PRODUCT MONOGRAPH. (Ketorolac Tromethamine) Sterile Solution. 30 mg/ml. Non-Steroidal Anti-Inflammatory Drug (NSAID)

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1 PRODUCT MONOGRAPH Pr KETOROLAC TROMETHAMINE INJECTION USP (Ketorolac Tromethamine) Sterile Solution 30 mg/ml Non-Steroidal Anti-Inflammatory Drug (NSAID) Pfizer Canada Inc Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: December 1, 2017 Submission Control No:

2 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION...3 SUMMARY PRODUCT INFORMATION...3 INDICATIONS AND CLINICAL USE...3 CONTRAINDICATIONS...4 WARNINGS AND PRECAUTIONS...5 ADVERSE REACTIONS...14 DRUG INTERACTIONS...17 DOSAGE AND ADMINISTRATION...19 OVERDOSAGE...20 ACTION AND CLINICAL PHARMACOLOGY...21 STORAGE AND STABILITY...24 DOSAGE FORMS, COMPOSITION AND PACKAGING...24 PART II: SCIENTIFIC INFORMATION...25 PHARMACEUTICAL INFORMATION...25 DETAILED PHARMACOLOGY...26 TOXICOLOGY...28 REFERENCES...35 PART III: CONSUMER INFORMATION...37 Product Monograph Pr Ketorolac Tromethamine Injection USP Page 2 of 40

3 Pr KETOROLAC TROMETHAMINE INJECTION USP (Ketorolac Tromethamine) Sterile Solution 30 mg/ml Non-Steroidal Anti-Inflammatory Drug (NSAID) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Intramuscular 30 mg/ml solution Ethyl alcohol 10% (w/v), sodium chloride, sodium hydroxide and/or hydrochloric acid, water for injection. INDICATIONS AND CLINICAL USE Intramuscular injection of Ketorolac Tromethamine Injection USP is indicated for: the short-term management (not to exceed 2 days) of moderate to severe acute pain, including pain following major abdominal, orthopedic and gynecological operative procedures. The total duration of combined intramuscular and oral treatment should not exceed 5 days. For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Use of Ketorolac Tromethamine Injection USP should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Ketorolac Tromethamine Injection USP, as a NSAID, does NOT treat clinical disease or prevent its progression. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 3 of 40

4 Ketorolac Tromethamine Injection USP, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. Geriatrics (> 65 years of age): Evidence from clinical studies and post-market experience suggests that use in the geriatric population is associated with differences in safety (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics). Pediatrics (< 18 years of age): Safety and efficacy have not been established in the pediatric population. CONTRAINDICATIONS Ketorolac Tromethamine Injection USP is contraindicated in: the peri-operative setting of coronary artery bypass graft surgery (CABG). Although ketorolac tromethamine has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition labour and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants severe uncontrolled heart failure known hypersensitivity to Ketorolac Tromethamine Injection USP or to other NSAIDs, including any of the components/excipients history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/angioedema, nasal polyps, asthma). Fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reactions. The potential for cross-reactivity between different NSAIDs must be kept in mind (see WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions, Anaphylactoid Reactions). active gastric / duodenal / peptic ulcer, active GI bleeding inflammatory bowel disease. cerebrovascular bleeding or other bleeding disorders coagulation disorders, post-operative patients with high hemorrhagic risk or incomplete hemostasis in patients with suspected or confirmed cerebrovascular bleeding. immediately before any major surgery and intraoperatively when hemostasis is Product Monograph Pr Ketorolac Tromethamine Injection USP Page 4 of 40

5 critical because of the increased risk of bleeding severe liver impairment or active liver disease moderate to severe renal impairment (serum creatinine >442 mcmol/l and/or creatinine clearance <30 ml/min or 0.5 ml/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see WARNINGS AND PRECAUTIONS: Renal). known hyperkalemia (see WARNINGS AND PRECAUTIONS: Renal, Fluid and Electrolyte Balance) concurrent use with other NSAIDs due to the absence of any evidence demonstrating synergistic benefits and potential for additive side effects neuraxial (epidural or intrathecal) administration of Ketorolac Tromethamine Injection USP due to its alcohol content. concomitant use with probenecid (see DRUG INTERACTIONS). concomitant use with oxpentifylline (see DRUG INTERACTIONS). children and adolescents aged less than 18 years. WARNINGS AND PRECAUTIONS Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (see WARNINGS AND PRECAUTIONS: Cardiovascular). Ketorolac Tromethamine Injection USP is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing Ketorolac Tromethamine Injection USP to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV). Use of NSAIDs, such as Ketorolac Tromethamine Injection USP, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure. (see also WARNINGS AND PRECAUTIONS: Renal, Fluid and Electrolyte Balance) Randomized clinical trials with ketorolac tromethamine have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing Ketorolac Tromethamine Injection USP. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 5 of 40

