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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

  • A single intranasal (IN) ketorolac 31.5-mg dose was well tolerated and provided effective pain relief in oral surgery patients for up to 8 hours1
  • Median time to rescue medication for patients receiving SPRIX® (ketorolac tromethamine) Nasal Spray was significantly longer1

Grant GM, Mehlisch DR. Intranasal ketorolac for pain secondary to third molar impaction surgery: a randomized, double-blind, placebo-controlled trial. Oral Maxillofac Surg. 2010;68(5):1025-1031.

Global Assessment of Pain Control 8 Hours After a Single Dose in a Randomized, Double-Blind Placebo controlled Trial of Sprix® For Secondary to Third Molar Impaction Surgery Global Assessment of Pain Control 8 Hours After a Single Dose in a Randomized, Double-Blind Placebo controlled Trial of Sprix® For Secondary to Third Molar Impaction Surgery

Nonopioid analgesics are sometimes prescribed in ambulatory settings to speed recovery time and decrease opioid-related side effects. Compared with other pain-relief treatments after oral impaction surgery, ketorolac has been associated with a reduced incidence of drowsiness and nausea. Intranasal ketorolac is self-administered and may be considered an option to injectable ketorolac and opioids that may support continuity of pain management immediately after surgery and on an outpatient basis.

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IN ketorolac in patients who had third molar extraction surgery with bony impactions.

  • After surgery, patients were randomly assigned to receive IN ketorolac 31.5 mg (n=40) or IN placebo (n=40)
  • Safety was assessed from spontaneously reported adverse events and measurement of vital signs
  • Efficacy assessments included pain intensity, which was measured on a
    100-mm visual analog scale, total pain relief, and global pain evaluation
    up to 8 hours after dosing or until patients required rescue analgesia
  • The primary efficacy variable was the summed pain intensity difference score over the first 8 hours after dosing
  • Summed pain intensity difference (SPID) values ± SE were significantly higher (indicating better analgesia) in the ketorolac group compared with placebo (136.7 ± 33.0 vs -105.2 ± 29.1)1
  • Total pain relief scores were significantly higher in the ketorolac group compared with placebo at all times1
  • A larger proportion of subjects in the ketorolac group reported good, very good, or excellent pain control compared with the control group (60% vs 13%)1
  • Median time to rescue medication in SPRIX® patients was significantly longer (360 minutes vs 96 minutes with placebo [P<0.001])1
  • Eight patients in the placebo group and 3 in the ketorolac group had adverse events, none of which was serious1

IN ketorolac provides an alternative to injectable analgesics for ambulatory surgical patients, and may be especially valuable where oral medications are not practical. Because IN ketorolac can be self-administered, its use allows the same pain medication and dose to be used immediately after surgery and at home.

A single dose of IN ketorolac 31.5 mg was well tolerated and effectively managed postoperative pain in oral surgery patients for up to 8 hours.

Continue the discussion Pain relief after abdominal and orthopedic surgery Review safety and pharmacokinetics data
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REFERENCE:

  • Grant GM, Mehlisch DR. Intranasal ketorolac for pain secondary to third molar impaction surgery: a randomized, double-blind, placebo-controlled trial. J Oral Maxillofac Surg. 2010;68(5):1025-1031.
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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