Posology Landiolol is intended for intravenous use in a monitored setting. Only a well-qualified health care professional should administer landiolol. The dosage of landiolol should be titrated individually. The infusion is usually started with an infusion rate of 10 - 40 micrograms/kg/min, which will establish the heartrate lowering effect within 10 - 20 min.
If rapid onset of the heartrate lowering effect is desired (within 2 to 4 min), an optional loading dose of 100 micrograms/kg/min for 1 min can be considered, followed by continuous intravenous infusion of 10 - 40 micrograms/kg/min.
Lower starting doses should be used for patients with cardiac dysfunction and septic shock. Dosing instructions are provided under “special populations” and in the integrated dosing scheme. 2), if the cardiovascular status of the patient requires and allows such an increase of the dose and the maximum daily dose is not exceeded.
, infusion of 40 micrograms/kg/min for 24 hours). There is limited experience with landiolol infusion durations beyond 24 hours for doses >10 μg/kg/min. 8), the dose of landiolol should be reduced or the infusion be discontinued, and patients should receive appropriate medical management if needed.
In the event of hypotension or bradycardia, administration of landiolol can be restarted at a lower dose after the blood pressure or heart rate have returned to an acceptable level. In patients with a low systolic blood pressure extra caution is needed when adjusting the dosage and during the maintenance infusion.
Transition to an alternative drug:
After achieving adequate control of the heart rate and a stable clinical status, transition to alternative medicinal products (such as oral antiarrhythmics) may be accomplished. When landiolol is replaced by alternative medicinal products, the physician should carefully consider the labelling and dosage of the alternative drug.
If switched to an alternative medicinal product the dosage of landiolol can be reduced as follows: • Within the first hour after the first dose of the alternative medicinal product has been administered, the infusion rate of landiolol should be reduced by one-half (50%).
• After administration of the second dose of the alternative medicinal product, the patient’s response should be supervised and if satisfactory control is maintained for a least one hour, the landiolol infusion can be discontinued.
Special populations Elderly population (≥ 65 years) No dose adjustment is necessary. 2). 2). Careful dosing starting with the lowest dose is recommended in patients with all degrees of hepatic impairment. , 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.
Further dose increases may be considered under close hemodynamic monitoring if required and tolerated by the patient´s cardiovascular status. Septic shock 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. Paediatric population The safety and efficacy of landiolol in children aged 0 to 18 years have not yet been established.
2, but no recommendation on posology can be made. 3). 6. 6). Contrary to other beta-blockers, landiolol did not show withdrawal tachycardia in response to abrupt termination after 24 h continuous infusion. Nevertheless, patients should be closely monitored when administration of landiolol is to be discontinued.