Tranexamic Acid 1g IV

SCOPE — READ FIRST: the source is the IV Cyklokapron SPC, and what it doses is 'local fibrinolysis' and 'general fibrinolysis'. It contains NO trauma (CRASH-2) protocol, NO arthroplasty- or induction-specific regimen, and NO topical / intra-articular regimen — so the at-induction-plus-post-operative-infusion regimen and the topical intra-articular regimen shown elsewhere on this page are NOT supported by this source and must be re-sourced from the trial or guideline literature (their figures are not repeated here, because the point of this rebuild is to retire un-resourced dose numbers). On the contrary, this SPC restricts the drug to the intravenous route (see the route warning below). SPC §4.1 (indications) was not fetched, so the exact licensed indications behind 'local' and 'general' fibrinolysis cannot be quoted here. || VERBATIM SPC §4.2: 'Adults Unless otherwise prescribed, the following doses are recommended: 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 (BW)' || ROUTE — SAFETY (SPC §4.2, verbatim, capitals in the original): 'The administration is strictly limited to slow intravenous injection or infusion (see section 6.6) of maximum 1 mL per minute. TRANEXAMIC ACID SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY and should not be administered intrathecally or epidural (see sections 4.3 and 4.4). IN ORDER TO REDUCE THE RISK OF FATAL MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION OF TRANEXAMIC ACID, IT IS STRONGLY RECOMMENDED TO LABEL THE SYRINGES CONTAINING TRANEXAMIC ACID.' SPC §4.4 adds: 'Tranexamic acid must not be administered by the intramuscular route' and 'Serious adverse reactions including fatal events have been reported when tranexamic acid was inadvertently administered intrathecally. These events have included severe back, gluteal and lower limb pain, myoclonus and generalised seizures, and cardiac arrhythmias.' || MAXIMUM: the SPC states NO absolute daily ceiling for the IV regimens above, so none is published — do not infer one by multiplying the 6- to 8-hourly dose. || ELDERLY (§4.2, verbatim): 'No reduction in dosage is necessary unless there is evidence of renal failure.'

SPC §4.2, verbatim: 'Paediatric population 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. The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established. Currently available data are limited and are described in section 5.1.' SCOPE AND CAUTIONS: this is a TOTAL DAILY dose (mg/kg/day), NOT a per-dose figure — the SPC does not state how it is divided, does not state a paediatric maximum, and gives no dosing below 1 year. Section 4.1 (indications) was not retrieved in this bundle, so the 'current approved indications' this daily dose attaches to cannot be listed from the source. The 100 mg/mL concentration is the strength of the source product (Cyklokapron 100 mg/mL solution for injection/infusion). Verify any under-18 dose against a children's formulary before prescribing.