Valdon

Secondary prevention of atherothrombotic events in: Adults suffering from MI (from a few days until <35 days), ischemic stroke (from 7 days until <6 mth), or established peripheral arterial disease; adults suffering from acute coronary syndrome: non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI), including patients undergoing stent placement following percutaneous coronary intervention combined w/ ASA; ST segment elevation acute MI combined w/ ASA in medically treated patients eligible for thrombolytic therapy. In combination w/ ASA in adults w/ moderate to high-risk transient ischemic attack (TIA) (ABCD2 score ≥4) or minor ischemic stroke (IS) (NIHSS ≤3) w/in 24 hr of the TIA or IS event. Prevention of atherothrombotic & thromboembolic events in atrial fibrillation in combination w/ ASA.

Adult & elderly 75 mg as single daily dose. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) 300 or 600 mg loading dose. Consider 600-mg loading dose in patients <75 yr when percutaneous coronary intervention is intended. Continue clopidogrel treatment at 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI 75 mg as single daily dose initiated w/ 300 mg loading dose in combination w/ ASA w/ or w/o thrombolytics. Initiate w/o loading dose in medically treated patients >75 yr. Moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) 300 mg loading dose, followed by 75 mg once daily & ASA (75-100 mg once daily). Start treatment w/in 24 hr of the event & continue for 21 days followed by single antiplatelet therapy. Atrial fibrillation 75 mg as single daily dose, combined w/ ASA (75-100 mg daily).

May be taken with or without food.

Hypersensitivity. Severe hepatic impairment. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage.

Patients at risk of increased bleeding from trauma, surgery, or other pathological conditions & patients receiving treatment w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors, NSAIDs (including COX-2 inhibitors), SSRIs, CYP2C19 strong inducers, or other medicinal products associated w/ bleeding risk (eg, pentoxifylline); patients w/ lesions w/ propensity to bleed (particularly GI & intraocular); w/ renal impairment or moderate hepatic disease who may have bleeding diatheses; poor CYP2C19 metabolizers. Not recommended to be co-administered w/ oral anticoagulants. Discontinue 7 days prior to elective surgery if antiplatelet is temporarily not desirable. Reports of acquired hemophilia. Very rare reports of TTP. 600-mg loading dose is not recommended in patients w/ non-ST segment elevation acute coronary syndrome & ≥75 yr of age. Dual antiplatelet therapy (DAPT) is not recommended in non-minor IS patients (NIHSS >4), patients for whom treatment w/ carotid endarterectomy or intravascular thrombectomy is indicated, or in patients planned for thrombolysis or anticoagulant therapy. Initiate clopidogrel monotherapy in non-minor IS patients only after the 1st 7 days of the event. Avoid concomitant use of strong or moderate CYP2C19 inhibitors & strong CYP2C19 inducers. Caution in patients treated concomitantly w/ CYP2C8 substrate medicinal products. Reports of cross-reactivity among thienopyridines (eg, clopidogrel, ticlopidine, prasugrel). Contains lactose; patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Contains hydrogenated castor oil which may cause stomach upset & diarrhoea. Not to be used in childn. Preferable not to use during pregnancy. Discontinue breastfeeding during treatment.

Hematoma; epistaxis; GI hemorrhage, diarrhea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.

Increased risk of bleeding w/ oral anticoagulants (eg, warfarin); glycoprotein IIb/IIIa inhibitors; ASA; heparin; thrombolytics; NSAIDs; SSRIs. Increased drug levels of active metabolite of clopidogrel w/ CYP2C19 inducers (eg, rifampicin). Reduced drug levels of the active metabolite of clopidogrel w/ CYP2C19 inhibitors (eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz). Ave platelet inhibition can be decreased w/ ritonavir. Increased exposure of repaglinide & other drugs primarily cleared by CYP2C8 metabolism; rosuvastatin. Opioid agonists has the potential to delay & reduce clopidogrel absorption.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.

Rx