Ketorolac trometamol

CLINICAL USE

Short-term management of moderate to severe acute postoperative pain

DOSE IN NORMAL RENAL FUNCTION

Oral: 10 mg every 4–6 hours (elderly every 6–8 hours); maximum 40 mg daily; maximum duration 7 daysIM/IV: initially 10 mg, then 10–30 mg when required every 4–6 hours (every 2 hours in initial postoperative period); maximum 90 mg daily (elderly and patients less than 50 kg: maximum 60 mg daily); maximum duration 2 days

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :376.4

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :>99

%Excreted unchanged in urine &nbsp &nbsp : Approx 60

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :0.15

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :IM dose: 3.5–9.2/5.9–19.2

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 &nbsp &nbsp : Maximum 60 mg daily

10 to 20 &nbsp &nbsp : Avoid if possible. Use small doses and monitor closely

<10 &nbsp &nbsp &nbsp &nbsp &nbsp : Avoid if possible. Use small doses and monitor closely

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Unlikely to be dialysed. Dose as in GFR <10 mL/min

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Unlikely to be dialysed. Dose as in GFR <10 mL/min

HDF/high flux &nbsp :Unknown dialysability. Dose as in GFR <10 mL/min

CAV/VVHD &nbsp &nbsp &nbsp:Unknown dialysability. Dose as in GFR 10 to 20 mL/min

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugsACE inhibitors and angiotensin-II antagonists: antagonism of hypotensive effect; increased risk of nephrotoxicity and hyperkalaemia

Analgesics: avoid concomitant use of 2 or more NSAIDs, including aspirin (increased risk of side effects and haemorrhage)

Antibacterials: possibly increased risk of convulsions with quinolonesAnticoagulants increased risk of bleeding with heparins, phenindione and coumarins – avoid concomitant use; increased risk of haemorrhage with parenteral ketorolac and heparin – avoid concomitant use

Antidepressants: increased risk of bleeding with SSRIs and venlaflaxineAntidiabetics: effects of sulphonylureas possibly enhanced

Anti-epileptics: effect of phenytoin possibly enhanced

Antivirals: increased risk of haematological toxicity with zidovudine: concentration possibly increased by ritonavir

Ciclosporin: increased risk of nephrotoxicityCytotoxics: excretion of methotrexate reduced; increased risk of bleeding with erlotinib

Diuretics: increased risk of nephrotoxicity; antagonism of diuretic effect; hyperkalaemia with potassium-sparing diuretics

Lithium: excretion of lithium reduced – avoid concomitant usePentoxifylline: risk of ketorolac associated bleeding increased– avoid concomitant useProbenecid: delays excretion of ketorolac – avoid concomitant use

Tacrolimus: increased risk of nephrotoxicity

ADMINISTRATION

Reconstition

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Route

IM, IV, oral

Rate of Administration

IV bolus over no less than 15 seconds

Comments

Compatible with sodium chloride 0.9%, glucose 5%, Ringers, lactated Ringers or plasmalyte solutionsKetorolac trometamol.KEToroLAC TroMETAMoL 411

OTHER INFORMATION

Drugs that inhibit prostaglandin biosynthesis (including NSAIDs) have been reported to cause nephrotoxicity, including, but not limited to, glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. In patients with renal, cardiac or hepatic impairment, caution is required since the use of NSAIDs may result in deterioration of renal functionKetorolac and its metabolites are excreted primarily by the kidneyReported renal side effects include increased urinary frequency, oliguria, acute renal failure, hyponatraemia, hyperkalaemia, haemolytic uraemic syndrome, flank pain (with or without haematuria), raised serum urea and creatinine.

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