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boxed warning
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings andPrecautions ( 5.1 ) ]. Indomethacin extended-release capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.1 ) Indomethacin extended-release capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 )
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms ofhepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension : Patients taking some antihypertensive medicationsmay have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of indomethacin extended-release capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of indomethacin extended-release capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylacticreaction occurs ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Indomethacin extended-release capsules are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (withoutaspirin sensitivity) ( 5.8 ) Serious Skin Reactions : Discontinue indomethacin extended-releasecapsules at first appearance of skin rash or other signs of hyper-sensitivity ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue and evaluate clinically ( 5.10 ) Fetal Toxicity : Limit use of NSAIDs, including indomethacin extended- release capsules, between about 20 to 30 weeks in pregnancy dueto the risk of oligohydramnios/fetal renal dysfunction. Avoid use ofNSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.11 , 8.1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patientswith any signs or symptoms of anemia ( 5.12 , 7 ) 5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years dur2ation have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative inc...
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] Most common adverse reactions (incidence ≥ 3%) are headache, dizziness, dyspepsia and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-800-862-3895 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving indomethacin immediate-release capsules than in the group taking indomethacin suppositories or placebo. In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with indomethacin immediate-release capsules or suppositories was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group. The adverse reactions for indomethacin immediate-release capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between indomethacin and these adverse reactions, some of which hav...
adverse reactions table
Incidence greater than 1%Incidence less than 1%GASTROINTESTINALnausea* with orwithout vomiting dyspepsia* (includingindigestion, heartburn and epigastric pain)diarrheaabdominal distress or pain constipationanorexiabloating (includes distension) flatulencepeptic ulcer gastroenteritis rectal bleeding proctitissingle or multiple ulcerations,including perforation and hemorrhage of the esophagus, stomach, duodenum or small and large intestinesintestinal ulceration associated with stenosis and obstructiongastrointestinal bleeding without obvious ulcer formation and perforation of preexisting sigmoid lesions (diverticulum, carcinoma, etc.) development of ulcerative colitis and regional ileitisulcerative stomatitistoxic hepatitis and jaundice (some fatal cases have been reported)intestinal strictures (diaphragms)pancreatitisCENTRAL NERVOUS SYSTEMheadache (11.7%) dizziness*vertigo somnolencedepression and fatigue (including malaise and listlessness)anxiety (includes nervousness) muscle weaknessinvoluntary muscle movements insomniamuzzinesspsychic disturbances including psychotic episodesmental confusion drowsinesslight-headedness syncope paresthesiaaggravation of epilepsy and parkinsonismdepersonalization comaperipheral neuropathy convulsiondysarthriaSPECIAL SENSEStinnitusocular - corneal deposits and retinal disturbances, including those of the macula, have been reported insome patients on prolonged therapy with indomethacinblurred vision diplopiahearing disturbances, deafnessCARDIOVASCULARNonehypertension hypotension tachycardia chest paincongestive heart failure arrhythmia; palpitationsMETABOLICNoneedema weight gainfluid retention flushing or sweatinghyperglycemia glycosuria hyperkalemiaINTEGUMENTARYnonepruritusrash; urticariapetechiae or ecchymosisexfoliative dermatitis erythema nodosum loss of hairStevens-Johnson syndrome erythema multiformetoxic epidermal necrolysisHEMATOLOGICNoneleukopeniabone marrow depressionanemia secondary to obvious or occult gastrointestinal bleedingaplastic anemia hemolytic anemia agranulocytosisthrombocytopenic purpura disseminated intravascularcoagulationHYPERSENSITIVITYNoneacute anaphylaxisacute respiratory distressrapid fall in blood pressure resemblinga shock-like stateangioedemadyspnea asthma purpura angiitispulmonary edema feverGENITOURINARYNonehematuriavaginal bleeding proteinurianephrotic syndrome interstitial nephritisBUN e...