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Important Safety Information |Prescribing Information
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 EDTA
  • in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates
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RESEARCH IN PRACTICE

AT A GLANCE

  • Morphine use over 48 hours decreased 26% in the ketorolac group compared with placebo1
  • While SPRIX® (ketorolac tromethamine) Nasal Spray was assessed in an inpatient, surgical setting in this study, it may have more relevance for use in outpatient settings and ambulatory surgery or fast-track surgical procedures1

Singla N, Singla S, Minkowitz HS, Moodie JE, Brown CR. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010;26(8):1915-1923.

SPRIX® provided significantly greater pain reduction vs placebo in a study of post-abdominal surgery patients, chart SPRIX® provided significantly greater pain reduction vs placebo in a study of post-abdominal surgery patients, chart The predose pain intensity score, as measured by the Visual Analog Scale (VAS), was 60.8 in the placebo group and 62.5 in the SPRIX® group. Pain intensity difference refers to the change with respect to the predose pain intensity value. Morphine use reduction was a secondary endpoint.3

The predose pain intensity score, as measured by the Visual Analog Scale (VAS), was 60.8 in the placebo group and 62.5 in the SPRIX® group. Pain intensity difference refers to the change with respect to the predose pain intensity value. Morphine use reduction was a secondary endpoint.3

Intranasal ketorolac has been evaluated in placebo-controlled studies in patients following major surgery with both single and multiple doses in combination with opioid analgesia and dental impaction surgery following a single dose. Patients who received 31.5 mg IN ketorolac in single or multiple doses had significant reductions in mean morphine sulfate use, significantly lower pain intensity scores, and superior quality of analgesia ratings compared with placebo. Single and multiple doses of intranasal ketorolac were well tolerated in this study. IN ketorolac use is also associated with a reduction in the incidence of side effects typically observed following opioid use, including pruritus, pyrexia, and constipation.

Phase 3, randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and tolerability of IN ketorolac use after abdominal surgery in patients permitted to use opioid analgesia.

  • Adult patients were randomly assigned to receive ketorolac 31.5 mg (n=214) or placebo (n=107) every 6 hours after surgery for 48 hours, then up to 4 times/day for up to 5 days
  • After surgery, intravenous (IV) opioid was administered until patients were comfortable
  • Patients recorded pain intensity (PI) ratings using a 100-mm visual analog scale; when PI ratings equaled at least 40, patients received IN ketorolac or placebo
  • Morphine sulfate via patient-controlled analgesia was available in both groups as needed
  • 6-hour summed pain intensity difference (SPID) scores were significantly greater in the ketorolac group, indicating better analgesic efficacy compared with placebo (117.4 vs 89.9, [P = 0.032], difference 27.6)1
  • Morphine use over 48 hours decreased 26% in the ketorolac group compared with placebo1
  • Day 1 global pain control scores were significantly better in the ketorolac group compared with placebo1
  • Adverse events were similar in both groups; rhinalgia and nasal irritation, generally mild and transient, were more common in the ketorolac group1
  • There was a trend for reduced incidences of nausea and constipation in the ketorolac group compared with placebo; the lower rates of those and other opioid-related side effects likely reflect the decreased morphine use1

IN delivery of ketorolac achieved peak plasma concentrations with similar kinetics as intramuscular injection in a formulation that patients can self-administer. This may have utility in ambulatory patients, and can provide continuity of pain management as patients transition to home.

As an alternative to ketorolac injection, IN ketorolac could help achieve recommended recovery goals for ambulatory and fast-track surgery patients.

Continue the discussion Pain relief after oral surgery Pain relief after abdominal and orthopedic surgery
A Case Study in Utah One state’s response to opioid misuse
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REFERENCES:

  • Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010;26(8):1915-1923.
  • Levin RA. Clinical Review of NDA22.382. FDA Center for Drug Evaluation and Research. October 5, 2009.
  • Brown C, Moodie J, Bisley E, Bynum L. Intranasal ketorolac for postoperative pain: A phase 3, double-blind, randomized study. Pain Med. 2009;10(6):1106-1114.
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.

Gastrointestinal Risk
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.

Bleeding Risk
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.

Cardiovascular Risk
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® is contraindicated for treatment of perioperative 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® (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 EDTA
  • in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates
  • as a prophylactic analgesic prior to major surgery
  • in labor and delivery

Additional Warnings and Precautions:

  • SPRIX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs, or with probenecid or pentoxifylline.

  • Risk of GI Ulceration, Bleeding, and Perforation: Ketorolac can cause serious adverse events including bleeding, ulceration, and perforation which can be fatal. Elderly patients are at increased risk for serious GI events. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX® alone or sequentially with other forms of ketorolac.

  • 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.

  • CV Effects: CV Thrombotic Events, Hypertension, Congestive Heart Failure (CHF) and Edema: 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 hypersensitvity.

  • Pregnancy: During pregnancy, use of SPRIX® beyond 30 weeks gestation can cause premature closure of the ductus arteriosus, resulting in fetal harm (Pregnancy Category D). Prior to 30 weeks gestation, SPRIX® should be used during pregnancy only if potential benefit justifies the potential risk to the fetus (Pregnancy Category C).

  • 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.

  • 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: Protein binding is reduced when ketorolac is administered with aspirin although the clearance of free ketorolac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of SPRIX® and aspirin is not generally recommended because of the potential of increased adverse effects.

  • Diuretics: Ketorolac can reduce the natriuretic effect of furosemide and thiazides in some patients.

  • ACE Inhibitors/Angiotensin II Receptor Antagonists: Concomitant use of ACE inhibitors and/or angiotensin II receptor antagonists may increase the risk of renal impairment, particularly in volume-depleted patients. NSAIDs may diminish the antihypertensive effect of ACE inhibitors and/or angiotensin II receptor antagonists. Consider this interaction in patients taking SPRIX® concomitantly with ACE inhibitors and/or angiotensin II receptor antagonists.

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 of 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.

Regency Therapeutics Osteohealth Distributed by American Regent, Inc. © 2013 Luitpold Pharmaceuticals, Inc.
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