Tranexamic Acid (ICU/Trauma/Surgical)

eMC §4.2 (Cyklokapron 100 mg/mL solution for injection/infusion, emc product 1077): '1. Standard treatment of local fibrinolysis: 0.5 g (1 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) two to three times daily. 2. Standard treatment of general fibrinolysis: 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent to 15 mg/kg body weight.' SCOPE WARNING — READ BEFORE USING THIS PAGE IN TRAUMA: the fetched §4.2 contains ONLY the two fibrinolysis regimens above. It does NOT contain any trauma or major-haemorrhage protocol, i.e. there is no loading-dose-plus-maintenance-infusion regimen of the kind used in trauma practice, no treatment time window from time of injury, and no cardiac-surgery regimen — indeed the SPC states that the efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established. The figures above must not be read as a trauma protocol; the clinician must source the trauma / major-haemorrhage regimen from the applicable national or local guideline and add it separately. RATE LIMIT IS MANDATORY: administration is strictly limited to slow intravenous injection or infusion of maximum 1 mL per minute; at the 100 mg/mL strength of this product, 1 g is 10 mL and therefore takes at least 10 minutes. Malaise with hypotension, with or without loss of consciousness, generally follows a too-fast intravenous injection. MEDICATION-ERROR SAFETY (§4.2/§4.4): to reduce the risk of fatal medication errors due to incorrect route of administration, it is strongly recommended to label the syringes containing tranexamic acid; serious adverse reactions including fatal events have been reported after inadvertent intrathecal administration, comprising severe back, gluteal and lower limb pain, myoclonus, generalised seizures and cardiac arrhythmias. CONVULSIONS (§4.4): cases have been reported in association with treatment; in coronary artery bypass graft surgery most were reported following intravenous injection of high doses, whereas at the recommended lower doses the incidence of post-operative seizures was the same as in untreated patients. VISUAL DISTURBANCES (§4.4): attention should be paid to possible visual disturbances and treatment discontinued if necessary; with continuous long-term use, regular ophthalmologic examinations are indicated. HAEMATURIA (§4.4): in haematuria from the upper urinary tract there is a risk of urinary obstruction at lower levels of the tract. ELDERLY: no reduction in dosage is necessary unless there is evidence of renal failure. HEPATIC IMPAIRMENT: no dose adjustment is required. PAEDIATRIC — HELD OUT OF THE STRUCTURED FIELD ON PURPOSE: §4.2 states 'In children from 1 year, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited.' That is a TOTAL DAILY dose and the SPC does not state how it is divided, so it cannot be published in the structured per-administration paedDose field without being rendered as the size of each dose; paedDose is therefore null. Verify all paediatric use against a children's formulary. Some sections of the product information we used were incomplete — check the full SPC. The bundle has since been re-fetched and now carries the correct UK intravenous SPC, from which this draft is taken; the withdrawn figures are deliberately not restated here, and no oral-route or dental-indication figure has been carried over.