Ketorolac Trometamol Darya-Varia

Ketorolac Trometamol Darya-Varia

ketorolac

Manufacturer:

Darya-Varia

Distributor:

Royal Ruby
Full Prescribing Info
Contents
Ketorolac trometamol.
Description
Each ampoule (1 mL) contains: Ketorolac trometamol 30 mg.
Action
Pharmacology: Pharmacodynamics: Ketorolac trometamol is a non-steroidal anti-inflammatory agent (NSAID) which exerts its actions in cyclooxygenase pathway by inhibiting prostaglandin biosynthesis. It exhibits strong analgesic activity both peripherally and centrally. It also has anti-inflammatory and antipyretic effects.
Pharmacokinetics: Ketorolac trometamol is rapidly and completely absorbed following intramuscular (IM) administration with a mean peak plasma concentration of 2.2 mcg/mL occurring an average of 50 minutes after a single 30 mg dose. The terminal plasma half-life is 5.3 hours in young adults and 7 hours in elderly subjects (mean age 72).
Indications/Uses
Ketorolac trometamol is indicated for short term management of moderately severe, acute pain following surgical procedures. The total duration of ketorolac used should not exceed five days.
Dosage/Direction for Use
Ketorolac trometamol ampoules are for administration by IM or bolus IV injection. The total duration of ketorolac used should not exceed 5 days. Before ketorolac administration, the hypovolemia condition should be corrected. Intravenous injection administered minimum within 15 seconds. The time to onset of analgesic effect following both IV and IM administration is similar and approximately 30 minutes with maximum analgesia occurring within 1-2 hours after. The duration of analgesic effect is 4-6 hours. If pain occurs, dose or frequent administration of ketorolac should not be increased.
Should be considered to add minimum dose of opiate (if necessary), unless if there are any contraindications.
Recommended initial dose is 10 mg followed by 10-30mg every 4-6 hours as required. The lowest effective dose should be given. A total daily dose of 90 mg for non elderly and 60 mg for the elderly, renally impaired patients and patients <50 kg should not be exceeded.
The maximum duration of treatment should not exceed 2 days. The lowest effective dose should be used for the shortest possible time in all patient population. For patients receiving ketorolac ampoules, the total combined daily dose should not exceed 90 mg (60 mg for the elderly, renally impaired patients and patients <50 kg).
Special dosage instructions: Elderly: for patients >65 years, the lower end of the dosage range is recommended. A total daily dose of 60 mg should not be exceeded.
Children: Safety and efficacy in children have not been established. Therefore, ketorolac is contraindicated for use in children <16 years.
Renal impairment: Since ketorolac trometamol and its metabolites are excreted primarily by the kidney, ketorolac is contraindicated in moderate to severe renal impairment (serum creatinine >160 micromole/L); patients with mild renal impairment should receive a reduced dose (not exceeding 60 mg/day IV or IM), and their status should be closely monitored.
Contraindications
History of hypersensitivity to ketorolac trometamol or aspirin or other NSAIDs.
Patients with active peptic ulcer, recently had gastrointestinal hemorrhage or perforation and history of peptic ulcer disease or gastrointestinal bleeding.
Severe renal dysfunction or those with high risk of renal failure.
Ketorolac is not recommended during pregnancy, labour or delivery, because its effects on fetal circulation and uterine contraction could increase risk of uterine bleeding.
Lactation (effects of prostaglandin inhibition in neonatus).
Haemostasis disorder.
Suspected or confirmed cerebrovascular disease, haemorrhage diatheses or incomplete haemostasis, and those with high risk of bleeding.
Concurrent treatment with other NSAIDs or probenecid.
Neuraxial (epidural or intrathecal) administration.
Children <16 years.
Concurrent treatment with oxpentifylline, probenecid or lithium salt.
A history of asthma.
The complete or partial syndrome of nasal polyps, angioedema or bronchospasm.
Special Precautions
As with non-steroidal anti-inflammatory analgesic agents, ketorolac can cause gastrointestinal irritation, ulcers, perforation or bleeding with or without previous symptoms and should be given under close supervision to patients with a history of gastrointestinal tract disease: Patients who have coagulation disorders (hemophilic) or are receiving anticoagulant drug therapy should be carefully observed when ketorolac is administered.
