WARNING
Ketorolac tromethamine, a non-steroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days) management of moderately severe, acute pain, that requires analgesia at the opioid level. It is NOT indicated for minor or chronic painful conditions. Ketorolac tromethamine is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.
Cardiovascular Risk
- NSAIDs1 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.)
- Ketorolac tromethamine tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (See WARNINGS.)
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS.)
Renal Effects
- 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, and is CONTRAINDICATED intra-operatively when hemostasis is critical because of the increased risk of bleeding.
Hypersensitivity
- Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine-I.V./I.M. (see CONTRAINDICATIONS and WARNINGS). It is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine, or allergic manifestations to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
Labor, Delivery, and Nursing
- The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and inhibit uterine contractions.
- The use of ketorolac tromethamine is CONTRAINDICATED in nursing mothers because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates.
Concomitant Use with NSAIDs
- Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
Dosage and Administration
Ketorlac Tromethamine Tablets
- Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine-I.V./I.M., and the combined duration of use of ketorolac tromethamine-I.V./I.M. and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events.
- The recommended totally daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine-I.V./I.M. (maximum 120 mg) (see DOSAGE AND ADMINISTRATION and Transition from Ketorolac Tromethamine-I.V./I.M. to Ketorolac Tromethamine Tablets).
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). Doses of ketorolac tromethamine-I.V./I.M. are not to exceed 60 mg (total dose per day) in these patients.
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KETORLAC SUMMARY
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg
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.
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NEWS HIGHLIGHTSMedia Articles Related to Ketorlac (Ketorolac)
Erectile Dysfunction Tied To Long Term Painkiller Use
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.16]
A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine. Lead author Richard A...
Painkillers Increase Risk of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.15]
Regularly taking prescription painkillers, commonly called opioids, is linked to a greater risk of erectile dysfunction (ED) in men, according to a new study published in Spine. Over 11,000 men suffering from back pain were involved in the research...
Retooling Pain Assessment for Older Adults
Source: Medscape Emergency Medicine Headlines [2013.05.14]
Current pain assessment tools for older adults are inadequate, and education for healthcare professionals falls short in meeting the unique challenges posed by pain management for elderly patients.
Medscape Medical News
Tanezumab Makes Good in Chronic Back Pain (CME/CE)
Source: MedPage Today Neurology [2013.05.14]
NEW ORLEANS (MedPage Today) -- The controversial agent tanezumab, which was once put on an FDA regulatory hold, offered durable reduction of chronic low back pain, a long-term safety and efficacy study showed.
Persistent Pain After Sexual Assault Often Untreated
Source: Medscape Nurses Headlines [2013.05.13]
Although pain is common after sexual assault, more than 50% of women don't seek appropriate medical care 6 weeks after presenting to the ED.
Medscape Medical News
Published Studies Related to Ketorlac (Ketorolac)
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...
Preemptive analgesic effectiveness of oral ketorolac plus local tramadol after impacted mandibular third molar surgery. [2011.09.01]
OBJECTIVE: The aim of this study was to compare preemptive analgesia of oral ketorolac plus submucous local placebo with oral ketorolac plus submucous local tramadol after impacted mandibular third molar surgery... CONCLUSIONS: Preemptive use of oral ketorolac plus submucous local tramadol is an alternative treatment for acute pain after surgical removal of an impacted mandibular third molar.
A double-blind placebo-controlled comparison of a novel formulation of intravenous diclofenac and ketorolac for postoperative third molar extraction pain. [2011.06]
Dyloject is a novel formulation of diclofenac intended for intravenous (IV) administration...
Clinical Trials Related to Ketorlac (Ketorolac)
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery [Completed]
This study evaluates the safety and efficacy of ketorolac for post-operative pain management
after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing
the requirements for morphine during the (immediate) 24-hour post-operative period.
Topical 0.4% Ketorolac and Vitreoretinal Surgery [Completed]
To determine whether use of topical 0. 4% ketorolac has any effect on pupil size during
vitreoretinal surgery.
Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation [Withdrawn]
The purpose of this study is to determine how the drug ketorolac, when given with the spinal
morphine, affects pain.
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy [Recruiting]
The purpose of this study is to determine whether continuous intravenous ketorolac infusion
reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone
disease.
Disposition of Intravenous Ketorolac [Not yet recruiting]
The purpose of this study is:
- to document ketorolac disposition (concentration/time profile, protein binding,
metabolism) and its covariates following intravenous (iv) administration of ketorolac
right after caesarean section and to compare those observations (n=32) with
non-pregnant state (n=8) (intra-subject PK comparison)
- to document biochemical tolerance of ketorolac
- to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are
appropriated and needed
- to quantify the neonatal exposure to ketorolac through excretion in the breast milk
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Page last updated: 2013-05-16
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