Australian public assessment for Ibuprofen - Therapeutic Goods ...

AusPAR Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1
Final 2 January 2013
Therapeutic Goods Administration
However, there was no evidence of a dose-response relationship in the critically ill, so
increasing the dose beyond 400 mg q4h may not lead to an improvement in efficacy.
• A 6 h dose interval was not tested in critically ill patients. Lower ibuprofen
concentrations and efficacy in the critically ill mean that extension of the dose interval
to 6 h in such patients might not provide satisfactory pain relief over the entire dose
interval. While this might in theory be countered by increasing the dose to 800 mg,
neither the efficacy nor the safety of that approach were tested.
Medium to long-term efficacy in the treatment of fever was not studied.
Efficacy in children and adolescents (28 h (008C). CPI-CL-008A enrolled men
and women undergoing orthopaedic, abdominal or gynaecological surgery; 008B enrolled
women undergoing abdominal hysterectomy; 008C enrolled men and women undergoing
elective hip or knee replacement, reconstruction or arthroplasty.
Some exclusion criteria removed potential confounders, such as: the use of use of pre- or
intra-operative nerve or epidural 15 blocks; the use of NSAIDs during the 12 h before the
first dose of study medication; and the use of other analgesics during the 24 h (008A and
B) or 12 h (008C) before the first dose of study medication (with the exception of
paracetamol, which was allowed until 6 h pre-operatively and tramadol, which was
allowed up to midnight on the evening prior to surgery). Other exclusion criteria reflected
the standard precautions and contraindications for ibuprofen, or administrative matters
(such as unwillingness to comply with study procedures).
15 This exclusion is also safety-related.
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