In clinical studies, SPRIX® (ketorolac tromethamine) Nasal Spray has been well tolerated—nasal discomfort and irritation were the most common side effects.1 Nasal irritation is generally mild and transient (lasting less than 5 minutes) and did not worsen with repeated administration.2 In controlled efficacy trials, 6.5% of patients treated with SPRIX® and 2.4% of patients treated with placebo discontinued due to nasal irritation.3
Details on adverse reactions, contraindications, limitations of use and other safety-related information are provided in the Important Safety Information and Prescribing Information.
In clinical studies, 1.5% of patients treated with SPRIX® experienced serious adverse events of bleeding or hematoma at the operative site, vs 0.4% treated with placebo.4
SPRIX® is contraindicated with known hypersensitivity to ketorolac tromethamine, ethylenediamine tetraacetic acid, aspirin or to other NSAIDs and use in patients with a history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs.
SPRIX® is also contraindicated as a prophylactic analgesic before any major surgery and in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
Use with allergy medicines
SPRIX® can be prescribed for patients being treated for allergies with nasal medications. It has been studied in patients with allergic rhinitis before and after administration of fluticasone and oxymetazoline. Neither allergy medicine had any clinically significant effect on the pharmacokinetic characteristics of SPRIX®.1
SPRIX® is absorbed through the nasal mucosa, bypassing the GI tract. It is a useful option for patients struggling with nausea and vomiting, particularly postoperative patients.
Moreover, placebo-controlled studies have shown a trend for a reduced incidence of nausea and constipation in patients taking intranasal ketorolac and other parenteral formulations of ketorolac, likely reflecting decreased morphine use.2,4
Ketorolac tromethamine, including SPRIX®, can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, SPRIX® 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. Elderly patients are at greater risk for serious gastrointestinal events.
The incidence of gastrointestinal hemorrhage with ketorolac is similar to that seen with morphine, unless use is extended beyond 5 days, or patients are at high risk for complications.2
In controlled clinical trials in patients who have undergone major surgery (primarily knee and hip replacements and abdominal hysterectomies), 7 patients (n=455, 1.5%) treated with SPRIX® experienced serious adverse events of bleeding (4 patients) or hematoma (3 patients) at the operative site, vs one placebo patient (n=245, 0.4%) who developed hematoma.1
Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding.