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Caldolor
ibuprofen
Black Box Warnings .
Cardiovascular Thrombotic Event
NSAIDs incr. risk of serious and potentially fatal cardiovascular thrombotic events, including MI and stroke; risk may occur early in tx and may incr. with duration of use; contraindicated in CABG periop setting
GI Bleeding, Ulceration, and Perforation
NSAIDs incr. risk of serious and potentially fatal GI adverse events including bleeding, ulcer, and stomach or intestine perforation; GI events may occur at any time during use and without warning symptoms; elderly patients and patients with history of PUD or GI bleeding at greater risk for serious GI events
Adult Dosing .
Dosage forms: INJ
pain
- [400-800 mg IV q6h prn]
- Max: 3200 mg/day; Info: use lowest effective dose, shortest effective tx duration; may use with opioids for moderate-severe pain
fever
- [400 mg IV q4-6h prn]
- Max: 3200 mg/day; Alt: 400 mg IV x1, then 100-200 mg IV q4h prn; Info: use lowest effective dose, shortest effective tx duration
renal dosing
- [see below]
- CrCl >60: no adjustment; CrCl 30-60: not defined, caution advised; CrCl <30: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: INJ
pain
- [3-5 mo]
- Dose: 10 mg/kg/dose IV x1; Max: 10 mg/kg/dose up to 100 mg/dose; Info: may use with opioids for moderate-severe pain
- [6 mo-11 yo]
- Dose: 10 mg/kg/dose IV q4-6h prn; Max: 400 mg/dose; 40 mg/kg/day up to 2400 mg/day; Info: use lowest effective dose, shortest effective tx duration; may use with opioids for moderate-severe pain
- [12-17 yo]
- Dose: 400 mg IV q4-6h prn; Max: 40 mg/kg/day up to 2400 mg/day; Info: use lowest effective dose, shortest effective tx duration; may use with opioids for moderate-severe pain
fever
- [3-5 mo]
- Dose: 10 mg/kg/dose IV x1; Max: 10 mg/kg/dose up to 100 mg/dose
- [6 mo-11 yo]
- Dose: 10 mg/kg/dose IV q4-6h prn; Max: 400 mg/dose; 40 mg/kg/day up to 2400 mg/day; Info: use lowest effective dose, shortest effective tx duration
- [12-17 yo]
- Dose: 400 mg IV q4-6h prn; Max: 40 mg/kg/day up to 2400 mg/day; Info: use lowest effective dose, shortest effective tx duration
renal dosing
- [see below]
- CrCl >60: no adjustment; CrCl 30-60: not defined, caution advised; CrCl <30: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to ASA
- hypersensitivity to NSAIDs
- asthma, ASA-induced
- asthma, NSAID-induced
- urticaria, ASA-induced
- urticaria, NSAID-induced
- aspirin triad
- CrCl <30
- renal disease, advanced
- pregnancy starting at 30 wk gestation
- CABG surgery periop use
- MI, recent
- CHF, severe
- GI bleeding
- GI bleeding history
- PUD history
- dehydration
- hypovolemia
- caution: pregnancy at <30 wk gestation
- caution: elderly patients
- caution: debilitated patients
- caution: renal impairment
- caution: hepatic impairment
- caution: cardiovascular disease
- caution: cardiac disease risk
- caution: HTN
- caution: CHF
- caution: fluid retention
- caution: coagulation disorder
- caution: asthma
- caution: alcohol use, concurrent
- caution: smokers
- caution: prolonged use
- caution: patients of childbearing potential trying to conceive
Drug Interactions .
