Intravenous ibuprofen: the first injectable product for the treatment of pain and fever

Figures & data

Table 1 Summary of pharmacokinetic parameters of intravenous ibuprofen

Parameter	100 mg dose	200 mg dose	400 mg dose	800 mg dose
Study: Morris et al^Citation33
Number of patients	31	30	31	_
AUC (μg.h/mL)	22.33 (12.75)	32.62 (17.39)	70.64 (31.93)	–
Cmax (μg/mL)	12.17 (6.78)	18.93 (10.50)	39.76 (17.75)	–
T1/2 (h)	2.47 (1.15)	2.11 (1.05)	2.26 (0.95)	–
Study: Intravenous ibuprofen product labeling; Data on file with Cumberland Pharmaceuticals^®^Citation25,Citation34
Number of patients	–	–	12	12
AUC (μg.h/mL)	–	–	109.3 (26.4)	192.8 (18.5)
Cmax (μg/mL)	–	–	39.2 (15.5)	72.6 (13.2)
T1/2 (h)	–	–	2.22 (20.1)	2.44 (12.9)
Study: Pavliv et al^Citation34
Number of patients	–	–	–	12
AUC (μg.h/mL)	–	–	–	195.7 (37.3)
Cmax (μg/mL)	–	–	–	120.3 (13.5)
T1/2 (h)	–	–	–	2.0 (0.5)

Table 2 Summary of intravenous ibuprofen clinical studies

Author	Study aim	Treatment arm	Results
Kroll et al^Citation49	Efficacy and safety in adult abdominal surgery patients (N = 319)	800 mg IV or placebo every 6 hours + PRN morphine	Efficacy: morphine requirements in ibuprofen group 43.7 mg and placebo 56 mg (P < 0.001) Safety: no differences in adverse events
NCT00606489, Cumberland Pharmaceuticals, Inc.^Citation56	Efficacy (fever and pain) and safety in pediatric and adult burn patients (N = 61)	800 mg IV or placebo every 6 hours during 120-hour treatment period	Efficacy: significant reduction in fever in 800 mg ibuprofen versus placebo in first 24 hours as measured by AUC-T (P = 0.03) Safety: no significant difference between the two groups for adverse events; no differences between the groups for laboratory values, frequency of blood transfusions, or bleeding
Morris et al^Citation33	Efficacy (fever) and safety in hospitalized adult patients (N = 120; ∼33% were critically illa)	100 mg, 200 mg, 400 mg IV or placebo every 4 hours for a total of 6 doses	Efficacy: proportion of patients <38.3°C at 4 hours post initial dose: placebo (32%), 100 mg (61%), 200 mg (70%), 400 mg (77%) (P < 0.05 for all treatment arms versus placebo) Safety: no statistical significant differences in serious adverse events between treatment arms through study day 28
NCT00470600, Cumberland Pharmaceuticals, Inc.^Citation50	Efficacy and safety in hospitalized adult orthopedic surgery patients (N = 185)	800 mg IV or placebo every 6 hours + PRN morphine	Efficacy: morphine requirements reduced by 30.9% compared to placebo (P < 0.001); reduction of 20%–32% in mean VAS-AUC (at movement and rest) and VRS; Safety: significant increase in vomiting in the treatment arm versus placebo
Southworth et al^Citation3	Efficacy and safety in adult abdominal (73%) or orthopedic surgery patients (27%) (N = 406)	400 mg, 800 mg IV or placebo every 6 hours for 8 doses + morphine PCA	Efficacy: morphine requirements reduced by 22% in the 800 mg arm (P = 0.03), 3% in the 400 mg arm (P = NS) versus placebo; 800 mg arm resulted in significant reductions in pain earlier than 400 mg arm when compared to placebo (1–6 hours versus 6–12 hours) Safety: no significant differences in serious adverse events between treatment arms through study day 14

a Critically ill defined as mechanical ventilation and/or requiring vasopressor support.

Abbreviations: IV, intravenous; PRN, as needed; AUC-T, area under the temperature curve; VAS, visual analog scale; VRS, verbal response scale; PCA, patient-controlled analgesia.

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Cadolor [package insert]Nashville, TNCumberland Pharmaceuticals2009

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PavlivLRA randomized, double-blind, placebo-controlled, single dose, crossover study of the pharmacokinetics, safety and tolerability of ibuprofen injection in healthy adult volunteersAmerican Society of Health System Pharmacists Midyear Clinical MeetingLas Vegas, NV2009

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KrollPMLRockAKaelinBPavlivLIntravenous ibuprofen for the management of postoperative pain in adultsAmerican Academy of Pain Management Annual MeetingPhoenix, AZ2009

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Cumberlond PharmaceuticalsNCT00606489, Efficacy (fever and pain) and safety of Caldolor in hospitalized burn patients; Data on File

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Cumberlond PharmaceuticalsNCT00470600, Efficacy and Safety Study of Caldolor in Hospitalized Adult Orthopedic Patients; Data on File

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SouthworthSPetersJRockAPavlivLA multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative painClin Ther2009311922193519843482

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