Sprix (ketorolac tromethamine)

Company
Roxro Pharma

Approval Status
Approved May 2010

Treatment for
moderate to severe pain

Areas
Neurology & Nervous System

Sprix is an intranasal formulation of Ketorolac, a non-steroidal anti inflammatory drug.

Sprix is specifically indicated for adults for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Sprix is supplied as a solution for intranasal inhalation. The total duration of use of Sprix alone or sequentially with other formulations of ketorolac must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses. The recommended initial dose of Sprix is as follows:
Adults < 65 Years of Age: 31.5 mg Sprix (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg (four doses).
Reduced Doses for Special Populations; For patients > 65 years of age, renally impaired patients, and adult patients less than 50 kg (110 lbs), the recommended dose is 15.75 mg Sprix (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg (four doses).

FDA Approval
The FDA approval of Sprix was based on two multi-center, randomized, double-blind, placebo controlled studies for post-operative pain.
Study One
This study enrolled 300 adults who had undergone elective abdominal or orthopedic surgery. The subjects received Sprix or placebo administered every 8 hours and morphine administered via patient controlled analgesia on an as needed basis. Efficacy was demonstrated as a statistically significant greater reduction in the summed pain intensity difference over 48 hours in patients who received Sprix as compared to those receiving placebo. The patients treated with Sprix required 36% less morphine over 48 hours than those treated with placebo.
Study Two
This study enrolled 321 subjects who had undergone elective abdominal surgery. The subjects received Sprix or placebo administered every 6 hours and morphine administered via patient controlled analgesia on an as needed basis. Efficacy was demonstrated as a statistically significant greater reduction in the summed pain intensity difference over 48 hours in patients who received Sprix as compared to those receiving placebo. The patients treated with Sprix required 26% less morphine over 48 hours than those treated with placebo.

Adverse events associated with the use of Sprix may include, but are not limited to, the following:

  • Nasal discomfort
  • Rhinalgia
  • Lacrimation increased
  • Throat irritation
  • Oliguria
  • Rash

Sprix is an intranasal formulation of the non-steroidal anti inflammatory drug Ketorolac. Ketorolac is an analgesic that inhibits the enzyme cylooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced synthesis of prostaglandins, thromboxanes, and prostacyclin.

For additional information regarding Sprix or moderate to severe pain, please visit the Sprix web page.

Sprix Drug Information

The Sprix drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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