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Ketorolac Tromethamine Nasal Spray (Sprix)
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationship to this field of study.
FDA has approved a nonsteroidal anti-inflammatory drug (NSAID) formulated as a nasal spray for the treatment of pain. Ketorolac nasal spray is marketed by Roxro Pharma as Sprix.
Ketorolac nasal spray is indicated for the management of moderate to moderately severe pain that requires analgesia at the opioid level.1 It is indicated for short-term use only (up to 5 days).
The recommended dose in adults is one spray in each nostril every 6-8 hours. The maximum daily dose is 4 doses. For adults 65 years and older, those with renal impairment, and patients weighing less than 110 lbs, the recommended dose is one spray in one nostril every 6-8 hours with a maximum of 4 sprays per day.
Ketorolac nasal spray is supplied as a 1.7 g bottle containing 8 sprays. Each spray contains 15.75 mg of ketorolac tromethamine.
Intranasal ketorolac is absorbed through the nasal mucosa and achieves peak blood levels as fast as IM injections, while reducing opioid (morphine sulfate) use by 36%-26% compared to placebo.1,2 The product offers a non-opioid, non-injectable option for ambulatory pain control.
Nasal irritation was the most common adverse event (24% vs 2% for placebo).2 Ketorolac is an NSAID and, thus, is associated with peptic ulcers and gastrointestinal bleeding. It should be avoided in patients with peptic ulcer disease or history of GI bleeding. The drug also inhibits platelet function and is contraindicated in patients with cerebrovascular bleeding, hemorrhagic diatheses, incomplete hemostasis, or high risk of bleeding. Intranasal ketorolac is contraindicated in patients with advanced renal impairment or risk for renal failure.
Intranasal ketorolac is a new delivery system. The pharmacokinetics are similar to that of IM administration, but with about 60% the bioavailability.1,3 The efficacy of ketorolac nasal spray was evaluated in two, randomized, double-blind, placebo-controlled studies in patients with postoperative pain who had undergone elective abdominal surgery or orthopedic surgery.1 Study participants were randomized to placebo or ketorolac every 8 hours in one study (n = 300) and every 6 hours in the second study (n = 321). Efficacy was based on summed pain intensity difference between ketorolac and placebo over 48 hours. Ketorolac was significantly better than placebo. In addition, morphine use was reduced by 36% and 26%, respectively. In a single-dose study the summed pain intensity difference scores at 6 hours were 83.3 for ketorolac compared to 37.2 for placebo (P < 0.007).2 Post-hoc analysis suggests a greater summed pain intensity difference between ketorolac and placebo in participants who underwent orthopedic procedures (79.3 vs 24.9) compared to abdominal procedure (86.9 vs 48.2). Nasal irritation was more common with ketorolac (24%) compared to placebo (2%).2
Intranasal ketorolac provides an alternative delivery of the drug for short-term management of moderate to moderately severe pain.
1. Sprix Product Information. Menlo Park, CA: Roxro Pharma Inc.; May 2010.
2. Brown C, et al. Intranasal ketorolac for postoperative pain: A phase 3, double-blind, randomized study. Pain Med 2009;10:1106-1114.
3. McAleer SD, et al. Pharmacokinetics and safety of ketorolac following single intranasal and intramuscular administration in healthy volunteers. J Clin Pharmacol 2007;47:13-18.