6 Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS: Gastrointestinal) Use of NSAIDs, such as ketorolac tromethamine, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding). General The long-term use of Ketorolac Tromethamine Injection USP is not recommended as the incidence of side-effects increases with the duration of treatment (see INDICATIONS AND CLINICAL USE and DOSAGE AND ADMINISTRATION). Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Ketorolac Tromethamine Injection USP is NOT recommended for use with other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. (See DRUG INTERACTIONS: Drug-Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDs). Carcinogenesis and Mutagenesis (See PART II, TOXICOLOGY: Carcinogenicity, Mutagenicity). Cardiovascular Ketorolac Tromethamine Injection USP is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing Ketorolac Tromethamine Injection USP to patients with risk factors for cardiovascular disease, cerebrovascular disease or renal disease, such as any of the following (NOT an exhaustive list) Hypertension Dyslipidemia / Hyperlipidemia Diabetes Mellitus Congestive Heart Failure (NYHA I) Coronary Artery Disease (Atherosclerosis) Peripheral Arterial Disease Smoking Creatinine Clearance < 60 ml/min or 1 ml/sec Product Monograph Pr Ketorolac Tromethamine Injection USP Page 6 of 40

7 Use of NSAIDs, such as ketorolac tromethamine, can lead to new hypertension or can worsen pre-existing hypertension, either of which may increase the risk of cardiovascular events as described above. Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing ketorolac tromethamine should hypertension either develop or worsen with its use. Use of NSAIDs, such as ketorolac tromethamine, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renally-mediated mechanism (see WARNINGS AND PRECAUTIONS: Renal, Fluid and Electrolyte Balance). For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include the use of NSAIDs should be considered first. To minimize the potential risk for an adverse CV event, the lowest effective dose should be used for the shortest possible duration. Endocrine and Metabolism Corticosteroids: ketorolac tromethamine is NOT a substitute for corticosteroids. It does not treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids (see DRUG INTERACTIONS: Drug-Drug Interactions, Glucocorticoids). Gastrointestinal Serious GI toxicity (sometimes fatal), such as peptic/duodenal ulceration, inflammation, perforation, obstruction and gastrointestinal bleeding, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs, such as ketorolac tromethamine. Minor upper GI problems, such as dyspepsia, commonly occur at any time. Health care providers should remain alert for ulceration and bleeding in patients treated with ketorolac tromethamine, even in the absence of previous GI tract symptoms. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. The incidence of these complications increases with increasing dose. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered (see WARNINGS AND PRECAUTIONS: Special Populations, Geriatrics). Patients should be informed about the signs and/or symptoms of serious GI toxicity and instructed to discontinue using Ketorolac Tromethamine Injection USP and seek emergency medical attention if they experience any such symptoms. The utility of periodic laboratory monitoring has NOT been demonstrated, nor has it been adequately assessed. Most patients who develop a serious upper GI adverse event on NSAID therapy have no symptoms. Upper GI ulcers, gross bleeding or perforation, caused by NSAIDs appear to 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, thus increasing the likelihood of developing a serious GI event at some time during the course of therapy. Even short-term therapy has its risks. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 7 of 40

