SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. (1)
DOSAGE AND ADMINISTRATION

• For adult patients < 65 years of age: 31.5 mg (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg. (2.2)
• For patients ≥ 65 years of age, renally impaired patients, and patients less than 50 kg (110 lbs): 15.75 mg (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg. (2.3)
• SPRIX has not been shown to be safe and effective in pediatric patients. (2.1)
• SPRIX nasal spray should be discarded within 24 hours of taking the first dose, even if the bottle still contains some medication. (2.4)

Nasal spray: 15.75 mg of ketorolac tromethamine in each 100 μL spray. Each 1.7 g bottle contains 8 sprays. (3)
CONTRAINDICATIONS

• SPRIX should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs. (5.1)
• Ketorolac can cause serious GI adverse events including bleeding, ulceration, and perforation. SPRIX should be prescribed with caution in patients with a prior history of ulcer disease or GI bleeding. Elderly patients are at greater risk for serious GI events. (4, 5.2)
• NSAIDs affect platelet aggregation and may cause bleeding complications. SPRIX should be used with caution in patients who have coagulation disorders or are on therapy that affects hemostasis. Do not use SPRIX in patients for whom hemostasis is critical. (4, 5.3)
• Ketorolac can cause renal injury. SPRIX should not be used in patients with advanced renal disease or patients at risk for renal failure due to volume depletion, and should be used with caution in patients taking diuretics or ACE inhibitors. (4, 5.4, 12.4)
• Anaphylactoid reactions may occur in patients with or without a history of allergic reactions to aspirin or NSAIDs. SPRIX should be discontinued immediately in patients with allergic reactions. (4, 5.5, 5.7, 5.11)
• Serious and potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. (5.6)
• Fluid retention and edema have been observed in patients taking NSAIDs. SPRIX should be used with caution in patients with cardiac decompensation or similar conditions. (5.4, 5.6)
• NSAIDs can cause serious dermatologic adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. SPRIX should be discontinued immediately in patients with skin reactions. (4, 5.7)
• During pregnancy, use of SPRIX beyond 30 weeks gestation can cause premature closure of the ductus arteriosus, resulting in fetal harm. (5.8)

The most common adverse reactions (incidence > 2%) in patients treated with SPRIX and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis. (6.1)