Ketorolac


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Postoperative pain Moderate to severe: As a continuation therapy from parenteral (IM/IV) dosing: Initially, 20 mg followed by 10 mg 4-6 hourly as needed. <50 kg: Initially, 10 mg followed by 10 mg 4-6 hourly as needed. Max: 40 mg daily. Max duration: 5 days (combined oral and parenteral). IV/IM Postoperative pain Moderate to severe: Initially, 10 mg followed by 10-30 mg 4-6 hourly as needed, may be given as often as 2 hourly in the initial postoperative period if necessary. Max: 90 mg daily. <50 kg: Reduce dose. Max: 60 mg daily. All doses to be given by IM or IV over 15 seconds. Max duration: 2 days. Ophthalmic Seasonal allergic conjunctivitis As 0.5% solution: Instill 1 drop into the affected eye(s) 4 times daily. Prophylaxis and reduction of postoperative ocular inflammation As 0.5% solution: Instill 1 drop into the affected eye(s) 4 times daily starting 24 hours after ocular surgery, continue for 2 weeks of the postoperative period. As 0.45% solution: Instill 1 drop into the affected eye(s) bid starting 24 hours prior to ocular surgery until the day of surgery, continue for 2 weeks of postoperative period. As 0.4% solution: Instill 1 drop into the affected eye(s) 4 times daily as necessary for up to 4 days after surgery. Nasal Moderate to severe pain 1 spray (15.75 mg) in each nostril 6-8 hourly. Max: 126 mg daily. <50 kg: 1 spray (15.75 mg) in only 1 nostril 6-8 hourly. Max: 63 mg daily.
Dosage Details
Nasal
Moderate to severe pain
Adult: 1 spray (15.75 mg) in each nostril every 6-8 hours. Max: 126 mg daily. <50 kg: 1 spray (15.75 mg) in only 1 nostril every 6-8 hours. Max: 63 mg daily.
Elderly: 1 spray (15.75 mg) in only 1 nostril every 6-8 hours. Max: 63 mg daily.

Ophthalmic
Prophylaxis and reduction of postoperative ocular inflammation
Adult: As 0.5% solution: Instill 1 drop into the affected eye(s) 4 times daily starting 24 hours after ocular surgery, continue for 2 weeks of the postoperative period. As 0.45% solution: Instill 1 drop into the affected eye(s) bid starting 24 hours prior to ocular surgery until the day of surgery, continue for 2 weeks of postoperative period. As 0.4% solution: Instill 1 drop into the affected eye(s) 4 times daily as necessary for up to 4 days after surgery.

Ophthalmic
Seasonal allergic conjunctivitis
Adult: As 0.5% solution: Instill 1 drop into the affected eye(s) 4 times daily.

Oral
Postoperative pain
Adult: Moderate to severe: As a continuation therapy from parenteral (IM/IV) dosing: Initially, 20 mg followed by 10 mg every 4-6 hours as needed. <50 kg: Initially, 10 mg followed by 10 mg every 4-6 hours as needed. Max: 40 mg daily. Max duration: 5 days (combined oral and parenteral).
Elderly: Moderate to severe: As a continuation therapy from parenteral (IM/IV) dosing: Initially, 10 mg followed by 10 mg every 4-6 hours as needed. Max: 40 mg daily.

Parenteral
Postoperative pain
Adult: Moderate to severe: Initially, 10 mg followed by 10-30 mg every 4-6 hours as needed, may be given as often as every 2 hours in the initial postoperative period if necessary. Max: 90 mg daily. <50 kg: Reduce dose. Max: 60 mg daily. All doses to be given by IM or IV over 15 seconds. Max duration: 2 days. Convert to oral treatment once possible.
Elderly: Initiate at lowest effective dose and for the shortest possible duration. Max: 60 mg daily.
Renal Impairment
Oral
Postoperative pain: Mild: As a continuation therapy from parenteral (IM/IV) dosing: Initially, 10 mg followed by 10 mg every 4-6 hours as needed. Max: 40 mg daily. Moderate to severe: Contraindicated.