8 Caution should be taken if prescribing Ketorolac tromethamine injection USP to patients with a prior history of peptic/duodenal ulcer, disease or gastrointestinal bleeding as these individuals have a greater than 10-fold higher risk for developing a GI bleed when taking a NSAID than patients with neither of these risk factors. Other risk factors for GI ulceration and bleeding include the following: Helicobacter pylori infection, increased age, prolonged use of NSAID therapy, excess alcohol intake, smoking, poor general health status or concomitant therapy with any of the following: Anti-coagulants (e.g. warfarin) Anti-platelet agents (e.g. ASA, clopidogrel) Oral corticosteroids (e.g. prednisone) Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. citalopram, fluoxetine, paroxetine, sertraline) Close medical supervision is recommended in patients prone to gastrointestinal tract irritation. In these cases, the physician must weigh the benefits of treatment against the possible hazards. There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow the continuation of therapy with ketorolac tromethamine when and if these adverse reactions appear. Genitourinary Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with an NSAID. Some cases have become severe on continued treatment. Should urinary symptoms occur, in the absence of an alternate explanation, treatment with ketorolac tromethamine must be stopped immediately to obtain recovery. This should be done before urological investigation or treatments are carried out. Hematologic NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from hemophilia or platelet disorders should be carefully observed when ketorolac tromethamine is administered. Ketorolac tromethamine inhibits platelet function and may prolong bleeding time (see WARNINGS AND PRECAUTIONS: Hematologic, Anti-platelet Effects). It does not affect platelet count, prothrombin time (PT) or partial thromboplastin time (PTT). Anti-coagulants: Numerous studies have shown that the concomitant use of NSAIDs and anticoagulants increases the risk of bleeding. Concurrent therapy of ketorolac tromethamine with warfarin requires close monitoring of the international normalized ratio (INR). Even with therapeutic INR monitoring, increased bleeding may occur. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 8 of 40

9 Use of ketorolac tromethamine in patients who are receiving therapy that affects hemostasis should be undertaken with caution, including close monitoring. The concurrent use of ketorolac tromethamine and prophylactic, low dose heparin ( units q12h), warfarin and dextrans may also be associated with an increased risk of bleeding. In patients receiving anticoagulants, the risk of intramuscular hematoma formation from ketorolac tromethamine is increased Prothrombin time should be carefully monitored in all patients receiving oral anticoagulant therapy concomitantly with ketorolac tromethamine. Ketorolac tromethamine injection given with 2 doses of 5000 U of heparin to 11 healthy volunteers, resulted in a mean template bleeding time of 6.4 minutes ( minutes) compared to a mean of 6.0 min ( minutes) for heparin alone and 5.1 minutes ( minutes) for placebo. The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs. 99.3%) at plasma concentrations of 5-10 mcg/ml. Anti-platelet Effects: NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike acetylsalicylic acid (ASA), their effect on platelet function is quantitatively less, or of shorter duration, and is reversible. The inhibition of platelet function by ketorolac tromethamine is normalized within 24 to 48 hours after the drug is discontinued. Ketorolac tromethamine and other NSAIDs have no proven efficacy as anti-platelet agents and should NOT be used as a substitute for ASA or other anti-platelet agents for prophylaxis of cardiovascular thromboembolic diseases. Anti-platelet therapies (e.g. ASA) should NOT be discontinued. There is some evidence that use of NSAIDs with ASA can markedly attenuate the cardioprotective effects of ASA (see DRUG INTERACTIONS: Drug-Drug Interactions, Acetylsalicylic Acid (ASA) or other NSAIDs). Concomitant administration of ketorolac tromethamine with low dose ASA increases the risk of GI ulceration and associated complications. Blood dyscrasias: Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of NSAIDs are rare, but could occur with severe consequences. Anemia is sometimes seen in patients receiving NSAIDs, including ketorolac tromethamine. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including ketorolac tromethamine, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss. Hemorrhage and perioperative use of ketorolac tromethamine injection: Post-operative Product Monograph Pr Ketorolac Tromethamine Injection USP Page 9 of 40

10 hematomas and other symptoms of wound bleeding have been reported in association with the perioperative use of intramuscular ketorolac tromethamine.physicians should be aware of the potential risk of bleeding when hemostasis is critical in cases such as, but not limited to, resection of the prostate, tonsillectomy or cosmetic surgery. Ketorolac tromethamine is contraindicated in patients who have coagulation disorders. If ketorolac tromethamine is to be administered to patients who are receiving drug therapy that interferes with hemostasis, careful observation is advised. Hepatic / Biliary / Pancreatic As with other NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Meaningful elevations (greater than 3 times normal) of serum transaminases (glutamate pyruvate [SGPT or ALT] and glutamic oxaloacetic [SGOT or AST]), occurred in clinical trials in less than 1% of patients. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with this drug. Severe hepatic reactions including jaundice and cases of fatal hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes, have been reported with NSAIDs. Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop (e.g. jaundice), or if systemic manifestations occur (e.g., eosinophilia, associated with rash, etc.), ketorolac tromethamine should be discontinued. Ketorolac tromethamine is contraindicated in patients with severe liver impairment or active liver disease. If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation. Caution should be observed if ketorolac tromethamine is to be used in patients with a history of liver disease. Patients with impaired hepatic function from cirrhosis do not have any clinically important changes in ketorolac tromethamine clearance (see ACTION AND CLINICAL PHARMACOLOGY: Special Populations and Conditions). Studies in patients with active hepatitis or cholestasis have not been performed. Hypersensitivity Reactions Anaphylactoid Reactions: As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to ketorolac tromethamine. Counteractive measures must be available when administering the first dose of Ketorolac Tromethamine Injection USP. In postmarketing experience, rare cases of anaphylactic/ anaphylactoid reactions and angioedema have been reported in patients receiving ketorolac tromethamine. Ketorolac tromethamine should NOT be given to patients with the ASA-triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking ASA or other NSAIDs (see CONTRAINDICATIONS). Product Monograph Pr Ketorolac Tromethamine Injection USP Page 10 of 40

