There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=
* Condition1
<!--Warnings-->
|warnings=
* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=
* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=
* '''Pregnancy Category'''
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=
* Oral
* Intravenous
|monitoring=
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose=
===Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=
<!--Mechanism of Action-->
|mechAction=
*
<!--Structure-->
|structure=
*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
{{CMG}}
|PK=
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
==Overview==
|nonClinToxic=
'''Ketorolac''' or '''ketorolac tromethamine''' (marketed as '''Toradol''' - generics have been approved) is a [[non-steroidal anti-inflammatory drug]] (NSAID) in the family of [[propionic acid]]s, often used as an [[analgesic]], [[antipyretic]] ([[fever]] reducer), and anti-[[inflammation|inflammatory]]. Ketorolac acts by inhibiting bodily synthesis of [[prostaglandins]]. Ketorolac in its oral and intramuscular preparations is a [[racemic]] mixture of (''S'')-(−)-ketorolac, the active isomer, and (''R'')-(+)-ketorolac. An ophthalmic solution of ketorolac is available under the name Acular, and is used to treat eye pain and to relieve the itchiness and burning of seasonal allergies.
The brand name ''Toradol'' was coined by the [[Syntex]] company of the United States.
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
==Chemistry==
<!--Clinical Studies-->
Ketorolac, like other 2-arylpropionate derivatives (including [[ketoprofen]], [[flurbiprofen]], [[naproxen]], [[ibuprofen]] etc.) contains a [[chirality (chemistry)|chiral]] carbon in the α-position of the propionate moiety. As such there are two possible [[enantiomer]]s of ketorolac with the potential for different biological effects and metabolism for each enantiomer.
[[NSAID]]s are not recommended for use with other NSAIDs because of the potential for additive side effects.
|clinicalStudies=
The protein-binding effect of most non-[[aspirin]] NSAIDs is inhibited by the presence of aspirin in the blood.
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
==Mechanism of action==
<!--How Supplied-->
The primary [[mechanism of action]] responsible for Ketorolac's [[anti-inflammatory]]/[[antipyretic]]/[[analgesic]] effects is the inhibition of prostaglandin synthesis by competitive blocking of the [[cyclooxygenase|the enzyme cyclooxygenase]] (COX). Like most [[NSAID]]s, Ketorolac is a non-selective [[COX|cyclooxygenase]] inhibitor.
As with other [[NSAID]]s, the mechanism of the drug is associated with the chiral S form. Conversion of the R enantiomer into the S enantiomer has been shown to occur in the [[metabolism]] of ibuprofen; it is unknown whether it occurs in the metabolism of ketorolac.
|howSupplied=
==Indications==
*
Ketorolac is indicated for short-term management of pain (up to five days maximum).
==Contraindications==
<!--Patient Counseling Information-->
Ketorolac is contraindicated against patients with a previously demonstrated hypersensitivity to ketorolac, and against patients with the complete or partial syndrome of [[nasal polyps]], [[angioedema]], [[bronchospasm|bronchospastic]] reactivity or other [[allergy|allergic]] manifestations to aspirin or other non-steroidal anti-inflammatory drugs (due to possibility of severe [[anaphylaxis]]). As with all NSAIDs, ketorolac should be avoided in patients with renal dysfunction. (Prostaglandins are needed to dilate the afferent arteriole; NSAIDs effectively reverse this.) The patients at highest risk, especially in the elderly, are those with fluid imbalances or with compromised renal function (e.g., heart failure, diuretic use, cirrhosis, dehydration, and renal insufficiency).
==Adverse effects==
Similar to other NSAIDs. See inset "Ketorolac adverse effects."
| [[Edema]]. Less frequently, hypersensitivity reactions (such as anaphylaxis, bronchospasm, [[larynx|laryngeal]] edema, [[tongue]] edema, [[hypotension]]), [[Flushing (physiology)|flushing]], [[weight gain]], or [[fever]]. Very infrequently, [[asthenia]].
|-
! Cardiovascular
| [[Hypertension]]. Less frequently, [[palpitation]], [[pallor]], or [[syncope]].
|-
! Dermatologic
| [[Rash]] or [[pruritus]]. Less frequently, [[Lyell's syndrome]], [[Stevens-Johnson syndrome]], musculo-papular rash, [[exfoliative dermatitis]], or [[urticaria]].
