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Landiolol parenteral

Presentation

Parenteral formulations of landiolol.

Drugs List

  • landiolol 300mg powder for solution for infusion vial
  • RAPIBLOC 300mg powder for solution for infusion vial
  • Therapeutic Indications

    Uses

    Cardiac arrhythmias especially supraventricular tachycardia
    Non-compensatory sinus tachycardia

    Supraventricular tachycardia and rapid control of ventricular rate in patients with atrial flutter or atrial fibrillation in perioperative, postoperative, or other situations where short-term control of the ventricular rate with a short acting agent is desirable.

    Non-compensatory sinus tachycardia where the rapid heart rate requires specific intervention.

    Dosage

    Adults

    Initial dose is 10 to 40micrograms/kg/minute. This will establish the heart rate lowering effect within 10 to 20 minutes.
    If a quicker onset of heart rate lowering effect is required (within 2 to 4 minutes), an optional loading dose of 100micrograms/kg/minute for 1 minute can be considered, followed by continuous infusion of 10 to 40micrograms/kg/minute.

    The maintenance infusion rate may be increased to a maximum of 80micrograms/kg/minute if required, and if tolerated by the patient.
    The maximum daily dose is 57.6mg/kg/day (based on a dose of 40micrograms/kg/minute over a maximum duration of 24 hours).

    Additional Dosage Information

    Patients with cardiac dysfunction (impaired left ventricular function)
    Initial dose of 1microgram/kg/minute. This can be titrated up, whilst closely monitoring blood pressure, to 10micrograms/kg/minute.

    Switching to an alternative drug
    Switching to another drug, such as oral antiarrhythmics, may only be considered when adequate control of the heart rate has been achieved.
    When switching to an alternative drug, the infusion rate of landiolol should be reduced by 50% within the first hour after the first dose of the alternative drug being administered. Following administration of the second dose of the alternative product, the patients response should be monitored and if satisfactory control is maintained for at least 1 hour, the landiolol infusion may be discontinued.

    Administration

    For intravenous administration via a central or peripheral line.

    Contraindications

    Children under 18 years
    Acute asthma
    Breastfeeding
    Cardiogenic shock
    Decompensated cardiac failure
    Non paced second/third degree AV block
    Pre-excitation syndrome with atrial fibrillation
    Pulmonary hypertension
    Severe bradycardia
    Severe hypotension
    Severe metabolic acidosis
    Severe sinus node dysfunction
    Uncontrolled phaeochromocytoma

    Precautions and Warnings

    Bronchospastic disorder
    Cardiac failure
    Diabetes mellitus
    First degree atrioventricular block
    Hepatic impairment
    Hypoglycaemia
    Hypotension
    Intermittent claudication
    Phaeochromocytoma
    Pregnancy
    Prinzmetal's angina
    Raynaud's syndrome
    Renal impairment

    Consider reducing initial dose in hepatic impairment
    Reduce dose in patients with cardiac dysfunction
    Not recommended for chronic administration
    Administer reconstituted solution immediately
    Monitor blood pressure continuously
    Monitor ECG
    Beta blockers may reduce the response to adrenaline in anaphylaxis
    Hypoglycaemic symptoms may be masked/altered with beta blockers
    May aggravate symptoms of peripheral arterial circulatory disorders
    Avoid dose increments and consider discontinuation if condition worsens
    Discontinue if bronchospasm occurs
    Maximum treatment 24 hours

    In the event of an adverse reaction to landiolol, it is recommended to reduce the dose or discontinue the infusion. If hypotension or bradycardia has occurred, administration may be restarted at a lower dose after the blood pressure or heart rate has returned to a satisfactory level.

    Caution is advised during maintenance infusion and dose adjustment in patients with low systolic blood pressure.

    When treating patients with pre-existing cardiac failure, patients who are haemodynamically compromised or patients or are taking drugs which 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.

    Pregnancy and Lactation

    Pregnancy

    Use landiolol with caution during pregnancy.

    The manufacturer does not recommend using landiolol during pregnancy. At the time of writing there is limited published information regarding the use of landiolol during pregnancy. The general side effects on the foetus and neonate of beta-blocker use during late pregnancy, including hypoglycaemia, hypotension and bradycardia, should be taken into account. If treatment with landiolol is considered necessary, foetal growth and uteroplacental blood flow should be monitored. The newborn must be monitored closely.

    Lactation

    Landiolol is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues landiolol or discontinues breastfeeding. Animal data reports excretion of landiolol into breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown.

    Side Effects

    Abdominal discomfort
    Acute kidney injury
    Altered liver function tests
    Asthma
    Atrial fibrillation
    Atrioventricular block
    Blood dyscrasias
    Bradycardia
    Bronchospasm
    Cardiac arrest
    Cerebral infarct
    Cerebral ischaemia
    Cerebrovascular accident
    Chest discomfort
    Chills
    Cold sweat
    Decrease in blood pressure
    Decreased cardiac output
    Dyspnoea
    ECG changes
    Erythema
    Extrasystoles
    Headache
    Hepatic disorders
    Hot flushes
    Hyperbilirubinaemia
    Hyperglycaemia
    Hypertension
    Hyponatraemia
    Hypotension
    Hypoxia
    Impaired platelet function
    Injection site reactions
    Local pain (injection site)
    Mediastinitis
    Muscle spasm
    Myocardial infarction
    Nausea
    Oliguria
    Oral discharge
    Pneumonia
    Possible alteration of laboratory tests
    Pulmonary oedema
    Pyrexia
    Renal failure
    Respiratory disorders
    Respiratory distress
    Right bundle branch block
    Seizures
    Sensation of pressure
    Shock
    Sinus arrest
    Tachycardia
    Thrombocytopenia
    Unpleasant breath
    Ventricular tachycardia
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: January 2023

    Reference Sources

    Summary of Product Characteristics: Rapibloc 300mg powder for solution for infusion. AOP Orphan Ltd. Revised June 2022.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.