11 ASA-Intolerance: Ketorolac tromethamine should NOT be given to patients with complete or partial syndrome of ASA-intolerance (rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other NSAIDs. Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction (see CONTRAINDICATIONS). Cross-sensitivity: Patients sensitive to one NSAID may be sensitive to any of the other NSAIDs as well. Serious skin reactions: (See WARNINGS AND PRECAUTIONS: Skin) Immune (See WARNINGS AND PRECAUTIONS: Infection, Aseptic Meningitis) Infection Ketorolac tromethamine, in common with other NSAIDs, may mask signs and symptoms of an underlying infectious disease. Aseptic Meningitis: Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue diseases, etc.) seem to be pre-disposed. Therefore, in such patients, the health care provider must be vigilant to the development of this complication. Neurologic Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs, such as ketorolac tromethamine. If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness Ophthalmologic Blurred and/or diminished vision has been reported with the use of NSAIDs. If such symptoms develop, ketorolac tromethamine should be discontinued and an ophthalmologic examination performed. Ophthalmologic examination should be carried out at periodic intervals in any patient receiving ketorolac tromethamine for an extended period of time. Peri-Operative Considerations (See CONTRAINDICATIONS: Coronary Artery Bypass Graft Surgery, see WARNINGS AND PRECAUTIONS: Hematologic, Hemorrhage and perioperative use of ketorolac tromethamine injection) Psychiatric (See WARNINGS AND PRECAUTIONS: Neurologic) Product Monograph Pr Ketorolac Tromethamine Injection USP Page 11 of 40

12 Renal Long term administration of NSAIDs to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports of acute renal failure, acute interstitial nephritis, renal papillary necrosis, hematuria, low grade proteinuria and occasionally nephrotic syndrome. Renal insufficiency due to NSAID use is seen in patients with pre-renal conditions leading to reduction in renal blood flow or blood volume. Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of a NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function. Patients at greatest risk of this reaction are those with pre-existing renal insufficiency (GFR < 60 ml/min or 1 ml/s), dehydrated patients, patients on salt restricted diets, those with congestive heart failure, cirrhosis, liver dysfunction, taking angiotensin-converting enzyme inhibitors, angiotensin-ii receptor blockers, cyclosporin, diuretics, sepsis and those who are elderly. Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. Even patients at risk who demonstrate the ability to tolerate a NSAID under stable conditions may decompensate during periods of added stress (e.g. dehydration due to gastroenteritis). Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state. Caution should be used when initiating treatment with NSAIDs, such as ketorolac tromethamine, in patients with considerable dehydration. Such patients should be rehydrated prior to initiation of therapy. Caution is also recommended in patients with pre-existing kidney disease. Elevations of blood urea nitrogen (BUN) and creatinine have been reported in clinical trials with ketorolac. Ketorolac tromethamine is CONTRAINDICATED in patients with moderate to severe renal impairment. Advanced Renal Disease: (See CONTRAINDICATIONS) Fluid and Electrolyte Balance: Use of NSAIDs, such as ketorolac tromethamine, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure, edema, and exacerbation of congestive heart failure. NaCl retention, oliguria, elevations of serum urea nitrogen and creatinine have also been observed in patients treated with ketorolac tromethamine. Thus, caution should be exercised in prescribing Ketorolac Tromethamine Injection USP in patients with a history of congestive heart failure, compromised cardiac function, cardiac decompensation, hypertension, increased age or other conditions predisposing to fluid retention (see WARNINGS AND PRECAUTIONS: Cardiovascular). Use of NSAIDs, such as ketorolac tromethamine, can increase the risk of hyperkalemia, especially in patients with diabetes, mellitus, renal failure; increased age, or those receiving concomitant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-ii receptor antagonists, cyclosporin, or some diuretics Product Monograph Pr Ketorolac Tromethamine Injection USP Page 12 of 40

