May enhance the antiplatelet effect of other agents with antiplatelet properties.
-Amiodarone: May decrease serum concentrations of the active metabolite(s) of Clopidogrel.
-Anticoagulants: Agents with antiplatelet properties may enhance the anticoagulant effect of anticoagulants.
-Calcium channel blockers: May diminish the therapeutic effect of Clopidogrel.
-Desloratadine: May increase the serum concentration of Desloratadine.
-Erythromycin (Systemic): May diminish the antiplatelet effect of Clopidogrel.
-Esomeprazole: May diminish the antiplatelet effect of Clopidogrel.
-Grapefruit Juice: May decrease serum concentrations of the active metabolite(s) of Clopidogrel.
-Lansoprazole: May decrease serum concentrations of the active metabolite(s) of Clopidogrel.
-Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron): May enhance the antiplatelet effect of agents with antiplatelet properties.
-Omega-3 Fatty Acids: May enhance the antiplatelet effect of agents with antiplatelet properties.
-Omeprazole: May diminish the antiplatelet effect of Clopidogrel.
-Pantoprazole: May decrease serum concentrations of the active metabolite(s) of Clopidogrel.
-Pioglitazone: May increase the serum concentration of Pioglitazone.
-Rosuvastatin: Clopidogrel may increase the serum concentration of Rosuvastatin.
-Vitamin E (Systemic): May enhance the antiplatelet effect of agents with antiplatelet properties.
Pregnancy & Lactation
-Information related to use during pregnancy is limited. Based on available data, an increased risk of major birth defects, miscarriage, or adverse fetal outcomes has not been associated with maternal use of clopidogrel. Available guidelines recommend using clopidogrel only when strictly needed and for the shortest duration possible until additional fetal safety data are available.
-It is not known if clopidogrel is present in breast milk. Adverse events have not been reported in breastfed infants, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
-Ask your physician before taking any medication during pregnancy or lactation.
-Indication and usage (continue):
-Thromboprophylaxis in case of transcatheter aortic valve replacement: Oral: 300 mg once prior to valve implantation in combination with aspirin, followed by 75 mg once daily; may be used in combination with aspirin for 3 to 6 months depending on the type of valve implanted.
-Thromboprophylaxis in case of transcatheter mitral valve repair with MitraClip device: Oral: Loading dose: 300 mg once immediately following MitraClip insertion or within 24 hours prior to the procedure; may use as monotherapy or in combination with aspirin. Maintenance: 75 mg once daily for at least 6 months; may use as monotherapy or in combination with aspirin.
Manufacture
EUROPEAN EGYPTIAN PHARM. IND.
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