Clopidogrel Bisulfate Tablet, Film Coated
Product Images NDC 47335-894

The text is a figure caption that shows fatal or nonfatal vascular events and the cumulative event rate of patients in the CAPRIE study who either took aspirin or clopidogrel. It also shows the duration of follow-up in months.*

The text presents a figure titled "Figure 8: Hazard Ratio and 95% CI by Baseline Subgroups in the CAPRIE Study." The figure compares the hazard ratio and confidence intervals of patients receiving Clopidogrel and Aspirin by baseline subgroups, including Stk and PAD. The data shows favor for Clopidogrel in terms of hazard ratio for Stk patients but not for PAD patients. The overall results of the study show a slightly higher hazard ratio for Aspirin. The values of the hazard ratio and CI are not provided.*

The figure shows the exposure of the Clopidogrel active metabolite after taking multiple doses of Clopidogrel 75mg with and without Proton Pump Inhibitors (PPIs), including Dexlansoprazole (60mg), Lansoprazole (30mg), Pantoprazole (80mg), and Omeprazole (80mg). The graph also shows the coadministered PPI effect on active metabolite AUC in mean and 90% confidence intervals. There is a change relative to the administration of Clopidogrel alone.*

The text describes the results of the CURE Study with figures showing the cumulative event rate of cardiovascular death, myocardial infarction, and stroke in patients on placebo and those on clopidogrel in addition to aspirin. The study findings suggest that the combination of clopidogrel and aspirin may be more effective in reducing the incidence of these events. Standard therapies were also used as appropriate during the study period.*

The text describes a figure showing cumulative event rates for a combined endpoint of re-infarction, stroke, or death in the COMMIT study. The figure shows the percentages of patients with the combined endpoint before first discharge, and the days since randomization up to 28 days. All treated patients received aspirin. The results show that for the placebo group, 10.1% had events, while for the clopidogrel group, it was 9.2% resulting in a 9% proportional risk reduction (p value=0.002) for clopidogrel treatment.*

Each tablet of Clopidogrel Tablets, USP contains 97.875mg of clopidogrelbisulfate, USP equivalent to 1075mg of clopidogrelbase. The usual adult dosage is mentioned in the package insert. The tablets should be stored between 20°C to 25°C (68°F to 77°F), with permitted excursions between 15°C to 30°C (59°F to 86°F) as per USP controlled room temperature. It is a prescription drug, distributed by Sun Pharmaceutical Industries Inc. and manufactured by Sun Pharmaceutical Industries Ltd. The tablets come in a well-closed container as per USP standards. The NDC number is 47335-894-19. It is essential to dispense the medication guide separately to each patient by the pharmacist for the correct usage of the drug.*