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Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up, Indocin Sale. Gastrointestinal Bleeding, Ulceration, And Perforation NSAIDs, including indomethacin, cause serious gastrointestinal GI adverse events including inflammation, Indocin sale, ulceration, and Indocin sale of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated Indocin sale NSAIDs.
Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors SSRIs ; smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients.
Use the lowest effective dosage for the shortest possible duration. Avoid use in patients at higher Indocin sale unless benefits are expected to outweigh the increased Indocin sale of bleeding. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of the Indocin sale signs and symptoms of hepatotoxicity e. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e.
Use of indomethacin may blunt the CV effects of several therapeutic agents used to treat these medical conditions e.
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Gastrointestinal Bleeding, Ulceration, And Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity e. Anaphylactic Reactions Inform patients of the signs of an anaphylactic Indocin sale e. Indomethacin produced no neoplastic or hyperplastic changes related to treatment in carcinogenic studies in the rat dosing period 73 to 110 weeks and the mouse dosing period 62 to 88 weeks at doses up to 1.
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When rat and mice dams were dosed during the last three days of gestation, indomethacin produced neuronal necrosis in the offspring at 0. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.
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In animal studies, NSAIDs, including indomethacin, inhibit Indocin sale synthesis, Indocin sale delayed parturition, and increase the incidence of stillbirth. Data Animal data Reproductive studies were conducted in mice and rats at dosages of 0. Lactation Risk Summary Based on available published clinical data, indomethacin may be present in human milk.