Indocin 75 mg En Belgique
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Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians: Although needtesr.000webhostapp.com have been several reports of leukemiathe supporting information is weak Genitourinary: Drug Interactions See Table 2 for clinically significant drug Indocin 75 mg ens Belgique with indomethacin, Indocin 75 mg En Belgique.
Indomethacin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of indomethacin and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
In patients who are elderly, volume-depleted including those on diuretic therapyor have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible. When these drugs are administered concomitantly, Indocin 75 mg ens Belgique should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics e. It has been reported that the addition of triamterene to a maintenance schedule of INDOCIN SR resulted in reversible acute renal failure in two of four healthy volunteers.
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The potential effects of INDOCIN SR and potassium-sparing diuretics on potassium levels and renal function should be considered when these agents are administered concurrently. Indomethacin and triamterene should not be administered together, Indocin 75 mg En Belgique. During concomitant use of INDOCIN SR with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.
The concomitant use of indomethacin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. Combined use with diflunisal may be particularly hazardous because diflunisal Indocin 75 mg ens Belgique significantly higher plasma levels of indomethacin. In some patients, combined use of indomethacin and diflunisal has been associated with fatal gastrointestinal hemorrhage.
The concomitant use of indomethacin with other NSAIDs or salicylates, especially diflunisal, is not recommended. NSAIDs with short elimination half-lives e. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives e. When indomethacin is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased.
When increases in the dose of indomethacin are made, they should be made carefully and in small increments.
These facts should be considered when evaluating plasma renin activity in hypertensive patients.
False-negative results in the dexamethasone suppression test DST in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate, Indocin 75 mg En Belgique. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses.
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To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. 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.
Gastrointestinal Bleeding, Ulceration, And Perforation NSAIDs, including indomethacin, cause serious gastrointestinal GI adverse events including inflammation, bleeding, ulcerationand perforation of the esophagusstomach, small intestineor large intestinewhich can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Other factors that increase the risk of GI bleeding in patients treated Indocin 75 mg en Belgique 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, Indocin 75 mg En Belgique. Use the lowest Indocin 75 mg en Belgique dosage for the shortest possible duration. Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding.
In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitisliver necrosisand hepatic failure have been reported. Inform patients of the warning signs and symptoms of hepatotoxicity e.
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If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. Use of indomethacin may blunt the CV Indocin 75 mg ens Belgique of several therapeutic agents used to treat these medical conditions e.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemiaheart failure, Indocin 75 mg En Belgique, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly.
It has been reported that the addition of the potassium -sparing diuretictriamtereneto a maintenance schedule of indomethacin resulted in reversible acute renal failure in two of four healthy volunteers. Hyperkalemia Increases in serum potassium concentration, including hyperkalemiahave been reported with use of NSAIDs, even in some patients without renal impairment.
In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. Both Indomethacin and potassium-sparing diuretics may be associated with increased Indocin 75 mg en Belgique potassium levels.
The potential effects of indomethacin and potassium-sparing diuretics on potassium levels and renal function should be considered Indocin 75 mg en Belgique these agents are administered concurrently. Seek emergency help if an anaphylactic reaction occurs. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of INDOCIN SR at the first appearance of skin rash or any other sign of hypersensitivity.
This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.
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Co-morbid conditions, such as coagulation disorders, or concomitant use of warfarin, other anticoagulants, antiplatelet agents e. INDOCIN SR may cause drowsiness; therefore, caution patients about engaging in activities requiring mental alertness and motor coordination, such as driving a car.
Indomethacin may also cause headache. It is advisable to discontinue therapy if such changes are observed. Blurred vision may be a significant symptom and warrants a thorough ophthalmological examination. Since these Indocin 75 mg ens Belgique may be asymptomaticophthalmologic examination at periodic intervals is desirable in patients receiving prolonged therapy, Indocin 75 mg En Belgique.
Indomethacin produced no neoplastic or hyperplastic changes related to treatment in carcinogenic studies in the rat dosing period 73 to weeks and the mouse dosing period 62 to 88 weeks at doses up to 1. Mutagenesis Indomethacin did not have any mutagenic effect in in vitro bacterial tests and a series of in vivo tests including the host-mediated assay, sex-linked recessive lethals in Drosophilaand the micronucleus test in mice.
Impairment Of Fertility Indomethacin at dosage levels up to 0. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling Medication Guide that accompanies each prescription dispensed.
Inform patients, families, or their caregivers of the following information before initiating therapy with INDOCIN SR and periodically during the course of ongoing therapy.
Gastrointestinal Bleeding, Ulceration, And Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsiamelenaIndocin 75 mg En Belgique, 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 reaction e.
Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.
In the general U. In animal reproduction studies retarded fetal ossification was observed with administration of indomethacin to mice and rats during organogenesis at doses 0.
In published studies in pregnant mice, indomethacin produced maternal toxicity and death, increased fetal resorptions, and fetal malformations at 0. 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 implantationand decidualization. In animal studies, Indocin 75 mg En Belgique, administration of prostaglandin synthesis inhibitors such as indomethacin, Indocin 75 mg En Belgique, resulted in increased pre- and post-implantation loss. In animal studies, NSAIDs, including indomethacin, inhibit prostaglandin synthesis, cause delayed parturitionand increase the incidence of stillbirth.
Data Animal data Reproductive studies were conducted in mice and rats at dosages of 0. In rats and mice, maternal indomethacin administration of 4. Lactation Risk Summary Based on available published clinical data, indomethacin may be present in human milk. Based on these levels, the average concentration present in breast milk was estimated to be 0. In another study indomethacin levels were measured in breast milk of eight postpartum women using doses of 75 mg daily and the results were used to calculate an estimated infant daily dose.
Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation.
Pediatric Use Safety and effectiveness in pediatric patients 14 years of age and younger has not been established. INDOCIN SR should not be prescribed for pediatric patients 14 years of age and younger unless toxicity or lack of efficacy associated with other drugs warrants the risk.
In experience with more than pediatric patients reported in the literature or to the manufacturer who were treated with indomethacin immediate-release capsules, side effects in pediatric Indocin 75 mg ens Belgique were comparable to those reported in adults.
Experience in pediatric patients has been confined to the use of indomethacin immediate-release capsules, Indocin 75 mg En Belgique. If a decision is made to use indomethacin for pediatric patients two years of age or older, such patients should be monitored closely and periodic assessment of liver function is recommended. There have been cases of hepatotoxicity reported in pediatric patients with juvenile rheumatoid arthritisincluding fatalities. As symptoms subside, the total daily dosage should be reduced to the lowest level required to control symptoms, or the drug should be discontinued.
Indomethacin may cause confusion or rarely, psychosis [see ADVERSE REACTIONS ]; physicians should remain alert to the possibility of such adverse Indocin 75 mg ens Belgique in the elderly Indomethacin and its metabolites are known to be substantially excreted by the kidneys, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Gastrointestinal bleeding has occurred. There are no specific antidotes. Forced diuresisalkalinization of urine, hemodialysisor hemoperfusion may not be useful due to high protein binding.
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