Overview
ibuprofen
NSAID
- OAT1 inhibitor
- OAT3 inhibitor
- affects growth hormone diagnostic test results
- alters gallbladder contraction/motility
- antiplatelet effects
- bioavailability increased by hydroxypropyl betadex
- decreases renal perfusion/fxn
- GI mucosal injury/bleeding risk
- hyperkalemia
- hypertensive effects
- hyponatremia
- lowers seizure threshold
- thrombogenic effects
Contraindicated
- ketorolac
Avoid/Use Alternative
- amikacin
- aspirin
- bumetanide
- celecoxib
- clofarabine
- diclofenac
- diclofenac topical
- diflunisal
- enoxaparin
- epinephrine inhaled
- etodolac
- fenoprofen
- flurbiprofen
- fondaparinux
- ibuprofen
- ibuprofen lysine
- indomethacin
- ketoprofen
- lisinopril
- macimorelin
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- methotrexate
- methyl salicylate topical
- midodrine
- nabumetone
- naproxen
- oxaprozin
- pemetrexed
- piroxicam
- potassium chloride
- pralatrexate
- salsalate
- sulindac
- tacrolimus
- tenofovir disoproxil
- tolmetin
- tranexamic acid
- vaccinia immune globulin
- valsartan
- willow bark
Monitor/Modify Tx
- abemaciclib
- abiraterone acetate
- abrocitinib
- acalabrutinib
- acebutolol
- acyclovir
- adefovir dipivoxil
- ado-trastuzumab emtansine
- afatinib
- aflibercept
- albuterol
- albuterol inhaled
- aldesleukin
- alendronate
- aliskiren
- almotriptan
- alpha-tocopherol (vitamin E)
- alprostadil intracavernous
- alprostadil intravenous
- alteplase
- amikacin inhaled
- amiloride
- aminocaproic acid
- amlodipine
- amphetamine
- amphotericin
- anacaulase topical
- anagrelide
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- antithrombin
- apixaban
- aprocitentan
- arformoterol inhaled
- argatroban
- armodafinil
- asciminib
- asparaginase
- atenolol
- atidarsagene autotemcel
- atogepant
- atomoxetine
- atropine ophthalmic
- auranofin
- avapritinib
- avatrombopag
- axitinib
- azilsartan medoxomil
- balsalazide
- baricitinib
- bazedoxifene
- benazepril
- benzphetamine
- betamethasone
- betaxolol
- bevacizumab
- binimetinib
- bismuth subsalicylate
- bisoprolol
- bivalirudin
- botulism immune globulin
- brentuximab vedotin
- brigatinib
- brolucizumab
- bromelain
- bromfenac ophthalmic
- budesonide
- bupropion
- C1 esterase inhibitor
- cabazitaxel
- cabozantinib
- caffeine
- caffeine citrate
- calaspargase
- candesartan cilexetil
- cangrelor
- cannabis
- capecitabine
- caplacizumab
- captopril
- carboplatin
- carfilzomib
- carvedilol
- chlorothiazide
- chlorthalidone
- chorionic gonadotropin
- cidofovir
- cilostazol
- cinacalcet
- cisplatin
- citalopram
- cladribine oral
- clevidipine
- clindamycin
- clonidine
- clopidogrel
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- cocaine
- colistimethate
- collagenase clostridium histolyticum
- concizumab
- copanlisib
- copper histidinate
- corticotropin
- cortisone
- creatine
- cyclophosphamide
- cyclosporine
- cysteamine
- cytomegalovirus immune globulin
- dabigatran
- dalteparin
- danazol
- danshen
- darbepoetin alfa
- dasatinib
- decitabine
- deferasirox
- deferoxamine
- defibrotide
- deflazacort
- desmopressin
- desogestrel (contraceptive)
- desvenlafaxine
- deuruxolitinib
- dexamethasone
- dexmethylphenidate
- dextroamphetamine
- diclofenac ophthalmic
- dienogest (contraceptive)
- diethylpropion
- digoxin
- dihydroergotamine
- diltiazem
- dimethyl fumarate
- diosmin
- dipyridamole
- diroximel fumarate
- dobutamine
- donepezil
- dopamine
- doxapram
- doxazosin
- dronabinol
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- droxidopa
- duloxetine
- edoxaban
- eletriptan
- eltrombopag
- enalapril
- enalaprilat
- encorafenib
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- epirubicin
- eplerenone
- epoetin alfa
- epoprostenol
- eptifibatide
- eptinezumab
- erenumab
- ergotamine
- erlotinib
- escitalopram