13 Electrolytes should be monitored periodically (see CONTRAINDICATIONS). Respiratory ASA-induced asthma is an uncommon but very important indication of ASA and NSAID sensitivity. It occurs more frequently in patients with asthma who have nasal polyps. Sexual Function/Reproduction/Fertility The use of ketorolac tromethamine, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of ketorolac tromethamine should be considered. Skin In rare cases, serious skin reactions, some of them fatal, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme have been associated with the use of some NSAIDs. Because the rate of these reactions is low, they have usually been noted during post-marketing surveillance in patients taking other medications also associated with the potential development of these serious skin reactions. Thus, causality is NOT clear. These reactions are potentially life threatening but may be reversible if the causative agent is discontinued and appropriate treatment instituted. Patients should be advised that if they experience a skin rash they should discontinue their NSAID and contact their physician for assessment and advice, including which additional therapies to discontinue. Special Populations Pregnant Women: Ketorolac tromethamine is CONTRAINDICATED for use during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and the potential to prolong parturition (see CONTRAINDICATIONS and TOXICOLOGY). Caution should be exercised in prescribing Ketorolac Tromethamine Injection USP during the first and second trimesters of pregnancy (see TOXICOLOGY). Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryo-foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. Ketorolac tromethamine is not recommended in labour and delivery because, through their prostaglandin synthesis inhibitory effect, they may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage (see CONTRAINDICATIONS). Product Monograph Pr Ketorolac Tromethamine Injection USP Page 13 of 40

14 Nursing Women: (see CONTRAINDICATIONS) Pediatrics: (see CONTRAINDICATIONS) Geriatrics: Patients older than 65 years (referred to in this document as older or elderly) and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal injury including ulceration and bleeding. For such patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. Post-marketing experience with ketorolac tromethamine suggests that there may be a greater risk of gastrointestinal ulcerations, bleeding, and perforation in the elderly, and most spontaneous reports of fatal gastrointestinal events are in this population. This is particularly true in elderly patients who receive an average daily dose greater than 60 mg/day of ketorolac tromethamine. Because ketorolac is cleared somewhat more slowly by the elderly (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics), extra caution and the lowest effective dose should be used (see DOSAGE AND ADMINISTRATION). Monitoring and Laboratory Tests The following testing or monitoring is recommended for various populations of patients taking ketorolac tromethamine. This is not an exhaustive list. Renal function parameters such as serum creatinine and serum urea (in case of coprescription of anti-hypertensives, methotrexate, cyclosporine, adrenergic blockers and in susceptible patients regarding the renal effects of NSAIDS e.g. impaired renal function or dehydration). See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS: Renal, and DRUG INTERACTIONS. Blood pressure (in case of anti-hypertensives co-prescription, and in susceptible patients with fluid retention) INR/effects of anticoagulants (Co-prescription of oral anticoagulants). See WARNINGS AND PRECAUTIONS: Hematologic. Lithium plasma concentrations (in case of lithium co-prescription) ADVERSE REACTIONS Adverse Drug Reaction Overview The most common adverse reactions encountered with non-steroidal anti-inflammatory drugs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 14 of 40

15 Adverse drug reaction information from clinical trials is useful for identifying drugrelated adverse events and for approximating rates. Ketorolac Tromethamine Injection The adverse reactions listed below were reported in ketorolac tromethamine injection clinical efficacy trials. In these trial patients (N=660) received either single 30 mg doses (N=151) or multiple 30 mg doses (N=509) over a time period of 5 days or less for pain resulting from surgery. These reactions may or may not be drug related. Table 1: Most Common Clinical Trial Adverse Drug Reactions (10-13%, 4-9% and 2-3%) Body System Incidence Adverse Reaction Nervous System 10-13% Somnolence 4-9% Headache 2-3% Sweating, dizziness Digestive System 10-13% Nausea 4-9% Vomiting Injection Site 4-9% Injection site pain Cardiovascular System 2-3% Vasodilation Less Common Clinical Trial Adverse Drug Reactions ( 1%) Nervous system: Insomnia, increased dry mouth, abnormal dreams, anxiety, depression, paraesthesia, nervousness, paranoid reaction, speech disorder, euphoria, libido increased, excessive thirst, inability to concentrate, stimulation Digestive System: Flatulence, anorexia, constipation, diarrhea, dyspepsia, gastrointestinal fullness, gastrointestinal hemorrhage, gastrointestinal pain, melena, sore throat, liver function abnormalities, rectal bleeding, stomatitis Cardiovascular System: Hypertension, chest pain, tachycardia, hemorrhage, palpitation, pulmonary embolus, syncope, ventricular tachycardia, pallor, flushing Injection Site: Injection site reaction Body as a Whole: Asthenia, fever, back pain, chills, pain, neck pain Special Senses: Taste perversion, tinnitus, blurred vision, diplopia, retinal hemorrhage Musculo-skeletal System: Myalgia, twitching Product Monograph Pr Ketorolac Tromethamine Injection USP Page 15 of 40