|-
! Gastrointestinal
| [[Nausea]], [[dyspepsia]], [[gastrointestinal]] [[Pain and nociception|pain]], [[constipation]], [[diarrhea]], [[flatulence]], gastrointestinal fullness, [[vomit]]ing or [[stomatitis]]. Less frequently, [[peptic ulcer]]ation, gastrointestinal [[hemorrhage]], gastrointestinal perforation, [[melena]], [[rectum|rectal]] bleeding, [[gastritis]], [[eructation]], [[anorexia (symptom)|anorexia]], or increased [[appetite]]. Very infrequently, [[pancreatitis]].
|-
! Hemic and lymphatic
| [[Purpura]]. Less frequently, postoperative wound hemorrhage, [[thrombocytopenia]], [[epistaxis]], or [[anemia]]. Very infrequently, [[leukopenia]] or [[eosinophilia]].
|-
! Neurological
| [[Drowsiness]], [[dizziness]], [[headache]], [[sweating]], [[Injection (medicine)|injection]] site pain. Less frequently [[convulsion]]s, [[Vertigo (medical)|vertigo]], [[tremors]], abnormal dreams, [[hallucinations]], or [[Euphoria (emotion)|euphoria]]. Very infrequently, [[paresthesia]], [[depression (mood)|depression]], [[insomnia]], inability to concentrate, [[nervousness]], excessive thirst, dry mouth, abnormal thinking, [[hyperkinesis]], or [[stupor]].
|-
! Respiratory
| Less frequently, [[dyspnea]], [[asthma]] and [[pulmonary]] edema. Very infrequently, [[rhinitis]] or cough.
|-
! Urogenital
| Less frequently, acute [[renal failure]]. Very infrequently [[polyuria]] or increased [[urinary]] frequency.
|}
==Warnings and precautions==
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
The most serious risks associated with ketorolac are, as with other NSAIDs, gastrointestinal ulcerations, bleeding and perforation; [[kidney|renal]] events ranging from interstitial [[nephritis]] to complete [[kidney failure|renal failure]]; hemorrhage, and hypersensitivity reactions.
As with other NSAIDs, fluid and solute retention and edema have been reported with ketorolac; ketorolac elevated liver protein levels; it also inhibits platelet aggregation and may be associated with an increased risk of bleeding.
<!--Precautions with Alcohol-->
It should be noted that when administered intravenously through the same IV catheter as Morphine the two drugs have been known to sometimes combine to form a precipitate in the IV, which may block the line. Line flushing with a syringe of saline can push the blockage through.
|alcohol=
==Cautions==
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Ketorolac is not recommended for pre-[[Surgery|operative]] analgesia or co-administration with [[anesthesia]] because it inhibits platelet aggregation.
Ketorolac is not recommended for [[obstetrics|obstetric]] analgesia because it has not been adequately tested for obstetrical administration and has demonstrable fetal toxicity in laboratory animals.
<!--Brand Names-->
Ketorolac has been co-administered with [[meperidine]] and [[morphine]] without apparent adverse effects.
|brandNames=
Ketorolac is not recommended for long-term chronic pain patients.
* ®<ref>{{Cite web | title = | url = }}</ref>
==Dosage, availability and price==
<!--Look-Alike Drug Names-->
Oral dosage is 10 mg; United States price for 20 tablets hovers around US$28. Australian pricing for 20 tablets is around AU$43.39.<ref name="epharmacy">{{cite web | url = http://www.epharmacy.com.au/searchresults.asp?searchsection=products&terms=toradol&stype=NP&expand=0 | title = Search for Toradol | publisher = ePharmacy | accessdate = 2007-10-16}}</ref>
Injected dosages are 15, 30 and 60 mg; United States price for 10 vials of 30 mg each is around US$45, making the [[wikt:Intramuscular|intramuscular]] preparation considerably more expensive per dose. One 60-mg dose would require the administration by injection of two vials, at about $9 per dose. Australian pricing for 5 vials is around AU$57.90<ref name="epharmacy"/>, or $23.16 per dose. Ketorolac is not available on the [[Pharmaceutical Benefits Scheme]].<ref>{{cite web | url = http://www.pbs.gov.au/html/consumer/search/results?medicine=ketorolac | title = Search for Ketorolac | publisher = Pharmaceutical Benefits Scheme | accessdate = 2007-10-16}}</ref>
|lookAlike=
In the United States<ref>{{cite web | url = http://redpoll.pharmacy.ualberta.ca/drugbank/drugBank/FDA_labels/019700.pdf | title = FDA Label for Ketorolac | publisher = US Food and Drug Administration | year = 2004 | accessdate = 2007-10-16}}</ref>, United Kingdom<ref>{{cite web | url = http://www.netdoctor.co.uk/medicines/effect/pain/prescription_only_medicines.shtml | title = Pain: prescription-only medicines | publisher = NetDoctor.co.uk | accessdate = 2007-10-16 | year = 2007}}</ref>, Canada<ref>{{cite web | url = http://www.smartmed.ca/content/search.asp?txtsearch=Ketorolac | title = Prescription Drug Search | publisher = Smart Med Canada | accessdate = 2007-10-16}}</ref> and Australia<ref>{{cite web | url = http://www.roche-australia.com/downloads/toradol-pi.cfm?action=get | title = Toradol (ketorolac trometamol) Product Information | year = 2005 | publisher = Roche Australia | accessdate = 2007-10-16}}</ref> this drug cannot be sold [[OTC|over-the-counter]] and must be administered only with a [[Medical prescription|prescription]].
