Landiolol hydrochloride

The page is 'Landiolol hydrochloride', an ultra-short-acting beta-1 blocker given IV for rapid heart-rate control (Cardiology / Anaesthesia & Critical Care), and its only listed brand is Rapibloc. The fetched product is that exact brand, that exact route and that exact use. §4.1 verbatim: 'Landiolol is indicated in adults for: Supraventricular tachycardia and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short acting agent is desirable. Non-compensatory sinus tachycardia where, in the physician's judgment the rapid heart rate requires specific intervention. Landiolol is not intended for use in chronic settings.' That clause has been removed and replaced with the SPC's own values, re-checked against both the printed conversion table and the SPC's formula. The earlier 'NO OPEN SOURCE: Rapibloc - eMC 0' note is also stale. PREPARATION AND RATE CONVERSION (§4.2, for the Rapibloc 300 mg/50 ml presentation only, i.e. 6 mg/ml). Formula verbatim: 'Target dose (micrograms /kg/min) x body weight (kg)/100 = infusion rate (ml/h)'. Optional bolus for haemodynamically stable patients, verbatim: 'Loading dose infusion rate (ml/h) for 1 minute = body weight (kg) (Example: 70 ml/h loading dose infusion rate for 1 minute for a 70 kg patient)'. From the SPC's printed conversion table: a 50 kg patient at 20 micrograms/kg/min is 10 ml/h, and a 100 kg patient at 40 micrograms/kg/min is 40 ml/h — both agree with the formula. Rapibloc must be reconstituted before administration and used immediately after opening; it must not be mixed with other medicinal products except those listed in §6.6, and must not be administered through the same intravenous line as other medicinal products. LOWER STARTING DOSES IN TWO SPECIFIC SUB-POPULATIONS — the SPC's own figures, not extrapolations. Cardiac dysfunction, verbatim: 'In patients with impaired left ventricular function (LVEF <40%, CI <2.5 L/min/m 2 , NYHA 3-4) e.g., after cardiac surgery, during ischemia or in septic states, lower doses starting from 1 microgram/kg/min and increased in a stepwise fashion under close blood pressure monitoring up to 10 micrograms/kg/min have been used to achieve heart rate control.' Septic shock, verbatim: 'In patients with septic shock lower doses starting from 1 microgram/kg/min up to a maximum of 40 micrograms/kg/min have been used to achieve heart rate control. The dose was increased in increments of 1 microgram/kg/min with a minimum dose interval of 20 minutes under close blood pressure monitoring.' DURATION: 'There is limited experience with landiolol infusion durations beyond 24 hours for doses >10 micrograms/kg/min.' DOSE REDUCTION AND STOPPING: in an adverse reaction the dose should be reduced or the infusion discontinued; after hypotension or bradycardia, landiolol can be restarted at a lower dose once blood pressure or heart rate have returned to an acceptable level. Extra caution when adjusting the dose and during maintenance infusion in patients with a low systolic blood pressure. TRANSITION TO AN ALTERNATIVE DRUG: within the first hour after the first dose of the alternative medicinal product, reduce the landiolol infusion rate by one-half (50%); after the second dose of the alternative product, supervise the response and if satisfactory control is maintained for at least one hour the landiolol infusion can be discontinued. Unlike other beta-blockers, landiolol did not show withdrawal tachycardia after abrupt termination of a 24 h continuous infusion, but patients should still be closely monitored at discontinuation. PAEDIATRIC: none published, and none exists in this SPC — §4.2 verbatim: 'The safety and efficacy of landiolol in children aged 0 to 18 years have not yet been established. Currently available data are described in section 5.2, but no recommendation on posology can be made.' paedDose is deliberately null so that no weight calculation can run. §4.4 (which absorbs §4.5 interactions) and §4.8 both end with the source-fetch truncation marker — nothing has been taken from beyond those points, the §4.4 anaesthesia-interaction sentence is cut mid-sentence, and the side-effect and interaction lists below are therefore PARTIAL.