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Sprix Generic Name & Formulations
Legal Class
Rx
General Description
Ketorolac tromethamine 15.75mg; per 100μL nasal spray; contains EDTA.
Pharmacological Class
NSAID (pyrrolo-pyrrole).
How Supplied
Single-day nasal spray bottle (8 sprays/1.7g bottle)—1, 5
Manufacturer
Sprix Indications
Indications
For the short-term (up to 5 days) management of moderate-to-moderately severe pain that requires analgesia at the opioid level.
Limitations of Use
Not for use in children <2yrs of age.
Sprix Dosage and Administration
Adult
Use lowest effective dose for shortest duration. 18–64yrs: 1 spray in each nostril (total dose: 31.5mg) every 6–8hrs; max daily dose 126mg (4 doses). ≥65yrs, renally-impaired, or <50kg: 1 spray in one nostril (total dose: 15.75mg) every 6–8hrs; max daily dose 63mg (4 doses). Discard used bottle after 24hrs.
Children
≤17yrs: not established.
Sprix Contraindications
Contraindications
Active peptic ulcer, recent GI bleed or perforation. Cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or for whom hemostasis is critical. Aspirin allergy. Pre-op use. Coronary artery bypass graft surgery. Advanced renal disease or at risk for renal failure due to volume depletion. Concomitant probenecid, pentoxifylline. Labor & delivery.
Sprix Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Sprix Warnings/Precautions
Warnings/Precautions
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Inflammatory bowel disease (eg, ulcerative colitis, Crohns disease). Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Avoid spraying into eyes. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation; Cat.D ≥30 weeks gestation: avoid). Nursing mothers.
Sprix Pharmacokinetics
See Literature
Sprix Interactions
Interactions
See Contraindications. Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Possible seizures with phenytoin, carbamazepine. Possible hallucinations with fluoxetine, thiothixene, alprazolam. Caution with nondepolarizing muscle relaxants; monitor for apnea.
Sprix Adverse Reactions
Adverse Reactions
Nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash (may be serious), bradycardia, decreased urine output, increased ALT/AST, hypertension, rhinitis; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.
Sprix Clinical Trials
See Literature
Sprix Note
Not Applicable
Sprix Patient Counseling
See Literature
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