Ketorolac Trometamol 30 mg/ml solution for injection – Summary of Product Characteristics (SmPC) – (emc)

Video Ketorolac what is it used for

ketorolac: Epidemiological evidence suggests that ketorolac may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially when used off-label and/or during prolonged periods (see also section 4.1, 4.2 and 4.3).

Physicians should be aware that in some patients, pain relief may not occur for more than 30 minutes after intravenous or intramuscular administration.

The use of ketorolac with concomitant NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

undesirable effects can be minimized by using the lowest effective dose for the shortest time necessary to control symptoms (see section 4.2 and cardiovascular and gi risks below).

ulcer, bleeding and gastrointestinal perforation:

Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs, including ketorolac therapy, at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.

In a post-marketing, non-randomized, hospital-based surveillance study, increased rates of clinically serious gastrointestinal bleeding were observed in patients < 65 years of age who received an average daily dose of > IM ketorolac 90 mg compared to patients receiving parenteral opioids.

The elderly have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. debilitated patients seem to tolerate ulceration or bleeding less than others. the majority of fatal gastrointestinal events associated with nonsteroidal anti-inflammatory drugs occurred in elderly and/or debilitated patients. The risk of gastrointestinal bleeding, ulceration, or perforation is greater with increasing doses of NSAIDs, including IV ketorolac, in patients with a history of ulcer, especially if complicated by bleeding or perforation, and in the elderly. the risk of clinically serious gastrointestinal bleeding is dose dependent. these patients should start treatment with the lowest dose available. Combination therapy with protective agents (eg, misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients who require concomitant low-dose aspirin or other medications that may increase gastrointestinal risk ( see section 4.5). This age-related risk of gastrointestinal bleeding and perforation is common to all NSAIDs. Compared to young adults, the elderly have an increased plasma half-life and reduced plasma clearance of ketorolac. a longer dosing interval is recommended (see section 4.2).

NSAIDs should be used with caution in patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may be exacerbated (see section 4.8). patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly early in treatment. when gastrointestinal bleeding or ulceration occurs in patients receiving IV ketorolac, treatment should be discontinued.

Caution should be exercised in patients receiving concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).

It is contraindicated for use in patients taking anticoagulants such as warfarin (see section 4.3).

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As with other NSAIDs, the incidence and severity of gastrointestinal complications may increase with increasing dose and duration of IV ketorolac therapy. the risk of clinically serious gastrointestinal bleeding is dose dependent. this is particularly true in elderly patients receiving an average daily dose greater than 60 mg/day of IV ketorolac. a history of peptic ulcer disease increases the chance of developing serious gastrointestinal complications during ketorolac therapy.

hematological effects:

Patients with coagulation disorders should not receive ketorolac trometamol 30 mg/ml solution for injection. Patients on anticoagulant therapy may be at increased risk of bleeding if ketorolac trometamol 30 mg/ml solution for injection is co-administered. Concomitant use of ketorolac and prophylactic low dose heparin (2,500 – 5,000 units every 12 hours) and dextrans has not been extensively studied and may also be associated with an increased risk of bleeding. patients already taking anticoagulants or requiring low doses of heparin should not receive ketorolac. Patients receiving other drug therapy that interferes with haemostasis should be carefully observed if Ketorolac Trometamol 30mg/ml Injection is administered. In controlled clinical studies, the incidence of clinically significant postoperative bleeding was less than 1%.

ketorolac inhibits platelet aggregation and prolongs bleeding time. in patients with normal bleeding function, bleeding times were elevated, but not outside the normal range of two to eleven minutes. Unlike the long-term effects of aspirin, platelet function returns to normal within 24 to 48 hours after ketorolac is stopped.

In post-marketing experience, postoperative wound bleeding has been reported in association with the perioperative use of ketorolac trometamol 30 mg/ml solution for injection im/iv. therefore, ketorolac should not be used in patients who have had operations with a high risk of bleeding or incomplete hemostasis. caution should be exercised when strict hemostasis is critical, e.g. in cosmetic or outpatient surgery, prostate resection or tonsillectomy. Bruising and other signs of bleeding from wounds and epistaxis have been reported with the use of ketorolac trometamol 30 mg/ml solution for injection. Physicians should be aware of ketorolac’s pharmacological similarity to other nonsteroidal anti-inflammatory drugs that inhibit cyclooxygenase and the risk of bleeding, especially in the elderly.

skin reactions

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at greatest risk of these reactions early in the course of therapy: the onset of reactions occurs in most cases within the first month of treatment. Ketorolac trometamol 30 mg/ml solution for injection should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

sle and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).

sodium/fluid retention in cardiovascular conditions and peripheral edema

Caution is required in patients with a history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with NSAID therapy.

Fluid retention, hypertension, and peripheral edema have been observed in some patients taking NSAIDs, including ketorolac, and should therefore be used with caution in patients with cardiac decompensation, hypertension, or similar conditions.

cardiovascular and cerebrovascular effects

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Patients with a history of hypertension and/or mild to moderate congestive heart failure require appropriate follow-up and counseling as fluid retention and edema have been reported in association with NSAID treatment.