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- etelcalcetide
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etrasimod
- evening primrose oil
- everolimus
- factor XIII concentrate
- faricimab
- fedratinib
- felodipine
- fenfluramine
- fenofibrate
- fenofibric acid
- fenoldopam
- fenugreek
- fibrinogen (human)
- finerenone
- fingolimod
- fitusiran
- flucytosine
- fludrocortisone
- fluoxetine
- flurbiprofen ophthalmic
- fluvoxamine
- follitropin
- formoterol inhaled
- foscarnet
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- furosemide
- galantamine
- galcanezumab
- ganciclovir
- garlic
- gefitinib
- gemtuzumab ozogamicin
- gentamicin
- ginkgo
- guanfacine
- heparin
- hepatitis B immune globulin
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- ibandronate
- ibrutinib
- icosapent ethyl
- ifosfamide
- imatinib
- immune globulin
- indapamide
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- irbesartan
- isradipine
- ketamine
- ketorolac ophthalmic
- labetalol
- landiolol
- lanreotide
- lanthanum
- lazertinib
- leflunomide
- lenalidomide
- lenvatinib
- levalbuterol inhaled
- levomilnacipran
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- licorice
- lifileucel
- lisdexamfetamine
- lithium
- lomustine
- lorlatinib
- losartan
- lumacaftor/ivacaftor
- luspatercept
- lusutrombopag
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- magnesium citrate
- mannitol
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- megestrol
- menotropins
- mesalamine
- mesalamine rectal
- methamphetamine
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- metoprolol
- milnacipran
- minoxidil
- mirabegron
- mitomycin
- mitotane
- modafinil
- moexipril
- momelotinib
- monomethyl fumarate
- mycophenolate mofetil
- mycophenolic acid
- nadolol
- naratriptan
- nattokinase
- naxitamab
- nebivolol
- necitumumab
- neomycin
- nepafenac ophthalmic
- niacin (vitamin B3)
- nicardipine
- nicotine
- nifedipine
- nilotinib
- nimodipine
- nintedanib
- niraparib
- nisoldipine
- norelgestromin (contraceptive)
- norepinephrine
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- nusinersen
- obinutuzumab
- olaparib
- olmesartan medoxomil
- olodaterol inhaled
- olsalazine
- omega-3-acid
- osilodrostat
- ospemifene
- oxaliplatin
- oxymetazoline nasal
- oxytocin
- ozanimod
- pacritinib
- pamidronate
- paromomycin
- paroxetine
- pazopanib
- pegaspargase
- penicillamine
- penicillin G
- pentamidine
- pentosan polysulfate sodium
- pentostatin
- pentoxifylline
- perindopril
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- piperacillin
- pirtobrutinib
- plasminogen, human
- plazomicin
- polyethylene glycol
- polyethylene glycol/electrolytes
- polymyxin B
- pomalidomide
- ponatinib
- ponesimod
- porfimer
- potassium acid phosphate
- potassium bicarbonate
- potassium citrate
- potassium iodide
- potassium phosphate
- pralsetinib
- prasugrel
- prazosin
- prednisolone
- prednisone
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- propranolol
- prothrombin complex concentrate (human)
- pseudoephedrine
- pyridostigmine
- quetiapine
- quinapril
- raloxifene
- ramipril
- ramucirumab
- ranibizumab
- regorafenib
- remibrutinib
- resveratrol
- reteplase
- revakinagene taroretcel
- Rho(D) immune globulin
- rimegepant
- ripretinib
- risedronate
- ritlecitinib
- rituximab
- rivaroxaban
- rivastigmine
- rizatriptan
- romiplostim
- ropeginterferon alfa-2b
- ropinirole
- rotigotine transdermal
- ruxolitinib
- ruxolitinib topical
- salmeterol inhaled
- saw palmetto
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sepiapterin
- sertraline
- sincalide
- siponimod
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- sitagliptin
- sodium tetradecyl sulfate
- solriamfetol
- sorafenib
- sotatercept
- sparsentan
- spironolactone
- streptomycin
- streptozocin
- sulfate bowel prep
