Indications and Usage
SPRIX® (ketorolac tromethamine) 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.
Limitations of Use
- Sprix is not for use in pediatric patients less than 2 years of age.
IMPORTANT SAFETY INFORMATION ABOUT SPRIX
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- SPRIX® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Use SPRIX at the lowest effective dosage for shortest duration consistent with individual patient treatment goals.
SPRIX is contraindicated in the following patients:
- Known hypersensitivity to ketorolac or any components of the drug product.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
- In the setting of coronary artery bypass graft (CABG) surgery.
- Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
- Use as a prophylactic analgesic before any major surgery.
- Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
- Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
- Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
- Concomitant use with probenecid or pentoxifylline.
Warnings and Precautions
Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Hypertension: NSAIDs, including SPRIX, can lead to new onset or worsening of preexisting hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of SPRIX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If SPRIX is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury and may cause a dose-dependent reduction in prostaglandin formation, which may precipitate overt renal decompensation. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SPRIX in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity: SPRIX is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).
Serious Skin Reactions: NSAIDs, including SPRIX, can cause serious skin adverse reactions, which can be fatal. These serious events may occur without warning. Discontinue SPRIX at the first appearance of skin rash or any other sign of hypersensitivity.
Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.
Hematologic Toxicity: Anemia has occurred in patients treated with NSAIDs. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Do not use SPRIX in patients for whom hemostasis is critical.
Limitations of Use: The total duration of use of SPRIX alone or sequentially with other forms of ketorolac is not to exceed 5 days. SPRIX should not be used concomitantly with other forms of ketorolac, aspirin, or other NSAIDs.
The most common adverse reactions (incidence ≥2%) in patients treated with SPRIX and occurring at a rate at least twice that with placebo include: nasal discomfort; rhinalgia; increased lacrimation; throat irritation; oliguria; rash; bradycardia; decreased urine output; increased ALT and/or AST; hypertension; rhinitis.
Drugs that interfere with hemostasis: increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is contraindicated. Monitor patients for bleeding who are concomitantly taking SPRIX with drugs that interfere with hemostasis.
ACE inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers: may diminish the antihypertensive effect of these drugs; monitor blood pressure.
ACE Inhibitors and ARBs: In elderly, volume depleted, or those with renal impairment may result in deterioration of renal function; monitor for signs of worsening renal function.
Diuretics: reduces the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. During concomitant use of SPRIX with diuretics look for signs of worsening renal function and assure diuretic efficacy and antihypertensive effects.
Digoxin: has been reported to increase the serum concentration and prolong the half-life of digoxin, monitor serum digoxin levels.
Use in Specific Populations
Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SPRIX in women who have difficulties conceiving.
Please see Full Prescribing Information, including BOXED WARNING and MEDICATION GUIDE.
To report SUSPECTED ADVERSE REACTIONS, contact Egalet US Inc. at 1-800-518-1084 or FDA at 1-800-FDA-1088 or ww.fda.gov/medwatch.