16 Respiratory System: Asthma, cough increased, dyspnea, epistaxis, hiccup, rhinitis Skin and Appendages: Pruritus, rash, subcutaneous hematoma, skin disorder Urogenital System: Dysuria, urinary retention, oliguria, increased urinary frequency, vaginitis Metabolic/Nutritional Disorders: Edema, hypokalemia, hypovolemia Hematologic and Lymphatic System: Anemia, coagulation disorder, purpura Abnormal Hematologic and Clinical Chemistry Findings Elevations of blood urea nitrogen (BUN) and creatinine have been reported in clinical trials with ketorolac. Post-Market Adverse Drug Reactions Additional reports of adverse events temporally associated with ketorolac tromethamine during worldwide post-marketing experience are included below. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or clearly establish a causal relationship to ketorolac tromethamine exposure. The following post-marketing adverse experiences have been reported for patients who have received ketorolac tromethamine (tablets and injection): Renal Events: Acute renal failure, flank pain with or without hematuria and/or azotemia, nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome, urinary retention Hypersensitivity Reactions: Bronchospasm, laryngeal edema, asthma, hypotension, flushing, rash, anaphylaxis, angioedema and anaphylactoid reactions. Such reactions have occurred in patients with no prior history of hypersensitivity Gastrointestinal Events: Gastrointestinal hemorrhage, peptic ulceration, gastrointestinal perforation, pancreatitis, melena, esophagitis, hematemesis Hematologic Events: Postoperative wound hemorrhage, rarely requiring blood transfusion (see WARNINGS AND PRECAUTIONS), thrombocytopenia, epistaxis, leukopenia, hematomata, increased bleeding time Central Nervous System: Convulsions, abnormal dreams, hallucinations, hyperkinesia, hearing loss, aseptic meningitis, extrapyramidal symptoms, psychotic reactions Hepatic Events: Hepatitis, liver failure, cholestatic jaundice Cardiovascular: Pulmonary edema, hypotension, flushing, bradycardia Reproductive, female: Infertility Product Monograph Pr Ketorolac Tromethamine Injection USP Page 16 of 40

17 Dermatology: Lyell s syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticaria Body as Whole: Infection Urogenital: Interstitial nephritis, nephrotic syndrome, raised serum urea and creatinine DRUG INTERACTIONS Drug-Drug Interactions Acetylsalicylic acid (ASA) or other NSAIDs: The use of ketorolac tromethamine in addition to most NSAIDs, including over the counter ones (such as Ibuprofen) for analgesic and/or antiinflammatory effects is usually contraindicated because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. The exception is the use of low dose ASA for cardiovascular protection, when another NSAID is being used for its analgesic/anti-inflammatory effect, keeping in mind that combination NSAID therapy is associated with additive adverse reactions. Some NSAIDs (e.g. ibuprofen) may interfere with the anti-platelet effects of low dose ASA, possibly by competing with ASA for access to the active site of cyclooxygenase-1. In vitro studies indicated that, at therapeutic concentrations of salicylates (300 mcg/ml), the binding of ketorolac tromethamine was reduced from approximately 99.2% to 97.5% representing a potential two-fold increase in unbound ketorolac tromethamine plasma levels. Antacids: There is no definitive evidence that the concomitant administration of histamine H2- receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow the continuation of ketorolac tromethamine therapy when and if these adverse reactions appear. Anti-coagulants: (See WARNINGS AND PRECAUTIONS: Hematologic, Anticoagulants). Anti-hypertensives: NSAIDs may diminish the anti-hypertensive effects of angiotensin converting enzyme (ACE) inhibitors. Combinations of ACE inhibitors, angiotensin-ii antagonists, or diuretics with NSAIDs might have an increased risk for acute renal failure and hyperkalemia. Blood pressure and renal function (including electrolytes) should be monitored more closely in this situation, as occasionally there can be a substantial increase in blood pressure. Anti-platelet Agents (including ASA): There is an increased risk of bleeding, via inhibition of platelet function, when anti-platelet agents are combined with NSAIDs, such as ketorolac tromethamine (see WARNINGS AND PRECAUTIONS: Hematologic, Anti-platelet Effects). Product Monograph Pr Ketorolac Tromethamine Injection USP Page 17 of 40

