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FC tab: Cardiovascular effects: Cardiovascular thrombotic events: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or 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. The concurrent use of Aspirin and an NSAID does increase the risk of serious GI events (see Gastrointestinal effects as follows).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see Contraindications).
Hypertension: NSAIDs, including Dexketoprofen Trometamol, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Dexketoprofen Trometamol, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Congestive heart failure and edema: Fluid retention and edema have been observed in some patients taking NSAIDs. Dexketoprofen Trometamol, should be used with caution in patients with fluid retention or heart failure.
Gastrointestinal effects-risk of ulceration, bleeding, and perforation: NSAIDs, including Dexketoprofen Trometamol, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the 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 with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a grater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
The drug should be used with caution in patients with a history of allergic conditions, esophagitis, and gastritis.
The drug should be used with caution in patients who may be adversely affected by a prolongation of bleeding time (e.g., patients receiving anticoagulant therapy), since the drug may inhibit platelet function.
Like other NSAIDs, urea nitrogen and creatinine plasma level may increase. Some NSAIDs have been associated with nephrotoxicity such as glomerulonephritis, interstitial nephritis and nephrotic syndrome. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.
Elevations of serum SGPT or SGOT concentration have occurred in patients receiving NSAIDs. Therapy should be discontinued if signs or symptoms of a severe hepatic reaction occur.
The drug should be used with caution in patients with hematopoietic disorders, systemic lupus erythematosus, or mixed-type of connective tissue disease. The use of NSAIDs may mask the usual signs and symptoms of infection or other diseases.
The drug is not recommended in patients with advanced renal disease. If the drug is used in patients with severe renal impairment, close monitoring of renal function is recommended.
The safety of the drug in children has not been established.
NSAIDs should be used with caution in the geriatric patients and may need to be given in reduced doses. Geriatric patients appear to tolerate gastrointestinal ulceration or bleeding less well than other individuals. The recent use of NSAIDs in geriatric patients has been associated with an increased risk of developing heart failure.
Inj: The safety of its use in children has not been established.
Caution in patients with a history of drug allergy and bronchial asthma.
Patients with diseases of the gastrointestinal symptoms should be monitored, specifically the gastrointestinal bleeding. If bleeding or gastrointestinal peptic occur, treatment must be discontinued immediately.
As with other NSAIDs, it could potentially inhibit aggregation of platelets and prolong bleeding time through the inhibition of prostaglandins synthesis. Concomitant use of Dexketoprofen Trometamol with preventive dose of lower molecular weight of Heparin in postoperative shows that there is no effect for the coagulation parameter that already determined. However, the patients who have other therapy that affect hemostasis should be monitored carefully.
Increase of urea nitrogen and plasma creatinine can happen like other NSAIDs. As inhibitors of prostaglandin synthesis, side effects can occur in the renal system: glomerulonephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure.
As with other NSAIDs, these drugs can increase liver enzymes (temporary), if occur a significant increase in SGPT and SGOT, discontinue therapy immediately. Caution in patients with hematopoietic disorders, systemic lupus erythematosus, or a mixed connective tissue disease. The use of NSAIDs may mask the symptoms of the infection.
Caution in patients with impaired liver function, kidney or heart failure and other conditions that would cause fluid retention. In these patients, NSAID treatment can decrease kidney function and fluid retention. Caution in patients that already have diuretic therapy or hypovolemia incidence that can increase nephrotoxicity risk.
Caution in elderly patients, are more susceptible to side effects: gastrointestinal bleeding and/or perforation, depending on the doses. While therapy, sometimes it can be more serious and occurring without warning or previous history. In elderly patients, the risk of kidney, cardiovascular and liver damage is increasing so their function should be monitored.
