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Comparison of the Pharmacokinetics of Ketorolac Tromethamine After Continuous Subcutaneous Infusion and Repeat Intramuscular Bolus Injections in Healthy Adult Subjects
Author(s) -
Burdick Michael,
Mamelok Richard,
Hurliman Michele,
Dupuis Mariève,
Xie Yuli,
Grenier Julie,
Sheldon Curtis,
Gartner Michael,
Noymer Peter
Publication year - 2017
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.319
Subject(s) - medicine , ketorolac tromethamine , pharmacokinetics , anesthesia , bolus (digestion) , cmax , crossover study , intramuscular injection , ketorolac , bioavailability , regimen , analgesic , pharmacology , surgery , placebo , alternative medicine , pathology
Ketorolac tromethamine is a nonsteroidal anti‐inflammatory drug that exhibits analgesic activity with no sedative or anxiolytic properties. Twelve healthy male subjects were enrolled in a study to receive either of 2 treatments over 2 periods in an open‐label, randomized, 2‐way crossover design: (A) 120 mg of ketorolac tromethamine administered as a continuous subcutaneous infusion over a 24‐hour period; or (B) an identical total daily dose administered as 4 intramuscular bolus injections of 30 mg each given every 6 hours (current labeled treatment regimen). The pharmacokinetic and safety profiles were evaluated for both treatments. Both modes of administration have similar values for area under the curve (AUC) and half‐life (t 1/2 ), suggesting that continuous subcutaneous infusion and repeated intramuscular bolus injections have similar bioavailability. The peak plasma concentration (C max ) was 40% lower when ketorolac was administered as a continuous subcutaneous infusion compared with repeat intramuscular bolus injections. The concentration at steady‐state (C ss ) for continuous subcutaneous infusion was between the C max and C trough values obtained following the 4 intramuscular injections. Both treatment arms were well tolerated.