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Clopidogrel, sold under the brand name Plavix among others, is an antiplatelet medication used to reduce the risk of heart disease and stroke in those at high risk. [10] It is also used together with aspirin in heart attacks and following the placement of a coronary artery stent (dual antiplatelet therapy). [10] It is taken by mouth. [10]
How Supplied - includes the dosage form(s), strength(s), units in which the dosage form(s) are ordinarily available, identifying features of the dosage form(s) such as the National Drug Code (NDC), and special handling and storage conditions (e.g., "Store between 68 and 78°F ")
Side effects may include bleeding, most commonly from the nose, gastrointestinal tract (GI) or genitourinary system. [2] Compared to the risk of bleeding with warfarin use, direct factor Xa inhibitors have a higher risk of GI bleeding, but lower risk of bleeding in the brain. [2]
0–10 0–33 Unnoticeable small symptoms, or no symptoms at all; 2–4 10–30 33–100 Mild impairment of performance of unpracticed tasks; Mildly impaired reasoning; Mild euphoria possible; 4–6 30–50 100–165 Delayed response to visual and auditory stimuli; Reasoning and immediate memory affected more than motor coordination
Auxiliary labels can commonly be misinterpreted, especially when multi-step or multi-part instructions are present on one label. [5] Misinterpretation of auxiliary labels can occur when patients are unable to understand the wording of the label, and thus assume an instruction based on the pictogram or color of the label. [ 5 ]
Precautionary statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). [1] They are intended to form a set of standardized phrases giving advice about the correct handling of chemical substances and mixtures, which can be translated into different languages.
For an ANDA to be approved, the FDA requires that the 90% confidence interval of the geometric mean test/reference ratios for the total drug exposure (represented by the area under the curve or AUC) and the maximum plasma concentration (Cmax) should fall within limits of 80–125%. [42] (This range is part of a statistical calculation, and does ...
An antiplatelet drug (antiaggregant), also known as a platelet agglutination inhibitor or platelet aggregation inhibitor, is a member of a class of pharmaceuticals that decrease platelet aggregation [1] and inhibit thrombus formation.