LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL
Limitations of Use
SPRIX (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug (NSAID),
is indicated for short-term (up to 5 days in adults) management of moderate
to moderately severe pain that requires analgesia at the opioid level. Do not
exceed a total combined duration of use of SPRIX and other ketorolac formulations
(IM/IV or oral) of 5 days [see DOSAGE AND ADMINISTRATION, and WARNINGS
SPRIX is not indicated for use in pediatric patients and it is not indicated
for minor or chronic painful conditions.
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 [see
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
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
[see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk [see WARNINGS AND PRECAUTIONS].
SPRIX Nasal spray is contraindicated for treatment of peri-operative
pain in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS].
SPRIX is contraindicated in patients with advanced renal impairment
and in patients at risk for renal failure due to volume depletion [see CONTRAINDICATIONS,
WARNINGS AND PRECAUTIONS].