18 Cyclosporin: (See WARNINGS AND PRECAUTIONS: Renal). Digoxin: Concomitant administration of an NSAID with digoxin can result in an increase in digoxin concentrations which may result in digitalis toxicity. Increased monitoring and dosage adjustments of digitalis glycosides may be necessary during and following concurrent NSAID therapy. Ketorolac tromethamine does not alter digoxin protein binding. Diuretics: Clinical studies as well as post-marketing observations have shown that NSAIDs can reduce the effect of diuretics. Ketorolac tromethamine reduces the diuretic response to furosemide by approximately 20% in normovolemic subjects, so particular care should be taken in patients with cardiac decompensation. Glucocorticoids: Some studies have shown that the concomitant use of NSAIDs and oral glucocorticoids increases the risk of GI adverse events such as ulceration and bleeding. This is especially the case in older (>65 years of age) individuals. Lithium: Monitoring of plasma lithium concentrations is advised when stopping or starting a NSAID, as increased lithium concentrations can occur. Some NSAIDs have been reported to inhibit renal lithium clearance, leading to an increase in plasma lithium concentrations and potential lithium toxicity. The effect of ketorolac tromethamine on lithium plasma levels has not been studied. Cases of increased lithium plasma concentrations during ketorolac tromethamine therapy have been reported. Methotrexate: Caution is advised in the concomitant administration of methotrexate and NSAIDs, as this has been reported to reduce the clearance of methotrexate, thus enhancing its toxicity. In case combination treatment with methotrexate and NSAIDs is necessary, blood cell count and the renal function should be monitored. Concomitant administration of NSAIDs with a potentially myelotoxic drug, such as methotrexate, appears to be a predisposing factor to the onset of a cytopenia. Oxpentifylline: When ketorolac tromethamine is administered concurrently with oxpentifylline, there is an increased tendency to bleeding. The concomitant use of ketorolac tromethamine and oxpentifylline is contraindicated. Probenecid: Concomitant administration of ketorolac tromethamine and probenecid results in the decreased clearance and volume of distribution of ketorolac and a significant increase in ketorolac plasma levels (approximately three-fold increase) and terminal half-life (approximately two-fold increase). The concomitant use of ketorolac tromethamine and probenecid is contraindicated. Selective Serotonin Reuptake Inhibitors (SSRIs): Concomitant administration of NSAIDs and SSRIs may increase the risk of gastrointestinal ulceration and bleeding (see WARNINGS AND PRECAUTIONS: Gastrointestinal). Product Monograph Pr Ketorolac Tromethamine Injection USP Page 18 of 40

19 Drug-Herb Interactions Interactions with herbal products have not been established. Drug-Laboratory Interactions Interactions with laboratory tests have not been established. Drug-Lifestyle Interactions Potential Effects on Driving and Using Machinery: Some patients may experience drowsiness dizziness vertigo insomnia or depression with the use of ketorolac tromethamine. Therefore, patients should exercise caution in carrying out potentially hazardous activities that require alertness. DOSAGE AND ADMINISTRATION Dosing Considerations Use of ketorolac tromethamine should be limited to the lowest effective dose for the shortest possible duration of treatment (see INDICATIONS AND CLINICAL USE). Recommended Dose and Dosage Adjustment Adults (>18 years of age): Dosage should be adjusted according to the severity of the pain and the response of the patient. Ketorolac Tromethamine Injection, USP (Intramuscular): The recommended usual initial dose is mg, according to pain severity. Subsequent dosing may be 10 mg to 30 mg every 4-6 hours as needed to control pain. The lowest effective dose should be administered. The administration of Ketorolac Tromethamine Injection USP should be limited to short-term therapy (not over 2 days). The total daily dose should not exceed 120 mg because the risk of toxicity appears to increase with longer use at recommended doses (see WARNINGS AND PRECAUTIONS). The administration of continuous multiple daily doses of ketorolac tromethamine has not been extensively studied. There has been limited experience with intramuscular dosing for more than 3 days since the vast majority of patients have transferred to oral medication or no longer required analgesic therapy after this time. Conversion from Parenteral to Oral Therapy When ketorolac tromethamine tablets are used as a follow-on therapy to parenteral ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac Tromethamine Injection USP should be replaced by an oral analgesic as soon as feasible. The total duration of combined intramuscular and oral treatment should not exceed 5 days. Renal Impairment Product Monograph Pr Ketorolac Tromethamine Injection USP Page 19 of 40