Parenteral
Postoperative pain: Mild: Reduce dose. Max: 60 mg daily. Moderate to severe: Contraindicated.

Nasal
Moderate to severe pain: 1 spray (15.75 mg) in only 1 nostril every 6-8 hours. Max: 63 mg daily.
Hepatic Impairment
Parenteral
Postoperative pain: Severe: Contraindicated.
Incompatibility
Syringe: Morphine, meperidine, promethazine, hydroxyzine.
Contraindications
Hypersensitivity to ketorolac, aspirin or other NSAIDs. History of bronchospasm, asthma, rhinitis, urticaria or other allergic-type reactions associated with aspirin or NSAID therapy. active or history of peptic ulceration, gastrointestinal bleeding or perforation, confirmed or suspected cerebrovascular bleeding, haemorrhagic diathesis, incomplete haemostasis, high risk of bleeding; severe heart failure, risk of renal failure due to volume depletion or dehydration, treatment of pain in the setting of CABG, or prophylactic analgesic prior to any major surgery, labour and delivery. Moderate to severe renal and severe hepatic impairment. Pregnancy (3rd trimester). Concomitant use with aspirin or NSAIDs, probenecid, pentoxifylline.
Special Precautions
Patients with inflammatory disease (e.g. ulcerative colitis, Crohn’s disease), coagulation disorders, increased risk for gastrointestinal bleeding (e.g. smoking, use of alcohol) or CV thrombotic events (e.g. MI, stroke), hypertension, oedema, diabetes mellitus, SLE, asthma, hypovolaemia, low body weight (<50 kg). Debilitated patients. Mild renal and hepatic impairment. Elderly. Pregnancy (1st and 2nd trimester) and lactation. Concomitant use of corticosteroids, SSRIs, antiplatelets, anticoagulants, diuretics, or ACE inhibitors. Ophthalmic: Patients with complicated ocular surgery or repeat ocular surgery (within a short timeframe), corneal epithelial defects, corneal denervation, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis.
Adverse Reactions
Significant: Renal papillary necrosis, acute renal failure, interstitial nephritis, nephrotic syndrome, hypertension, fluid retention, hyperkalaemia. Rarely, blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia). Ophthalmic: Keratitis, corneal thinning, erosion, ulceration or perforation.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Blurred vision, increased intraocular pressure, conjunctival hyperaemia, lacrimation, corneal infiltrates, eye or eyelid oedema, eye irritation, pain, inflammation or infection.
Gastrointestinal disorders: Abdominal pain, dyspepsia, nausea, flatulence, constipation, diarrhoea, heartburn, vomiting, stomatitis.
Injury, poisoning and procedural complications: Injection site pain.
Investigations: Elevated liver enzymes.
Nervous system disorders: Headache, drowsiness, dizziness.
Respiratory, thoracic and mediastinal disorders: Nasal discomfort, rhinalgia.
Skin and subcutaneous tissue disorders: Rash, pruritus, purpura.
Potentially Fatal: Gastrointestinal bleeding, ulceration or perforation, CV thrombotic events (e.g. myocardial infarction, stroke), bronchospasm, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Rarely, severe hepatic reactions (e.g. jaundice, fulminant hepatitis, hepatic necrosis, hepatic failure).
IM/IV/Ophth/Parenteral/PO: C; Nasal: C (prior to 30 weeks gestation), D (starting at 30 weeks gestation)
Patient Counseling Information
This drug may cause drowsiness, dizziness and blurred vision, if affected do not drive or operate machinery. Oral therapy is only indicated for use as continuation following parenteral treatment. Ophthalmic: Remove contact lenses prior to instillation and may reinsert after at least 15 minutes.
MonitoringParameters
Monitor blood pressure, CBC, chemistry profile, LFT, renal function (e.g. serum creatinine, BUN, urine output), signs and symptoms of bleeding or gastrointestinal effects (e.g. bleeding, abdominal pain).
Overdosage
Symptoms: Nausea, vomiting, headache, epigastric pain, gastrointestinal bleeding, lethargy, drowsiness, anaphylactoid reactions. Rarely, hypertension, acute renal failure, respiratory depression and coma. Management: Symptomatic and supportive treatment. Consider emesis or administration of activated charcoal and/or osmotic cathartic within 4 hours of ingestion with symptoms or following a large oral overdose.
Drug Interactions
Increased risk of bleeding with other NSAIDs, corticosteroids, SSRIs, anticoagulants, antiplatelet agents (e.g. aspirin), and pentoxifylline. Increased plasma concentration with probenecid, lithium, cardiac glycosides (e.g. digoxin) and methotrexate. May enhance nephrotoxicity with ACE inhibitors, angiotensin II antagonists, ciclosporin, and diuretics. Increased risk of seizure with antiepileptic drugs (e.g. phenytoin, carbamazepine). Hallucination may occur when used with psychoactive drugs (e.g. fluoxetine, thiothixene, alprazolam). May enhance adverse effect (e.g. apnoea) of nondepolarizing muscle relaxants.
Food Interaction
Decreased peak concentrations and delayed time to peak concentrations with high-fat food.
Action
Description: Ketorolac, a pyrrolizine carboxylic acid derivative, is an NSAID that reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, resulting in decreased formation of prostaglandin precursors. It has antipyretic, anti-inflammatory and analgesic properties.
Onset: Analgesic: 30-60 minutes (oral); approx 30 minutes (IV/IM); within 20 minutes (nasal).
Duration: Analgesic: 4-6 hours.
Pharmacokinetics:
Absorption: Well absorbed from the gastrointestinal tract after oral administration; rapidly and completely absorbed following IM administration. Bioavailability: 100% (Oral, IM); approx. 60% (nasal). Time to peak plasma concentration: Approx 45 minutes (oral); 1-3 minutes (IV); 30-60 minutes (IM).
Distribution: Poor penetration into the cerebrospinal fluid, crosses placenta and present in breastmilk (small amounts). Volume of distribution: Approx 13 L. Plasma protein binding: 99%.
Metabolism: Metabolised in the liver via glucuronic acid conjugation and hydroxylation.
Excretion: Via urine (approx 92%; approx. 60% as unchanged drug), faeces (approx 6%). Elimination half-life: Approx 5 hours (S-enantiomer: approx 2.5 hours, R-enantiomer: 5 hours).
Chemical Structure

