Landiolol

Landiolol is a prescription medication indicated for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.

• Landiolol is available under the following different brand names: Rapiblyk.

Common side effects of Landiolol include:

• hypotension

Serious side effects of Landiolol include:

• heart failure
• hypersensitivity reactions
• bronchospasm
• bradycardia
• hyperkalemic renal tubular acidosis

Rare side effects of Landiolol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, powder for reconstitution

• 280 mg single-dose vial (equivalent to 300 mg of landiolol HCl)

Supraventricular tachycardia

Adult dosage

• Administer as a continuous IV infusion, titrating as needed for heart rate (HR) control; data are limited beyond 24 hours of use
• Dosing for normal cardiac function
  • Starting dose: 9 mcg/kg/min
  • Titration interval: 10 min
  • Titration step: 9 mcg/kg/min
  • Maximum dose: 36 mcg/kg/min
  • Note: 9 mcg/kg/min Landiolol = 9.6 mcg/kg/min landiolol HCl
• Dosing for impaired cardiac function
  • Starting dose: 1 mcg/kg/min
  • Titration interval: 15 min
  • Titration step: 1 mcg/kg/min
  • Maximum dose: 36 mcg/kg/min
• Transition from landiolol to other therapy
  • Consider the pharmacodynamics of transitioning medication and monitor clinical response
  • If switched to oral beta-blocker
  • 10 min after administering oral beta-blocker, reduce landiolol infusion rate by 50%
  • If satisfactory control is maintained for 1 hour and more, discontinue landiolol

Dosage Considerations – Should be Given as Follows: 

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Landiolol has no noted severe interactions with any other drugs
• Landiolol has no noted serious interactions with any other drugs
• Landiolol has no noted moderate interactions with any other drugs
• Landiolol has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Severe sinus bradycardia, sick sinus syndrome, heart block greater than first-degree
• Decompensated heart failure
• Cardiogenic shock
• Pulmonary hypertension
• Hypersensitivity reactions, including anaphylaxis, to landiolol or any inactive ingredients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Landiolol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Landiolol?”

Cautions

• Hypotension
  • Increased risk of hypotension for patients with hemodynamic compromise, hypovolemia, or taking interacting medications
  • Monitor blood pressure (BP) closely, especially if pretreatment blood pressure is low
  • Reduce or stop infusion for hypotension; expect BP effect to wane within 30 min
• Bradycardia
  • Increased risk of bradycardia (including sinus pause, heart block, severe bradycardia, and cardiac arrest) in patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders
• Monitor HR and rhythm
  • Reduce or stop infusion for bradyarrhythmia
• Cardiac failure
  • Beta-blockers can depress myocardial contractility and may precipitate heart failure and cardiogenic shock.
  • Stop infusion at the first sign or symptom of impending cardiac failure and start supportive therapy
• Reactive airways disease
  • Generally, patients with reactive airway disease should not receive beta-blockers
  • Because of its relative beta1 selectivity and titratability, landiolol may be titrated to the lowest possible effective dose
  • Stop infusion immediately if bronchospasm occurs; may administer a beta-2 stimulating agent with appropriate monitoring of ventricular rates
• Patients with diabetes mellitus and hypoglycemia
  • Beta-blockers may prevent early warning signs of hypoglycemia (e.g., tachycardia) and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus, patients who are fasting (i.e., surgery, not eating regularly, or are vomiting), or children
  • Monitor for signs and symptoms of hypoglycemia
• Infusion site reactions
  • Infusion site reactions (e.g., pain, swelling, erythema) reported
  • Avoid infusions into small veins or through a butterfly catheter
  • If local infusion site reaction develops, use an alternate infusion site and avoid extravasation
• Patients with Prinzmetal angina
  • Beta-blockers may exacerbate anginal attacks in patients with Prinzmetal angina owing to unopposed alpha receptor-mediated coronary artery vasoconstriction
• Patients with pheochromocytoma
  • If used in the setting of pheochromocytoma, administer in combination with an alpha-blocker, and only after the alpha-blocker is initiated
  • Administration of beta-blockers without opposing alpha blockade in the setting of pheochromocytoma associated with paradoxical increase in BP owing to attenuation of beta receptor-mediated vasodilation in skeletal muscle
• Patients with peripheral circulatory disorders
  • May exacerbate peripheral circulatory disorders (e.g., Raynaud disease or syndrome, peripheral occlusive vascular disease)
• Abrupt discontinuation
  • Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias were reported in patients with coronary artery disease upon abrupt discontinuation of beta-blocker therapy
  • Observe for signs of myocardial ischemia when discontinuing
• Hyperkalemia
  • Beta-blockers can cause increased serum potassium and hyperkalemia
  • Risk increased with risk factors (e.g., renal impairment)
  • IV administration of beta blockers reported to cause potentially life-threatening hyperkalemia in patients undergoing hemodialysis
• Monitor serum electrolytes
  • Patients with metabolic acidosis
  • Beta-blockers reported to cause hyperkalemic renal tubular acidosis
  • Acidosis may be associated with reduced cardiac contractility
• Patients with hyperthyroidism
  • Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism
  • Abrupt withdrawal of beta-blockade might precipitate a thyroid storm; therefore, monitor for signs of thyrotoxicosis when withdrawing beta-blocking therapy
• Patients at risk of severe acute hypersensitivity reactions
  • When using beta-blockers, patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic)
  • Beta-blockers may render the patient unresponsive to usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions
• Drug interaction overview
  • Negative inotropes and chronotropes
    • Avoid coadministration with negative inotropes and medications that slow HR or cardiac conduction
    • Beta-blockers can depress myocardial contractility and increase the risk of bradycardia or heart block
    • Coadministration of beta blockers with negative inotropes or chronotropes may augment these effects
  • Sympathomimetics, positive inotropes, and vasoconstrictors
    • Use caution
    • Beta-adrenergic agonists will antagonize the effects of beta-blockers and may attenuate HR, lowering the effects of landiolol
    • Positive inotropes and vasoconstrictors may attenuate HR and BP of beta blockers
  • Catecholamine-depleting drugs
  • Monitor
    • Observe patients treated with beta-blockers plus a catecholamine depletion (e.g., reserpine, monoamine oxidase inhibitors) for hypotension or marked bradycardia, which may cause vertigo, syncope, or postural hypotension
    • Catecholamine-depleting drugs may have an additive effect when given with beta-blockers, which may increase the risk of hypotension or marked bradycardia-related vertigo, syncope, or postural hypotension

Pregnancy and Lactation

• Data are insufficient in pregnant women to assess drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Neonatal bradycardia, hypoglycemia, and respiratory depression observed with the use of beta-blockers in pregnancy near the time of delivery
• Clinical considerations
  • Landiolol crosses the placenta in rats
  • Neonates born to mothers who are receiving landiolol during pregnancy may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression
  • Monitor neonates exposed during pregnancy and labor for hypotension, hypoglycemia, bradycardia, and respiratory depression and manage accordingly
• Lactation
  • Data are unavailable on the presence of landiolol and its metabolites in human milk, its effects on breastfed infants, or its effects on milk production
  • However, other beta-blockers are detected in human milk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for landiolol and any potential adverse effects on the breastfed infant or from the underlying maternal condition
  • Monitor breastfed infants for bradycardia and other symptoms of beta-blockade (e.g., lethargy [hypoglycemia])