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Toradol Oral

Clinical Pharmacology
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Clinical Pharmacology

Type of Subjects Total Clearance [in L/h/kg]3 Terminal Half-life [in hours]
IM ORAL IM ORAL
Mean
(range)
Mean
(range)
Mean
(range)
Mean
(range)
Normal Subjects
IM (n=54)
mean age=32, range=18–60
Oral (n=77)
mean age=32, range=20–60
0.023
(0.010–0.046)
0.025
(0.013–0.050)
5.3
(3.5–9.2)
5.3m
(2.4–9.0)
Healthy Elderly Subjects
IM (n=13),
Oral (n=12)
mean age=72, range=65–78
0.019
(0.013–0.034)
0.024
(0.018–0.034)
7.0
(4.7–8.6)
6.1
(4.3–7.6)
Patients with Hepatic Dysfunction
IM and Oral (n=7)
mean age=51, range=43–64
0.029
(0.013–0.066)
0.033
(0.019–0.051)
5.4
(2.2–6.9)
4.5
(1.6–7.6)
Patients with Renal Impairment
IM (n=25), Oral (n=9) serum creatinine=1.9–5.0 mg/dL,
mean age (IM)=54, range=35–71
mean age (Oral)=57, range=39–70
0.015
(0.005–0.043)
0.016
(0.007–0.052)
10.3 (5.9–19.2) 10.8 (3.4–18.9)
Renal Dialysis Patients
IM and Oral (n=9) mean age=40, range=27–63
0.016
(0.003–0.036)
13.6
(8.0–39.1)
1Estimated from 30 mg single IM doses of ketorolac tromethamine
2Estimated from 10 mg single oral doses of ketorolac tromethamine
3Liters/hour/kilogram
IV Administration

In normal adult subjects (n=37), the total clearance of 30 mg IV-administered ketorolac tromethamine was 0.030 (0.017-0.051) L/h/kg. The terminal half-life was 5.6 (4.0-7.9) hours. (See Kinetics in Special Populations for use of IV dosing of ketorolac tromethamine in pediatric patients.)

Clinical studies

Adult Patients

In a postoperative study, where all patients received morphine by a PCA device, patients treated with ketorolac tromethamineIV as fixed intermittent boluses (e.g., 30 mg initial dose followed by 15 mg q3h), required significantly less morphine (26%) than the placebo group. Analgesia was significantly superior, at various postdosing pain assessment times, in the patients receiving ketorolac tromethamineIV plus PCA morphine as compared to patients receiving PCA-administered morphine alone.

Pediatric Patients

There are no data available to support the use of TORADOLORAL in pediatric patients.

Brand Name: Toradol Oral
Generic Name: Ketorolac Tromethamine
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