20 Ketorolac Tromethamine Injection USP is contraindicated in patients with moderate to severe renal impairment (serum creatinine >442 mcmol/l). Ketorolac tromethamine should be used with caution in patients with lesser renal impairment (serum creatinine mcmol/l). Such patients should receive a reduced dose of Ketorolac Tromethamine Injection USP, and their renal status should be closely monitored. It is recommended that the daily dose be reduced by half; a total daily dose of 60 mg should not be exceeded. Dialysis does not significantly clear ketorolac from blood stream. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS: Renal and ACTION AND CLINICAL PHARMACOLOGY: Special Populations and Conditions, Renal Insufficiency. Hepatic Impairment Ketorolac Tromethamine Injection USP is contraindicated in patients with severe liver impairment or active liver disease. Caution should be observed in giving Ketorolac Tromethamine Injection USP to patient with mild to moderate hepatic insufficiency. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic and ACTION AND CLINICAL PHARMACOLOGY: Special Populations and Conditions, Hepatic Insufficiency. Elderly, Frail or Debilitated Patients These patients are at increased risk of the serious consequences of adverse reactions. Parenteral: The lower end of the dosage range is recommended. The initial dose should be 10 mg. The total daily dose of Ketorolac Tromethamine Injection USP in the elderly should not exceed 60 mg. Missed Dose The missed dose should be taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of ketorolac tromethamine should not be taken at the same time. Administration Parenteral drug products should be inspected visually for particulate material and discoloration prior to use. OVERDOSAGE Signs and Symptoms: Overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis, gastrointestinal bleeding, and renal dysfunction which have generally resolved after discontinuation of dosing. Metabolic acidosis has been reported following intentional overdosage. Although rare, hypertension, acute renal failure, respiratory depression, coma and death have been reported after significant overdose of NSAIDs. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 20 of 40

21 In a gastroscopic study of healthy subjects, daily doses of 360 mg given over an 8-hour interval for each of five consecutive days (3 times the highest recommended dose) caused pain and peptic ulcers which resolved after discontinuation of dosing. Treatment Patients should be managed by symptomatic and supportive care following overdose. There are no specific antidotes. Dialysis does not significantly clear ketorolac from the bloodstream. For management of a suspected drug overdose, contact your regional Poison Control Centre. ACTION AND CLINICAL PHARMACOLOGY Pain relief is comparable following the administration of ketorolac by intramuscular or oral routes. The peak analgesic effect occurs 2-3 hours post-dosing with no evidence of a statistically significant difference over the recommended dosage range. The greatest difference between large and small doses of ketorolac tromethamine administered by either route is in the duration of analgesia. Mechanism of Action Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity mediated by peripheral effects. The mechanism of action of ketorolac, like that of other NSAIDS, is not completely understood, but is believed to be related to prostaglandin synthetase inhibition. Pharmacodynamics (See DETAILED PHARMACOLOGY) Pharmacokinetics The pharmacokinetics are linear following single and multiple dosing. Steady state plasma levels are attained after one day of Q.I.D. dosing. Following intramuscular administration, peak plasma concentrations of 2.2 to 3.0 mcg/ml occur at an average of 50 minutes after a single 30 mg dose. The terminal plasma half-life ranges between 3.5 and 9.2 hours in young adults and between 4.7 and 8.6 hours in elderly subjects (mean age = 72 years). In renally impaired patients, there is a reduction in clearance and an increase in the terminal halflife of ketorolac tromethamine (see table 2 below). The parenteral administration of ketorolac tromethamine has not been demonstrated to affect the hemodynamics of anesthetized patients. Product Monograph Pr Ketorolac Tromethamine Injection USP Page 21 of 40

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