Active Ingredient: Landiolol
Non-compensatory sinus tachycardia where, in the physician’s judgment the rapid heart rate requires specific intervention.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
10 - 100 ug per kg of body weight
From 10 To 100 ug per kg of body weight once every day for 1 day(s)
100 ug per kg of body weight
Landiolol is intended for intravenous use in a monitored setting. Only a well-qualified health care professional should administer landiolol. The dosage of landiololshould be titrated individually.
Initiate the intravenous infusion by a loading dose of 100 micrograms/kg body weight (BW) for 1 min, followed by continuous intravenous infusion of 10-40 micrograms/kg BW/min. If no rapid onset of the bradycardic effect (within 2 to 4 min) is required, starting the infusion with the maintenance infusion rate of 10-40 micrograms/kg BW/min will establish the effect within 10-20 min.
Maximum dose: Should the desired therapeutic response not be achieved with this dosing regimen, the maintenance dose may be increased up to 80 micrograms/kg BW/min, if the cardiovascular status of the patient requires and allows such an increase of the dose.
Conversion table for the initial intravenous infusion from micrograms/kg/min to ml/h (Landiolol 300 mg/50 ml = 6 mg/ml strength):
| kg body weight | 100 µg/kg for 1 minute | |
|---|---|---|
| 40 | 40 | ml/h |
| 50 | 50 | ml/h |
| 60 | 60 | ml/h |
| 70 | 70 | ml/h |
| 80 | 80 | ml/h |
| 90 | 90 | ml/h |
| 100 | 100 | ml/h |
Conversion table for continuous intravenous infusion: micrograms /kg/min to ml/h (Landiolol 300 mg/50 ml = 6 mg/ml strength):
| kg body weight | 10 µg/kg/min | 20 µg/kg/min | 30 µg/kg/min | 40 µg/kg/min | 80 µg/kg/min | |
|---|---|---|---|---|---|---|
| 40 | 4 | 8 | 12 | 16 | 32 | ml/h |
| 50 | 5 | 10 | 15 | 20 | 40 | ml/h |
| 60 | 6 | 12 | 18 | 24 | 48 | ml/h |
| 70 | 7 | 14 | 21 | 28 | 56 | ml/h |
| 80 | 8 | 16 | 24 | 32 | 64 | ml/h |
| 90 | 9 | 18 | 27 | 36 | 72 | ml/h |
| 100 | 10 | 20 | 30 | 40 | 80 | ml/h |
Conversion table for the initial intravenous infusion from micrograms/kg/min to ml/h (Landiolol 600 mg/50 ml = 12 mg/ml strength):
| kg body weight | 100 µg/kg for 1 minute | |
|---|---|---|
| 40 | 20 | ml/h |
| 50 | 25 | ml/h |
| 60 | 30 | ml/h |
| 70 | 35 | ml/h |
| 80 | 40 | ml/h |
| 90 | 45 | ml/h |
| 100 | 50 | ml/h |
Conversion table for continuous intravenous infusion: micrograms/kg/min to ml/h (Landiolol 600 mg/50 ml = 12 mg/ml strength):
| kg body weight | 1Landiolol0 µg/kg/min | 20 µg/kg/min | 30 µg/kg/min | 40 µg/kg/min | 80 µg/kg/min | |
|---|---|---|---|---|---|---|
| 40 | 2 | 4 | 6 | 8 | 16 | ml/h |
| 50 | 2.5 | 5 | 7.5 | 10 | 20 | ml/h |
| 60 | 3 | 6 | 9 | 12 | 24 | ml/h |
| 70 | 3.5 | 7 | 10.5 | 14 | 28 | ml/h |
| 80 | 4 | 8 | 12 | 16 | 32 | ml/h |
| 90 | 4.5 | 9 | 13.5 | 18 | 36 | ml/h |
| 100 | 5 | 10 | 15 | 20 | 40 | ml/h |
The maximum recommended daily dose of landiolol is 8,064 mg/subject/day (based on 80 micrograms/kg BW/min for a 70 kg patient and a maximum infusion duration of 24 hours). There is limited experience with landiolol infusion durations beyond 24 hours.
In case of an adverse reaction, 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, and the dosage of landiolol can be reduced as follows:
Landiolol should be administered intravenously via a central line or a peripheral line and should not be administered through the same intravenous line as other medicinal products.
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