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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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Tolerability

In clinical studies, SPRIX® (ketorolac tromethamine) Nasal Spray has been well tolerated—nasal discomfort and irritation were the most common side effects.1 Nasal irritation is generally mild and transient (lasting less than 5 minutes) and did not worsen with repeated administration.2 In controlled efficacy trials, 6.5% of patients treated with SPRIX® and 2.4% of patients treated with placebo discontinued due to nasal irritation.3

Details on adverse reactions, contraindications, limitations of use and other safety-related information are provided in the Important Safety Information and Prescribing Information.

Postoperative patients with adverse reactions observed at a rate of 2% or more and at least twice the incidence of the placebo group Postoperative patients with adverse reactions observed at a rate of 2% or more and at least twice the incidence of the placebo group In clinical studies, 1.5% of patients treated with SPRIX® experienced serious adverse events of bleeding or hematoma at the operative site, vs 0.4% treated with placebo.4

In clinical studies, 1.5% of patients treated with SPRIX® experienced serious adverse events of bleeding or hematoma at the operative site, vs 0.4% treated with placebo.4

SPRIX® is contraindicated with known hypersensitivity to ketorolac tromethamine, ethylenediamine tetraacetic acid, aspirin or to other NSAIDs and use in patients with a history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs.

SPRIX® is also contraindicated as a prophylactic analgesic before any major surgery and in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.

Use with allergy medicines

SPRIX® can be prescribed for patients being treated for allergies with nasal medications. It has been studied in patients with allergic rhinitis before and after administration of fluticasone and oxymetazoline. Neither allergy medicine had any clinically significant effect on the pharmacokinetic characteristics of SPRIX®.1

Gastrointestinal effects

SPRIX® is absorbed through the nasal mucosa, bypassing the GI tract. It is a useful option for patients struggling with nausea and vomiting, particularly postoperative patients.

Moreover, placebo-controlled studies have shown a trend for a reduced incidence of nausea and constipation in patients taking intranasal ketorolac and other parenteral formulations of ketorolac, likely reflecting decreased morphine use.2,4

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 risks

The incidence of gastrointestinal hemorrhage with ketorolac is similar to that seen with morphine, unless use is extended beyond 5 days, or patients are at high risk for complications.2

In controlled clinical trials in patients who have undergone major surgery (primarily knee and hip replacements and abdominal hysterectomies), 7 patients (n=455, 1.5%) treated with SPRIX® experienced serious adverse events of bleeding (4 patients) or hematoma (3 patients) at the operative site, vs one placebo patient (n=245, 0.4%) who developed hematoma.1

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.

Continue the discussion An option for patients with nausea and vomiting Review safety and pharmacokinetics data
Resources for Your Practice and Your Patients Obtain patient guides, details about clinical studies and other resources.
Patient Counseling Information Details about use, adverse events and other guidance

REFERENCES:

  • SPRIX® Prescribing Information. Shirley, NY: American Regent, Inc; 2011.
  • 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.
  • Data on file. Integrated summary of safety. Shirley, NY: Luitpold Pharmaceuticals, Inc.
  • 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.
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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