Chemical Structure Image
Ketorolac

Source: National Center for Biotechnology Information. PubChem Database. Ketorolac, CID=3826, https://pubchem.ncbi.nlm.nih.gov/compound/Ketorolac (accessed on Jan. 21, 2020)

Storage
Tab: Store between 20-25°C. IV/IM/ophthalmic: Store between 15-30°C. Intranasal: Unopened: Store between 2-8°C. Do not freeze. Once opened, store below 30°C. Protect from light.
ATC Classification
S01BC05 - ketorolac ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
References
Acuvail 0.45% Ophthalmic Solution (Allergan Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2019.

Acuvail 0.45% Ophthalmic Solution (Allergan Sales, LLC). MHRA. https://products.mhra.gov.uk/. Accessed 21/08/2019.

Anon. Ketorolac (Nasal). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/08/2019.

Anon. Ketorolac (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/08/2019.

Anon. Ketorolac (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/08/2019.

Buckingham R (ed). Ketorolac Trometamol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/08/2019.

Ketorolac Tromethamine 0.4% Ophthalmic Solution (Aurobindo Pharma Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2019.

Ketorolac Tromethamine 0.5% Ophthalmic Solution (Proficient Rx LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2019.

Ketorolac Tromethamine Injection (Fosun Pharma USA Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2019.

Ketorolac Tromethamine Solution for Injection (Baxter Healthcare Limited). MHRA. https://products.mhra.gov.uk/. Accessed 21/08/2019.

Ketorolac Tromethamine Spray (Egalet US Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 21/08/2019.

Ketorolac Tromethamine Tablet (Virtus Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2019.

Disclaimer: This information is independently developed by MIMS based on Ketorolac from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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