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
[[Syntex|SYNTEX (U.S.A.) L.L.C.]], Palo Alto, California, U.S.A. developed the ophthalmic solution Acular, and holds the registered trademark on that name. The brand name Acular product is manufactured and distributed by [[Allergan]], Inc., under license from Syntex.<ref name="Allergan Acular info">{{cite web | last = Allergan | authorlink = Allergan | year = 2006 | url = http://www.allergan.com/site/products/consumers/home.asp?id=acular | title = ACULAR Ketorolac tromethamine 0.5% ophthalmic solution Product Information | work = Allergan web site | publisher = Allergan | accessdate = 2006-05-08}}</ref>
<!--Drug Shortage Status-->
[[Apotex]] Products Group, a Canadian manufacturer, offers [[generic drug|generic]] Ketorolac tromethamine 0.5% ophthalmic solution under the name "APO-KETOROLAC"<ref name="Apotex Ketorolac-ophthalmic info">{{cite web
|drugShortage=
| last = Apotex Products Canada | authorlink = Apotex | date = [[2006-05-08]] | url = http://www.apotex.ca/Products/EN/Detail.asp?MaterialNumber=000000000000043869 | title = APO-KETOROLAC Product Information | work = Apotex Products Canada Product Catalogue | publisher = Apotex Products Canada | accessdate = 2006-05-08}}</ref> in Canada and some other countries.
}}
Syntex and Allergan sued Apotex for patent infringement of U.S. Patent No. 5,110,493 over the generic Ketorolac tomethamine product. In May, 2005, the United States court of appeals for the Federal Circuit handed Apotex a victory, ruling that a lower court upholding the Syntex patent misapplied the rules for judging whether an invention was obvious. Allergan claims the patent is valid until 2009.<ref name="Patent Baristas Ketorolac">{{cite web | last = Albainy-Jenei | first = Stephen R. | date = May 24, 2005 | url = http://www.patentbaristas.com/archives/000188.php | title = Federal Circuit Reverses Allergan's Patent Validity Decision | work = Patent Baristas web log | accessdate = 2006-05-08}}</ref>
* [http://www.medicinenet.com/ketorolac_tromethamine-ophthalmic/article.htm medicinenet.com information on ketorolac tromethamine - ophthalmic (Acular)]
|NDC=
* [http://www.druglib.com/druginfo/toradol/abstracts/ Druglib published studies related to Toradol (Ketorolac)]
|drugAuthor=
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==References==
<!--Label Display Image-->
{{reflist|2}}
* Handley, D.A., P. Carvoni, J.E. McCray, J.R. McCullough (1998). "Preclinical Enantioselective Pharmacology of (R)- and (S)- Ketorolac.", ''J Clin Pharmacol'' '''38''', 25-35.
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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Ketorolac tromethamine (oral) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ketorolac tromethamine (oral) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketorolac tromethamine (oral) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Ketorolac tromethamine (oral) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ketorolac tromethamine (oral) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketorolac tromethamine (oral) in pediatric patients.
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ketorolac tromethamine (oral) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ketorolac tromethamine (oral) in the drug label.
There is limited information regarding Patient Counseling Information of Ketorolac tromethamine (oral) in the drug label.
Precautions with Alcohol
Alcohol-Ketorolac tromethamine (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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