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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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Opioids: The Risk-Benefit Ratio

Prescriptions for opioid analgesics are proliferating–as are problems associated with them. Opioids have their place in appropriate pain management, but separating good use from misuse is crucial.

Opioid features

Between 1991 and 2009, US prescriptions for opioid analgesics increased almost threefold, to over 200 million.1 Approximately 90% of patients with chronic pain, for instance, receive opioids.2 And opioid analgesics are a mainstay of acute pain treatment.2

Opioids rank high in pain relief for many reasons, among them:

Effectiveness

  • µ-agonist opioids in particular are considered the “go to” analgesics for short-term treatment of moderate to severe pain3
  • They have no “ceiling effect”, so the dose can be increased until analgesia is achieved, or until side effects, such as respiratory depression, become unmanageable3
  • They mimic the actions of endogenous opioids, such as the neurotransmitters endorphins and enkaphalins4
  • They can be combined with nonopioid analgesics for added efficacy4

Flexibility

  • Opioids are available in short- and long-acting forms4
  • They can be administered via a variety of routes including oral, transdermal, injection, and intranasal4

Opioid drawbacks

Although many studies have shown that when properly managed, short-term medical use of opioid analgesics is safe and rarely causes addiction,5 opioids come with other drawbacks, both for the individual and for society.

Most of the drawbacks have to do with adverse reactions ranging from constipation to dependence.

Personal disadvantages

  • The short- and long-term impact of gastrointestinal adverse effects (such as constipation and nausea) and central nervous system adverse effects (such as sedation)2
    • Opioid-related mental impairment can lead to unintentional injuries
      such as falls and fractures among the elderly6
    • Use of opioids can raise the risk of motor vehicle accidents7
  • Risks of addiction, misuse, abuse, and diversion6

Societal disadvantages

The Centers for Disease Control and Prevention has called the abuse of prescription opioids an “epidemic” and the “fastest growing drug problem in America.” 6 Between 1999 and 2007, the number of unintentional overdose deaths involving opioid analgesics jumped by 296%—from 2,901 to 11,499.6

Unintentional Overdose Deaths Involving Opioid Analgesics (United States, 1997-2007)6

Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales in the US, chart Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales in the US, chart National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS System. Adapted from the US Centers for Disease Control and Prevention. Public Health Grand Rounds. Prescription drug overdoses: an American epidemic.

National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS System. Adapted from the US Centers for Disease Control and Prevention. Public Health Grand Rounds. Prescription drug overdoses: an American epidemic.

For every overdose death due to opioid analgesics, the problem is multiplied by other incidents that burden the public health system.6

  • 9 opioid abuse admissions for every death
  • 35 emergency department visits
  • 161 people with abuse/dependence issues
  • 461 nonmedical users of opioids

The challenges surrounding opioid misuse and their potential solutions are presented as part of the online Public Grand Round series hosted by the Centers for Disease Control and Prevention.

Prescription Drug Overdoses: An American Epidemic

Case Example: Utah had an alarmingly high rate of nonmedical use of pain relievers. See what steps were taken to assess the problem of opioid misuse and the ensuing response.

SPRIX® (ketorolac tromethamine) Nasal Spray is the first and only intranasal NSAID. It is indicated for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Continue the discussion An increase in opioid abuse How SPRIX® (ketorolac tromethamine) Nasal Spray may help
Data From the Clinical Studies Quick-view summaries of methodology, key findings, and more
SPRIX®–
A Non-narcotic Option DEA paperwork not required

REFERENCES:

  • US Department of Health and Human Services. National Institute on Drug Abuse. Analysis of opioid prescription practices finds areas of concern [news release]. April 5, 2011. http://www.nih.gov/news/health/apr2011/nida-05.htm. Accessed August 16, 2011.
  • Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician. 2008;11(2 Suppl):S105-120.
  • McCarberg BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther. 2001;8(3):181-186.
  • American Pain Society. Pain: Current Understanding of Assessment, Management, and Treatments. http://pain-topics.org/pdf/Pain_APS_2006.pdf. Accessed February 27, 2011.
  • National Institute of Drug Abuse. Prescription drugs abuse and addiction. http://www.nida.nih.gov/PDF/RRPrescription.pdf. Updated August 2005. Accessed August 16, 2011.
  • Centers for Disease Control and Prevention. Public Health Grand Rounds. Prescription drug overdoses: an American epidemic. http://www.cdc.gov/about/grand-rounds/archives/2011/01-February.htm#presentation. Accessed February 17, 2011.
  • National Highway Traffic Safety Administration. Drugged driving expert panel report: a consensus protocol for assessing the potential of drugs to impair driving. http://www.nhtsa.gov/staticfiles/nti/pdf/811438.pdf. Updated March 2011. 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.

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