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nausea* with or without vomiting dyspepsia* (including indigestion, heartburn and epigastric pain) diarrhea abdominal distress or pain constipation |
anorexia bloating (includes distension) flatulence peptic ulcer gastroenteritis rectal bleeding proctitis single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum or small and large intestines intestinal ulceration associated with stenosis and obstruction |
gastrointestinal bleeding without obvious ulcer formation and perforation of preexisting sigmoid lesions (diverticulum, carcinoma, etc.) development of ulcerative colitis and regional ileitis ulcerative stomatitis toxic hepatitis and jaundice (some fatal cases have been reported) intestinal strictures (diaphragms) |
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headache (11.7%) dizziness* vertigo somnolence depression and fatigue (including malaise and listlessness) |
anxiety (includes nervousness) muscle weakness involuntary muscle movements insomnia muzziness psychic disturbances including psychotic episodes mental confusion drowsiness |
light-headedness syncope paresthesia aggravation of epilepsy and parkinsonism depersonalization coma peripheral neuropathy convulsion dysarthria |
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tinnitus | ocular — corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients on prolonged therapy with indomethacin capsules |
blurred vision diplopia hearing disturbances, deafness |
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None | hypertension hypotension tachycardia chest pain |
congestive heart failure arrhythmia; palpitations |
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None | Edema weight gain fluid retention flushing or sweating |
hyperglycemia glycosuria hyperkalemia |
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none | Pruritus rash; urticaria petechiae or ecchymosis |
exfoliative dermatitis erythema nodosum loss of hair Stevens-Johnson syndrome erythema multiforme toxic epidermal necrolysis |
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None | Leucopenia bone marrow depression anemia secondary to obvious or occult gastrointestinal bleeding |
aplastic anemia hemolytic anemia agranulocytosis thrombocytopenic purpura disseminated intravascular coagulation |
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None | acute anaphylaxis acute respiratory distress rapid fall in blood pressure resembling a shock-like state angioedema |
dyspnea asthma purpura angiitis pulmonary edema fever |
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None | hematuria vaginal bleeding proteinuria nephrotic syndrome interstitial nephritis |
BUN elevation renal insufficiency, including renal failure |
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None | epistaxis breast changes, including enlargement and tenderness, or gynecomastia |
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*Reactions occurring in 3% to 9% of patients treated with indomethacin capsules. (Those reactions occurring in less than 3% of the patients are unmarked.) |
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Monitor patients with concomitant use of indomethacin with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ |
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Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ |
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Concomitant use of indomethacin and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ Indomethacin capsule is not a substitute for low dose aspirin for cardiovascular protection. |
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Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. It has been reported that the addition of triamterene to a maintenance schedule of indomethacin resulted in reversible acute renal failure in two of four healthy volunteers. Indomethacin and triamterene should not be administered together. Both indomethacin capsules and potassium-sparing diuretics may be associated with increased serum potassium levels. The potential effects of indomethacin and potassium-sparing diuretics on potassium levels and renal function should be considered when these agents are administered concurrently. |
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Indomethacin and triamterene should not be administered together. During concomitant use of indomethacin capsules with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects. Be aware that indomethacin and potassium-sparing diuretics may both be associated with increased serum potassium levels [ |
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The concomitant use of indomethacin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. |
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During concomitant use of indomethacin capsules and digoxin, monitor serum digoxin levels. |
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NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance |
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During concomitant use of indomethacin capsules and lithium, monitor patients for signs of lithium toxicity. |
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Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
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During concomitant use of indomethacin capsules and methotrexate, monitor patients for methotrexate toxicity. |
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Concomitant use of indomethacin and cyclosporine may increase cyclosporine’s nephrotoxicity. |
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During concomitant use of indomethacin and cyclosporine, monitor patients for signs of worsening renal function. |
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Concomitant use of indomethacin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ Combined use with diflunisal may be particularly hazardous because diflunisal causes significantly higher plasma levels of indomethacin. [see In some patients, combined use of indomethacin and diflunisal has been associated with fatal gastrointestinal hemorrhage. |
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The concomitant use of indomethacin with other NSAIDs or salicylates, especially diflunisal, is not recommended. |
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Concomitant use of indomethacin and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
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During concomitant use of indomethacin and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. |
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When indomethacin is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased. |
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During the concomitant use of indomethacin and probenecid, a lower total daily dosage of indomethacin may produce a satisfactory therapeutic effect. When increases in the dose of indomethacin are made, they should be made carefully and in small increments. |