- sumatriptan
- sunitinib
- tagraxofusp
- tamoxifen
- telavancin
- telmisartan
- temsirolimus
- tenecteplase
- tenofovir alafenamide
- terazosin
- terbutaline
- teriflunomide
- testosterone
- thalidomide
- ticagrelor
- timolol
- tiopronin
- tipranavir
- tirofiban
- tisotumab vedotin
- tivozanib
- tobramycin
- tobramycin inhaled
- tocilizumab
- tofacitinib
- tolvaptan
- toremifene
- torsemide
- tovorafenib
- trametinib
- trandolapril
- trazodone
- treprostinil
- tretinoin
- triamcinolone
- triamterene
- trimethoprim
- ubrogepant
- upadacitinib
- vadadustat
- valacyclovir
- valganciclovir
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- vancomycin
- vandetanib
- varicella zoster immune globulin
- vasopressin
- venlafaxine
- verapamil
- vilanterol inhaled
- vilazodone
- viloxazine
- vinpocetine
- voclosporin
- von Willebrand factor
- vorapaxar
- voriconazole
- vorinostat
- vortioxetine
- warfarin
- yohimbe
- zanubrutinib
- zavegepant
- ziv-aflibercept
- zoledronic acid
- zolmitriptan
- zonisamide
- zopapogene imadenovec
Caution Advised
- carbamazepine
- ciprofloxacin
- delafloxacin
- emtricitabine
- levofloxacin
- moxifloxacin
- ofloxacin
Adverse Reactions .
Serious Reactions
- GI bleeding
- GI perforation
- GI ulcer
- hemorrhage
- thrombocythemia
- anemia
- prolonged bleeding time
- MI
- stroke
- thromboembolism
- HTN
- CHF
- CHF exacerbation
- hepatotoxicity
- nephrotoxicity
- renal papillary necrosis
- hypersensitivity reaction
- anaphylaxis
- exfoliative dermatitis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug reaction with eosinophilia and systemic symptoms
- generalized bullous fixed drug eruption
- aseptic meningitis
- hyperkalemia
Common Reactions
- nausea
- vomiting
- flatulence
- headache
- hemorrhage
- dizziness
- urinary retention
- anemia
- dyspepsia
- hypokalemia
- Hgb decr.
- wound hemorrhage
- peripheral edema
- abdominal discomfort
- cough
- diarrhea
- hypoproteinemia
- hypotension
- BUN elevated
- hypernatremia
- thrombocythemia
- ALT or AST elevated
- visual disturbance
- photosensitivity
- delayed ovulation
Safety/Monitoring .
Monitoring Parameters
Cr at baseline, then if renal or hepatic impairment, CHF, dehydration, or hypovolemia continue periodically; BP during tx start, then periodically; CBC, chemistry profile if long-term tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit if <30 wk gestation, especially at 20-29 wk gestation, avoid use starting at 30 wk gestation; if must use at 20-29 wk gestation, limit dose and duration, and consider monitoring amniotic fluid if use >48h; risk of embryo-fetal toxicity and death low in 1st trimester based on conflicting human data; risk of fetal harm, including renal dysfunction and oligohydramnios, starting at 20 wk gestation and premature ductus arteriosus closure, starting at 30 wk gestation, based on human data with NSAID class and drug's mechanism of action
Individuals of Reproductive Potential
weigh risk/benefit in patients of childbearing potential trying to conceive, especially if long-term use; NSAIDs may reversibly delay ovulation during tx based on limited human or animal data and drug's mechanism of action
Lactation
Clinical Summary
may use while breastfeeding; NSAID of choice for analgesic use while breastfeeding; no known risk of infant harm or adverse effects on milk production based on human data
Pharmacology .
Metabolism: for ibuprofen: liver; CYP450: 2C9 substrate
Excretion: for ibuprofen: urine 45-79% (1% unchanged); Half-life: 2.2-2.4h (adults), 1.3-1.8h (peds)
Subclass: Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Mechanism of Action
for ibuprofen: exact mechanism of action unknown; inhibits cyclooxygenase, reducing prostaglandin and thromboxane synthesis
Formulary .
No Formulary Selected
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