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Generic Name: ketorolac tromethamine nasal spray
Date of Approval: May 14, 2010
Company: Roxro Pharma, Inc.
Treatment for: Pain
FDA Approves Sprix
The U.S. Food and Drug Administration (FDA) has approved Sprix (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.
Sprix is a prescription intranasal formulation of the analgesic ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute moderate to moderately severe pain relief.
Ketorolac tromethamine is a frequently administered non-narcotic injectable analgesic for moderately severe pain in U.S. hospitals today. The approval of Sprix provides acute pain outpatients with a non-narcotic and easy-to-administer alternative to commonly prescribed opioids.
Highlights of Sprix Prescribing Information
These highlights do not include all of the information needed to use Sprix safely and effectively. See full prescribing information for Sprix.
Warning: Limitations of Use, Gastrointestinal, Bleeding, Cardiovascular, and Renal Risk
See full prescribing information for complete boxed warning.
* Limitations of Use – The total duration of use of Sprix and other ketorolac formulations should not exceed 5 days.
* Gastrointestinal (GI) Risk – Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal.
* Sprix is contraindicated in patients with peptic ulcer disease or history of GI bleeding.
* Bleeding Risk – Sprix inhibits platelet function and is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding.
* Cardiovascular (CV) Risk – NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
* Sprix is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
* Renal risk – Sprix is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
Sprix Indications and Usage
Sprix is indicated for short term (up to 5 days) management of moderate to moderately severe pain.