Hematological effects: ketorolac inhibits platelet aggregation and may prolong bleeding time; ketorolac is not recommended for use as pre-operative medication, and should be considered to patients with haemostatic problem.
Using ketorolac in patients with heart disease, acute renal failure, hypertension or other similar condition that related to fluid retention should be with caution.
Hepatic effects: ketorolac should be used with caution in patients with impaired hepatic function or history of liver disease. Ketorolac can elevate the liver enzyme, and in patients with liver disease, severe hepatic reaction can occur. Ketorolac should be discontinued if liver function test is abnormal after administered ketorolac.
Fluid retention and edema: Fluid retention and edema have been reported with the use of ketorolac, therefore it should be used with caution in patients with cardiac decompensation, hypertension or similar conditions.
Use in Children: Ketorolac is not recommended in children <16 years of age (safety and efficacy still not clear).
Side Effects
Incidence of side effects increase in conjunction with increased doses of ketorolac. Severe complications due to therapy with ketorolac e.g.: ulcers, GI bleeding and perforation, postoperative haemorrhage, acute renal failure, anaphylactic and anaphylactoid reactions, and liver failure, must be eyed with caution. The NSAIDs related complications could be severe, especially when ketorolac was not used according to the proper directions. The adverse reactions listed as follows were reported to be probably related to ketorolac in clinical trials: Incidence >1%: The following incidences in the parentheses were reported occurring in 3 patients: Body as a whole: Edema (4%).
Cardiovascular: Hypertension.
Dermatologic: Pruritus, rash.
Gastrointestinal: Nausea (12%), dyspepsia (12%), gastrointestinal pain (13%), diarrhea (7%), constipation, flatulence, gastrointestinal fullness, vomiting, stomatitis.
Hematologic and lymphatic: Purpura.
Nervous system: Cephalgia (17%), drowsiness (6%), dizziness (7%), sweating.
Pain in the injection site was reported by 2 of patients in studies using multiple doses.
Incidence ≤1%: Body as a whole: weight gain, fever, infection, asthenia.
Cardiovascular: Palpitation, paleness, syncope.
Dermatologic: Urticaria.
Gastrointestinal: Gastritis, rectal bleeding, belching, anorexia, increased appetite.
Haematologic and Lymphatic: Epistaxis, anaemia, eosinophilia.
Nervous system: Tremor, abnormal dreams, hallucination, euphoria, extrapyramidal symptoms, vertigo, paresthesia, depression, insomnia, nervousness, excessive thirst, mouth dryness, abnormal thinking, inability to concentrate, hyperkinesis, stupor.
Respiratory: Dyspnea, lung edema, rhinitis, cough.
Sensory Organ: Abnormal taste, abnormal vision, blurred vision, tinnitus, deafness.
Urogenital: Hematuria, proteinuria, oliguria, urine retention, polyuria, increased micturition.
Pain in the injection site was reported by 2 of patients in studies using multiple doses.
Drug Interactions
Even though there is no significant interaction observed between ketorolac and warfarin/heparin, administrating ketorolac to patients receiving concomitant administration of anticoagulant should be done with caution and intense observation from the physician.
Administrating ketorolac in combination with other NSAIDs is generally not recommended, since it may enhance side effect. (See table.)

Click on icon to see table/diagram/image

No interaction were reported between ketorolac and anti-infection compounds, antiemetics, laxatives, sedatives, anxiolytics, corticosteroids, bronchodilators or hormones.
There is no evidence (both in animal and human) supporting the hypotheses that ketorolac may induce or inhibit liver enzymes responsible for its metabolism and other drugs as well.
Caution For Usage
Special precautions: Incompatibility: Ketorolac ampoules should not be mixed in a small volume (eg. in a syringe) with morphine sulfate, pethidine HCl, promethazine or hydroxyzine HCl as precipitation of ketorolac tromethamine will occur. Ketorolac ampoules are compatible with normal saline, dextrose 5%, ringer's solution, lactate ringer solution or plasmalyte solution.
Compatibility with other drugs is unknown.
Storage
Store at temperature below 30°C.
ATC Classification
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Inj (amp) 30 mg/mL x 1 mL x 5's.
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