Adult Dosing

Short term (up to 5 days) management of moderate to moderately severe pain

• <65 years: 31.5 mg (ie, 1 spray in each nostril) q6-8 hrs; Max: 126 mg/day
• <50 kg or 65 years or older: 15.75 mg (ie, 1 spray in only 1 nostril) q6-8 hrs; Max: 63 mg/day

Note:

• Discard within 24 hours of taking the first dose, even if the bottle still contains some medication

Pediatric Dosing

• Safety and effectiveness have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to aspirin or other NSAIDs or ethylenediamine tetraacetic acid
• Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Total duration of use of intranasal alone or with other ketorolac formulations should not exceed 5 days
• Use as a prophylactic analgesic before any major surgery
• Peptic ulcer disease or hx of GI bleeding
• Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding
• Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
• Advanced renal impairment
• Patients at risk for renal failure due to volume depletion
• Use in labor and delivery
• Breastfeeding, because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates
• Concomitant use with probenecid, pentoxifylline

• Total duration of use of ketorolac intranasal, alone or sequentially with other ketorolac formulations (IM/IV or oral), should not exceed 5 days
• Not indicated for use in pediatric patients and is not indicated for minor or chronic painful conditions
• Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines any time during use and without warning symptoms, which can be fatal. Use 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
• Use is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk
• Contraindicated in treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
• Contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion

Renal Dose Adjustment

• 1 spray (15.75 mg) in 1 nostril q6-8 hrs; Max: 63 mg/day
• Advanced impairment: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

• Total duration of use of ketorolac intranasal, alone or sequentially with other ketorolac formulations (IM/IV or oral), should not exceed 5 days [US blackbox warning]
• Not indicated for use in pediatric patients and is not indicated for minor or chronic painful conditions [US blackbox warning]
• Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines any time during use and without warning symptoms, which can be fatal. Use 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 [US blackbox warning]
• Use is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding [US blackbox warning]
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [US blackbox warning]
• Contraindicated in treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [US blackbox warning]
• Contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion [US blackbox warning]
• Use lowest effective dose for the shortest possible duration to minimize the potential risk for an adverse GI event. Promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. Use cautiously in patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated
• Patients on therapeutic doses of anticoagulants have an increased risk of bleeding complications if given ketorolac tromethamine concurrently; therefore, administer such concomitant therapy only with extreme caution
• Use with caution in patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics or ACE inhibitors, and the elderly
• Long-term use of NSAIDs has resulted in renal papillary necrosis and other renal injury such as interstitial nephritis and nephrotic syndrome
• Anaphylactoid reactions may occur in patients with or without a history of allergic reactions to aspirin or NSAIDs and in patients without known prior exposure to ketorolac. Discontinue immediately in patients with allergic reactions
• Should not be given to patients with aspirin triad
• NSAIDs can lead to onset of new hypertension or worsening of preexisting hypertension. Closely monitor patients taking thiazides or loop diuretics
• Fluid retention, edema, retention of NaCl, oliguria, and elevations of serum urea nitrogen and creatinine have been reported with ketorolac. Use cautiously in patients with cardiac decompensation or similar conditions
• Ketorolac can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal
• Starting at 30 weeks gestation it can cause fetal harm when administered to a pregnant woman due to an increased risk of premature closure of the ductus arteriosus
• Use cautiously in patients with impaired hepatic function or a history of liver disease. Borderline elevations of one or more liver tests may occur
• Cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported with ketorolac
• Evaluate patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, for evidence of the development of a more severe hepatic reaction while on therapy
• Use of aspirin in patients with aspirin sensitive asthma has been associated with severe bronchospasm which can be fatal; use with caution in patients with preexisting asthma
• Avoid contact with eye. If eye contact occurs, wash out the eye with water or saline, and consult a physician if irritation persists for more than an hour

Sprix interacts with :

