Indications and Usage
SPRIX® is a nonsteroidal anti-inflammatory drug (NSAID) 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.
Limitations of Use
The total duration of use of SPRIX alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses. Do not use SPRIX concomitantly with other formulations of ketorolac or other NSAIDs. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX.
SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
IMPORTANT SAFETY INFORMATION - HCP
Important Safety Information
WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK
Limitations of Use
SPRIX®(ketorolac tromethamine) Nasal Spray, 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.
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.
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.
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.
SPRIX® Nasal Spray is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
SPRIX® is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
SPRIX® (ketorolac tromethamine) Nasal Spray is also contraindicated:
- in patients with known hypersensitivity or history of asthma, urticaria, or other allergic-type reactions to aspirin, ketorolac, other NSAIDs or ethylenediaminetetraacetic acid (EDTA)
- as a prophylactic analgesic prior to major surgery
- in labor and delivery
- in patients taking probenecid or pentoxifylline
Additional Warnings and Precautions:
- SPRIX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs.
- Gastrointestinal (GI) Effects: Risk of Ulceration, Bleeding, and Perforation: Ketorolac can cause serious GI adverse events including bleeding, ulceration, and perforation, which can be fatal. Elderly patients are at increased risk for serious GI events. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration.
- Hematological Effects: 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.
- Renal Effects: 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. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury such as interstitial nephritis and nephrotic syndrome.
- Anaphylactoid Reactions: 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.
- Cardiovascular (CV) Effects: CV Thrombotic Events, Hypertension, Congestive Heart Failure (CHF), and Edema: Serious and potentially fatal CV thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. NSAIDs can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response when taking NSAIDs. Fluid retention, edema, retention of NaCl, oliguria, and elevations of serum urea nitrogen and creatinine have been reported in clinical trials of ketorolac. SPRIX® should be used with caution in patients with cardiac decompensation or similar conditions.
- Skin Reactions: NSAIDs, including ketorolac, can cause serious dermatologic adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. These serious events may occur without warning. SPRIX® should be discontinued immediately with skin reactions or other signs of hypersensitivity.
- Pregnancy: Starting at 30 weeks gestation, SPRIX® can cause fetal harm when administered to a pregnant woman due to an increased risk of premature closure of the ductus arteriosus. If SPRIX® is used at or after 30 weeks gestation, the patient should be apprised of the potential hazard to a fetus.
- Hepatic Effects: Use SPRIX® with caution in patients with impaired hepatic function or history of liver disease.
- Inflammation and Fever: The pharmacologic activity of SPRIX® in reducing inflammation and fever may diminish the utility of these diagnostic signs in detecting infections.
- Preexisting Asthma: Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Do not administer SPRIX® to patients with this form of aspirin sensitivity, and use with caution in patients with preexisting asthma.
- Eye Exposure: Avoid contact of SPRIX® with the eyes. If eye contact occurs, wash out the eye with water or saline, and consult a physician if irritation persists for more than an hour.
Additional Drug Interactions:
- Aspirin: Concomitant administration of SPRIX® and aspirin is not generally recommended because of the potential for increased adverse effects.
- Anticoagulants: Concomitant use with anticoagulants may increase the risk of serious GI bleeding.
Most Common Adverse Reactions:
The most common adverse reactions (incidence >2%) in patients treated with SPRIX® and occurring at a rate at least twice that with placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis.
Please see Important Safety Information and complete Prescribing Information, including Boxed Warning, at www.sprix.com.