RAPIBLOC

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.

a. Summary of the safety profile The most frequently observed adverse drug reaction (ADR) reported for clinical trials (2382patients) and for postmarketing treatment outcome studies/use surveys (1,257 patients) for landiolol were hypotension and bradycardia (≥1 to <10 %).

ADRs are tabulated below by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

b. e. placebo-, active-, no treatment-controlled, as well as uncontrolled studies), in which 2264 patients were treated with landiolol c. 7%, respectively (of 1,257 patients). All cases of hypotension and bradycardia related to landiolol treatment in the described studies resolved or improved, without any action being taken or within minutes after discontinuation of landiolol and/or additional treatment.

Serious adverse events based on clinical studies/postmarketing use surveys: shock due to excessive hypotension was reported in one perioperative clinical trial patient with heavy bleeding (the event resolved 10 minutes after landiolol, prostaglandine and isoflurane discontinuation).

Cardiac arrest, complete AV block, sinus arrest, and severe bradycardia reported from clinical trials and post-marketing surveillance for landiolol treatment were mainly associated with elderly patients or with patients having hypertension or cardiac diseases as complications.

2. d. 0%] patient). There are limited safety data for the use of landiolol in the elderly. Uncertainties regarding the safety profile of landiolol need to be considered, as adverse events could also result from the use of co-medications or from the anaesthesia.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Rapibloc must be reconstituted before administration and used immediately after opening (see section 6). The most frequently observed side effect is hypotension which is rapidly reversible with dosage reduction or discontinuation. Monitoring It is advised to continuously monitor the blood pressure and the ECG in all patients treated with landiolol.

Pre-excitation syndrome Beta-blockers should be avoided in patients with pre-excitation syndrome in combination with atrial fibrillation. In these patients beta-blockade of the atrioventricular node may increase the conduction through the accessory pathway and may precipitate ventricular fibrillation.

3). Prinzmetal’s angina Beta-blockers may increase the number and the duration of anginal attacks in patients with Prinzmetal’s angina (vasospastic angina) due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Non-selective beta-blockers should not be used for these patients and beta-1 selective blockers only with the utmost care.

Heart failure and hemodynamically compromised patients The use of landiolol for the control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution in patients with (pre- existing) heart failure or when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.

The benefits of potential rate control should be balanced against the risk of further depressing myocardial contractility. At the first sign or symptom of further worsening, dose should not be increased and, if considered necessary, landiolol should be discontinued and patients should receive appropriate medical management.

5). Diabetic patients Landiolol should be used with caution in diabetics or in case of hypoglycaemia. Hypoglycaemia is more severe with less cardio-selective beta-blockers. Beta-blockers can mask the prodromal symptoms of hypoglycaemia such as tachycardia.

1. - Severe bradycardia (less than 50 beats per minute) - Sick sinus syndrome - Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block - Cardiogenic shock - Severe hypotension - Decompensated heart failure when considered not related to the arrhythmia - Pulmonary hypertension - Non-treated phaeochromocytoma - Acute asthmatic attack - Severe, uncorrectable metabolic acidosis