Clinical trials and epidemiological data suggest that the use of coxibs and some NSAIDs (particularly at high doses) may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke). Although ketorolac has not been shown to increase thrombotic events such as myocardial infarction, there are insufficient data to exclude such a risk for ketorolac.

Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketorolac after careful evaluation. A similar consideration should be made before initiating treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking).

cardiovascular, renal and hepatic insufficiency:

Caution should be exercised in patients with conditions leading to reduced renal blood volume and/or blood flow, where renal prostaglandins have a supportive role in maintaining renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in renal prostaglandin formation and may precipitate overt renal failure. Patients most at risk for this reaction are those who are volume depleted due to blood loss or severe dehydration, patients with renal insufficiency, heart failure, liver dysfunction, the elderly, and those taking diuretics. renal function should be monitored in these patients. discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. Inadequate fluid/blood replacement during surgery, leading to hypovolaemia, may lead to renal dysfunction which may be exacerbated when ketorolac trometamol 30 mg/ml solution for injection is administered. therefore, volume depletion should be corrected, and close monitoring of serum urea and creatinine and urine output is recommended until the patient is normovolemic. In renal dialysis patients, ketorolac clearance was reduced to approximately half the normal rate and the terminal half-life was increased approximately threefold (see section 4.3).

kidney effects:

As with other NSAIDs, ketorolac should be used with caution in patients with impaired renal function or a history of renal disease because it is a potent inhibitor of prostaglandin synthesis. Caution should be exercised as renal toxicity has been observed with ketorolac and other NSAIDs in patients with conditions leading to reduced renal blood volume and/or blood flow in which renal prostaglandins play a supportive role in maintaining renal function. renal perfusion.

In these patients, administration of ketorolac or other NSAIDs may cause a dose-dependent reduction in renal prostaglandin formation and may precipitate overt renal decompensation or failure. Patients most at risk for this reaction are those with renal failure, hypovolemia, heart failure, liver dysfunction, those taking diuretics, and the elderly. discontinuation of ketorolac or other nonsteroidal anti-inflammatory therapy is usually followed by recovery to pretreatment status.

As with other drugs that inhibit prostaglandin synthesis, elevations in serum urea, creatinine, and potassium have been reported with ketorolac trometamol and may occur after one dose.

patients with renal insufficiency: since ketorolac trometamol and its metabolites are mainly excreted via the kidneys, patients with moderate to severe renal insufficiency (serum creatinine greater than 160 micromol/l) should not receive ketorolac trometamol 30 mg/ml solution for injection. patients with minor renal insufficiency should receive a reduced dose of ketorolac (not to exceed 60 mg/day im or iv) and their renal status should be closely monitored.

Use in patients with impaired liver function: Patients with impaired liver function due to cirrhosis do not have clinically important changes in ketorolac clearance or terminal half-life.

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Borderline elevations of one or more liver function tests may occur. these abnormalities may be transient, may remain unchanged, or may progress with continued therapy. Significant elevations (greater than 3 times normal) in serum glutamate pyruvate transaminase (sgpt/alt) or serum glutamate oxaloacetate transaminase (sgot/ast) occurred in controlled clinical trials in less than 1% of patients. if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, ketorolac trometamol 30 mg/ml solution for injection should be discontinued.

anaphylactic (anaphylactoid) reactions

Anaphylactic (anaphylactoid) reactions (including, but not limited to, anaphylaxis, bronchospasm, flushing, rash, hypotension, laryngeal edema, and angioedema) may occur in patients with or without a history of hypersensitivity to aspirin, other NSAIDs, or IV ketorolac. . these may also occur in individuals with a history of angioedema, bronchospastic reactivity (eg, asthma), and nasal polyps. anaphylactoid reactions, such as anaphylaxis, can be fatal. therefore, ketorolac should be used with caution in patients with a history of asthma and in patients with complete or partial syndrome of nasal polyps, angioedema, and bronchospasm.

precautions related to fertility

The use of ketorolac trometamol 30 mg/ml solution for injection, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may affect fertility and is not recommended in women trying to conceive. In women who have difficulty conceiving or who are undergoing fertility investigation, ketorolac trometamol suspension 30 mg/ml solution for injection should be considered.

fluid retention and edema

Fluid retention, hypertension, and edema have been reported with the use of ketorolac and therefore should be used with caution in patients with cardiac decompensation, hypertension, or similar conditions.

Caution is advised when co-administering methotrexate, as some prostaglandin synthesis inhibitor drugs have been reported to reduce clearance of methotrexate and thus possibly increase its toxicity.

pediatric use:

ketorolac tablets are not recommended for use in children. parenterally administered ketorolac is not recommended in children under 2 years of age.

drug abuse and dependence

ketorolac has no addictive potential. no withdrawal symptoms have been observed after abrupt discontinuation of iv ketorolac.

Content Creator Zaid Butt joined Silsala-e-Azeemia in 2004 as student of spirituality. Mr. Zahid Butt is an IT professional, his expertise include “Web/Graphic Designer, GUI, Visualizer and Web Developer” PH: +92-3217244554

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