	A-hydrocort
	A-methapred
	ACE Inhibitors
	Acenocoumarol
	Ala-Cort
	Aldactone
	Anafranil
	Angiotensin Receptor Blockers
	Anticancer Doses
	Anusol HC
	ARBs
	Aristocort
	Aveeno Hydrocortisone Anti-Itch Cream
	Azmacort
	Brintellix
	Brisdelle
	Celexa
	Citalopram
	Clomipramine
	Colocort
	Cortaid Advanced
	Cortaid Maximum Strength
	Cortef
	Cortenema
	Cortifoam
	Cortisone
	Cortizone-10
	Cortizone-10 Hydratensive
	Cortizone-10 Intensive Healing Eczema
	Cortizone-10 Plus
	Cortone
	Coumadin
	Cymbalta
	DDAVP
	Decadron
	Depo-Medrol
	Desmopressin
	Desvenlafaxine
	Dexamethasone
	Duloxetine
	Effexor
	Effexor XR
	Eplerenone
	Escitalopram
	Eskalith
	Fetzima
	Flo-Pred
	Fluoxetine
	Fluvoxamine
	Folotyn
	Hydrocortisone
	Imipramine
	Inspra
	Jantoven
	Kenalog
	Kenalog-10
	Kenalog-40
	Khedezla
	Levomilnacipran
	Lexapro
	Lithium
	Lithobid
	Locoid
	Locoid lipocream
	Luvox
	Luvox CR
	Maxidex
	Medrol
	Methotrexate
	Methylprednisolone
	Micort-HC
	Millipred
	Milnacipran
	Monistat Soothing Care Itch Relief Cream
	Nasacort allergy 24 Hour
	Nasacort AQ
	Nefazodone
	Nutracort
	Omnipred
	Orabase HCA
	Orapred
	Orapred ODT
	Otrexup
	Ozudrex
	Pandel
	Paroxetine
	Paxil
	Paxil CR
	Pexeva
	Phenprocoumon
	Pralatrexate
	Pred forte
	Pred mild
	Prednisolone
	Prednisone
	Prelone
	Preparation H Anti-Itch Cream
	Pristiq
	Proctosol-HC
	Prozac
	Prozac Weekly
	Rayos
	Rheumatrex Dose Pack
	Sarafem
	Savella
	Selfemra
	Sertraline
	Solu Cortef
	Solu-Medrol
	Spironolactone
	Sterapred
	Sterapred DS
	Stie-Cort
	Synacort
	Texacort
	Tofranil
	Tofranil-PM
	Trexall
	Triacet
	Triamcinolone
	Triderm
	Triesence
	U-Cort
	Venlafaxine
	Veripred 20
	Viibryd
	Vilazodone
	Vortioxetine
	Warfarin
	Westcort
	Zoloft

Pregnancy Category:C (D in third trimester)

Breastfeeding: Contraindicated.

• EENT: Nasal discomfort, rhinalgia, lacrimation increased, throat irritation
• GU:Oliguria, urine output decreased
• DERM: Rash, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
• CV: Bradycardia, CV thrombotic events, myocardial infarction, stroke
• HEPA: Jaundice, fulminant hepatitis, liver necrosis, hepatic failure
• GI: GI blood loss, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, dyspepsia
• HEMA: Anemia
• LAB TESTS: ALT and/or AST increased, elevations of serum urea nitrogen and creatinine
• HYPERSENSITIVITY: Anaphylactoid reactions
• MISCELLANEOUS: Fluid retention, edema

• Analgesic; inhibits enzyme cylooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced synthesis of prostaglandins, thromboxanes, and prostacyclin
• Bioavailability: 60% (compared with 30 mg IM)
• Metabolism: By liver via hydroxylation and conjugation
• Excretion: urine 92% (40% as metabolites and 60% unchanged); feces (6%)
• Half-Life: 2.5 hrs for S-enantiomer; 5 hours for R-enantiomer

US Trade Name(s)

• Sprix

US Availability

Sprix

• Metered nasal SPRAY: 15.75 mg/spray

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Analgesics

NSAIDs