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Ketorlac (Ketorolac Tromethamine) - Summary

 
 



WARNING

Ketorolac tromethamine tablets, a non-steroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days.

Ketorolac tromethamine tablets are not indicated for use in pediatric patients and they are NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events.

GASTROINTESTINAL RISK

  • Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

CARDIOVASCULAR RISK

  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL STUDIES).
  • Ketorolac tromethamine is CONTRAINDICATED for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

RENAL RISK

  • Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS).

RISK OF BLEEDING

  • Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS).

Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.

RISK DURING LABOR AND DELIVERY

  • The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions.

CONCOMITANT USE WITH NSAIDs

  • Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.

SPECIAL POPULATIONS

  • Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS).
 

KETORLAC SUMMARY

Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs).

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Ketorolac tromethamine is indicated for the short-term (≤ 5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-I.V./.IM., and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. Combined use of ketorolac tromethamine-I.V./I.M. and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.


See all Ketorlac indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ketorlac (Ketorolac)

The Opioid Crisis and Need for Compassion in Pain Management
Source: Medscape Anesthesiology Headlines [2017.09.28]
In this commentary, the author expresses concern that the response to the public health crisis of opioid addiction is creating a growing crisis of inadequate pain management.
American Journal of Public Health

CVS to Restrict Opioid Painkiller Prescription Amounts
Source: MedicineNet Drug Abuse Specialty [2017.09.25]
Title: CVS to Restrict Opioid Painkiller Prescription Amounts
Category: Health News
Created: 9/22/2017 12:00:00 AM
Last Editorial Review: 9/25/2017 12:00:00 AM

Stomach Pain Quiz: Nausea & Other Causes
Source: MedicineNet Anal Fissure Specialty [2017.09.19]
Title: Stomach Pain Quiz: Nausea & Other Causes
Category: MedicineNet Quiz
Created: 1/20/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 5:59:56 PM

Back Pain Quiz: Test Your Back Pain IQ
Source: MedicineNet Ankylosing Spondylitis Specialty [2017.09.19]
Title: Back Pain Quiz: Test Your Back Pain IQ
Category: MedicineNet Quiz
Created: 6/16/2011 3:41:00 PM
Last Editorial Review: 9/19/2017 6:39:04 PM

Pain Quiz: Test Your IQ of Pain
Source: MedicineNet Constipation Specialty [2017.09.19]
Title: Pain Quiz: Test Your IQ of Pain
Category: MedicineNet Quiz
Created: 7/14/2011 3:53:00 PM
Last Editorial Review: 9/19/2017 6:41:41 PM

more news >>

Published Studies Related to Ketorlac (Ketorolac)

Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials. [2014]
postoperatively, but concerns over postoperative bleeding have limited its use... CONCLUSIONS: This is the first meta-analysis of randomized controlled trials

Intramuscular ketorolac versus oral ibuprofen for pain relief in first-trimester surgical abortion: a randomized clinical trial. [2014]
ketorolac for pain management during first-trimester surgical abortion... CONCLUSIONS: Intramuscular ketorolac does not offer superior pain control

Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. [2012]
randomized clinical trial... CONCLUSIONS: One month after uneventful phacoemulsification, there was no

The effect of perioperative ketorolac on pain control in pregnancy termination. [2011.11.29]
BACKGROUND: The study was conducted to evaluate the effect of perioperative ketorolac on pain associated with first-trimester aspiration abortion... CONCLUSION: Perioperative ketorolac has the same effect on postoperative pain as determined by VAS as placebo. The use of ketorolac at the 30-mg dose cannot be recommended for better pain control for patients undergoing first-trimester pregnancy termination by suction curettage. The only positive effect of the use of ketorolac compared to placebo was a reduction in the use of acetaminophen. Ketorolac use does not appear to change blood loss in the operating room or through postoperative day 1 compared to placebo. Copyright (c) 2011 Elsevier Inc. All rights reserved.

A randomized, controlled trial validates a peripheral supra-additive antihyperalgesic effect of a paracetamol-ketorolac combination. [2011.11]
The combination of paracetamol with non-steroidal anti-inflammatory drugs (NSAIDs) is widely used; however, the nature and mechanism of their interaction are still debated. A double-blind, pharmacokinetic/pharmacodynamic, randomized, cross-over, placebo-controlled study was carried out in human healthy volunteers...

more studies >>

Clinical Trials Related to Ketorlac (Ketorolac)

Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection [Completed]
Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.

more trials >>


Page last updated: 2017-09-28

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