Dosage and administration:
Dosing Considerations: Use of TORADOL should be limited to the lowest effective dose for the shortest possible duration of treatment (see INDICATIONS AND CLINICAL USE). In no case is the duration of TORADOL treatment to exceed 7 days.
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.
Oral: The usual oral dose of TORADOL (ketorolac tromethamine) is 10 mg every 4 to 6 hours for pain as required. Doses exceeding 40 mg per day are not recommended. The maximum duration of treatment with the oral formulation is 5 days for post-surgical patients and 7 days for patients with musculoskeletal pain. TORADOL is not indicated for chronic use.
Conversion from Parenteral to Oral Therapy: When TORADOL 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 IM 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: TORADOL is contraindicated in patients with moderate to severe renal impairment (serum creatinine >442 μmol/L). TORADOL should be used with caution in patients with lesser renal impairment (serum creatinine 170 – 442 μmol/L). Such patients should receive a reduced dose o TORADOL, 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 bloodstream. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS:
Renal and ACTION AND CLINICAL PHARMACOLOGY: Special Populations and Conditions, Renal Insufficiency.
Hepatic Impairment: TORADOL is contraindicated in patients with severe liver impairment or active liver disease. Caution should be observed in giving TORADOL to patient with mild to moderate hepatic insufficiency. See CONTRAINDICATIONS.
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. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
TORADOL TABLETS
SHORT-TERM PATIENT STUDIES
The incidence of adverse reactions in 371 patients receiving multiple 10 mg doses of TORADOL (ketorolac tromethamine) for pain resulting from surgery or dental extraction during the postoperative period (less than 2 weeks) is listed below. These reactions may or may not be drug related
Nervous System: abnormal dreams, anxiety, dry mouth, hyperkinesia, paresthesia, increased sweating, euphoria, hallucinations
Digestive System: anorexia, flatulence, vomiting, stomatitis, gastritis, gastrointestinal disorder, sore throat
Body as a Whole: asthenia, pain, back pain
Cardiovascular System: increased cough, rhinitis, dry nose
Musculoskeletal System: myalgia, arthralgia
Skin and Appendages: rash, urticarial
Special Senses: vision, ear pain
Urogenital System: dysuria
LONG-TERM PATIENT STUDY
The adverse reactions listed below were reported to be probably related to study drug in 553 patients receiving long-term oral therapy (approximately 1 year) with TORADOL.
Digestive System: Eructation, stomatitis, vomiting, anorexia, duodenal ulcer, gastritis, gastrointestinal haemorrhage, increased appetite, melena, mouth ulceration, rectal bleeding, sore mouth.
Nervous System: Abnormal dreams, anxiety, depression, dry mouth, insomnia, nervousness, paresthesia
Special Senses: Tinnitus, taste perversion, abnormal vision, blurred vision, deafness, lacrimation disorder
Metabolic/Nutritional Disorder: Weight gain, alkaline phosphatase increase, BUN increased, excessive thirst, generalized edema, hyperuricemia
Skin & Appendages: Pruritus, rash, burning sensation skin
Body as a Whole: Asthenia, pain, back pain, face edema, hernia
Musculo-skeletal System: Arthralgia, myalgia, joint disorder
Cardiovascular System: Chest pain, chest pain substernal, migraine
Respiratory System: Dyspnea, asthma, epistaxis
Urogenital System: Haematuria, increased urinary frequency, oliguria, polyuria
Haematic & Lymphatic: Anemia, purpura
Abnormal Haematologic 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 TORADOL 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 TORADOL exposure. The following post-marketing adverse experiences have been reported for patients who have received either formulation of TORADOL:
Renal Events: acute renal failure, flank pain with or without haematuria 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 haemorrhage, rarely requiring blood transfusion (see 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.
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.
Contraindications:
TORADOL is contraindicated in:
-
- the peri-operative setting of coronary artery bypass graft surgery (CABG). Although TORADOL 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 peri-operative setting of coronary artery bypass graft surgery (CABG). Although TORADOL 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
-
- 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 haemorrhage
-
- women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants
-
- severe uncontrolled heart failure
-
- known hypersensitivity to TORADOL or to other NSAIDs, including any of the
components/excipients
- known hypersensitivity to TORADOL or to other NSAIDs, including any of the
-
- 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 reaction. The potential for cross-reactivity between different NSAIDs must be kept in mind (see WARNINGS AND PRECAUTIONS: Hypersensitiv ity Reactions, Anaphylactoid Reactions)
- history of asthma, urticaria, or allergic-type reactions after taking ASA or other
-
- active gastric / duodenal / peptic ulcer, active GI bleeding
-
- inflammatory bowel disease
-
- cerebrovascular bleeding or other bleeding disorders
-
- coagulation disorders, post-operative patients with high haemorrhagic risk or
incomplete haemostasis in patients with suspected or confirmed cerebrovascular
bleeding.
- coagulation disorders, post-operative patients with high haemorrhagic risk or
-
- immediately before any major surgery and intraoperatively when haemostasis is critical because of the increased risk of bleeding
-
- severe liver impairment or active liver disease
-
- moderate to severe renal impairment (serum creatinine >442 μmol/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)
- known hyperkalemia (see WARNINGS AND PRECAUTIONS: Renal, Fluid and
-
- concurrent use with other NSAIDs due to the absence of any evidence demonstrating synergistic benefits and potential for additive side effects
-
- concomitant use with probenecid (see DRUG INTERACTIONS)
-
- concomitant use with oxpentifylline (see DRUG INTERACTIONS)
- children and adolescents aged less than 18 years
Special Populations
Pregnant Women:Â TORADOL 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 TORADOL 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.
TORADOL 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).
Nursing Women:Â (see CONTRAINDICATIONS)
Pediatrics:Â (see CONTRAINDICATIONS)
Geriatrics:Â 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 TORADOL 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 TORADOL. Because ketorolac is cleared somewhat more slowly by the elderly (see PHARMACOKINETICS), extra caution and the lowest effective dose should be used (see DOSAGE ANDADMINISTRATION).
Monitoring and Laboratory Tests: The following testing or monitoring is recommended for various populations of patients taking TORADOL. This is not an exhaustive list.
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- 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.
- Renal function parameters such as serum creatinine and serum urea (in case of
-
- 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.
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- INR/effects of anticoagulants (Co-prescription of oral anticoagulants). See
WARNINGS AND PRECAUTIONS: Hematologic.
- INR/effects of anticoagulants (Co-prescription of oral anticoagulants). See
- Lithium plasma concentrations (in case of lithium co-prescription)
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