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
continue reading below...
Header

Case Example: Opioid Abuse and Misuse in Utah1

In 2005, Utah had the largest incidence of reported nonmedical use of pain relievers, along with an increase in prescription opioid-related deaths. Between 1999 and 2007, deaths in Utah attributed to poisoning by prescription pain medications increased nearly 600%, from 39 to 261. In 2008, the Utah Department of Health added 12 questions to the state’s Behavioral Risk Factor Surveillance System (BRFSS) survey to better understand how state residents obtain and use prescription pain medication.

A problem with prescriptions

The survey revealed causes and suggested possible approaches to reducing opioid-related problems. Some of the findings included1:

  • 20.8% of responding Utah adults aged ≥18 years had been prescribed an opioid pain medication during the preceding 12 months
  • Providers commonly prescribed more doses than were used by patients
  • Of patients prescribed an opioid pain medication:
    • 3.2% reported using their medication more frequently or in higher doses than had been directed by their doctor
    • 72% reported having leftover medication
    • 71% of those with leftover medication reported that they had kept the medication
  • 1.8% of all adults reported using prescription opioids that had not been prescribed to them
    • Pain relief was the most common reason reported for using prescription opioids not prescribed to the individual

Select Results From Utah Behavioral Risk Factor Surveillance System (BRFSS) Survey1

TABLE. Percentage of respondents aged ≥18 years who reported using a prescription opioid medication in the preceding 12 months, by reported medication-related behaviors — Behavioral Risk Factor Surveillance System, Utah, 2008
Behavior No.* % (95% CI§)
Used opioid pain medication prescribed to respondent by a doctor 5,330 20.8 (19.2–22.3)
For last prescription fill, used opioid medication more frequently or in higher doses than prescribed 1,058 3.2 (1.6–4.7)
For last opioid prescription fill, had leftover medication 1,058 72.0 (68.3–75.7)
What did respondent do with leftover medication? 751
Disposed of it 25.2 (21.0–29.5)
Gave it to someone else 2.3 (0.1–4.5)
Kept it 71.0 (66.4–75.6)
Other 1.5 (0.8–2.2)
For last opioid prescription fill, what type of pain
was the indicated treatment?
1,058
Short-term pain 71.0 (67.3–74.6)
Long-term pain 14.7 (12.2–17.2)
Both 14.4 (11.4–17.3)
Used opioid pain medications not prescribed to respondent 5,330 1.8 (1.4–2.3)
Reasons for using opioid pain medication not prescribed
to respondent (multiple responses permitted)
93
To relieve pain 72.4 (57.9–81.7)
For fun 15.3 (0.8–20.5)
To relieve anxiety 3.7 (0.6–5.5)
To relieve other physical symptom 2.2 (0–5.4)
Other 10.5 (9.5–29.2)
From whom did respondent obtain the opioid pain medication? 93
Friend or relative 97.0 (94.3–99.8)
Acquaintance 1.8 (0–4.3)
Other 1.2 (0–2.6)
How was the opioid pain medication obtained? 93
Given without charge 85.2 (73.3–97.2)
Took without knowledge or permission of owner 9.8 (0–20.7)
Purchased 4.1 (0–10.0)
Other 0.9 (0.4–1.4)
* Weighted by age, race, and sex to mirror the Utah adult population aged ≥18 years.
† Subgroup percentages might not add to 100.0% because of rounding.
§ Confidence interval.

Utah recommends…1

In 2009, the Utah Department of Health published guidelines to reduce the morbidity, mortality, and disability associated with misuse or abuse of prescription drugs, especially narcotics. The recommendations include:

  • Use opioid medications for acute or chronic pain only after determining that alternative therapies do not deliver adequate pain relief
  • Use the lowest effective dose
  • Prescribe no more than the number of doses needed, based on the usual duration of pain severe enough to require opioids for that condition
  • Reserve long-acting or sustained-release opioids for long-term pain
  • Counsel patients to dispose of unused medication properly once the pain has resolved
  • Seek specialty consultation if patients continue to experience severe pain without functional improvement despite treatment with opioids
  • Periodically request a report on the prescribing of opioids to their patients by other providers (such reports generally are available from the state prescription drug monitoring program)
How May We Assist? Receive more information or a call from a representative
EFFICACY AFTER MAJOR SURGERY Patients underwent hip/knee replacement and total hysterectomy.

REFERENCE:

  • Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. Adult Use of Prescription Opioid Pain Medications—Utah, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5906a1.htm. Accessed August 16, 2011.
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.