Landiolol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh
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Overview
Landiolol is a beta adrenergic blocker that is FDA approved for the treatment of for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.. Common adverse reactions include hypotension..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- RAPIBLYK is a beta adrenergic blocker indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.
• Administer as an intravenous infusion in a monitored setting.
• Titrate according to ventricular rate.
• If normal cardiac function, start at 9 mcg/kg/min; adjust dose in 10-minute intervals as needed in increments of 9 mcg/kg/min to a maximum of 36 mcg/kg/min.
• If impaired cardiac function, start at 1 mcg/kg/min; adjust dose in 15-minute intervals as needed in increments of 1 mcg/kg/min to a maximum of 36 mcg/kg/min.
• For injection: 280 mg of landiolol (equivalent to 300 mg of landiolol HCl) as a lyophilized powder in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Landiolol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Landiolol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Landiolol FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Landiolol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Landiolol in pediatric patients.
Contraindications
RAPIBLYK is contraindicated in patients with:
- Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree.
- Decompensated heart failure.
- Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest.
- Pulmonary hypertension: May precipitate cardiorespiratory decompensation.
- Hypersensitivity reactions, including anaphylaxis, to landiolol or any of the inactive ingredients
Warnings
Hypotension
- Patients with hemodynamic compromise, hypovolemia, or on interacting medications are at increased risk of hypotension. Monitor blood pressure closely, especially if pretreatment blood pressure is low. Reduce or stop RAPIBLYK injection for hypotension then expect the blood pressure effect to wane within 30 minutes.
Bradycardia
- Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders are at increased risk of bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest. Monitor heart rate and rhythm in patients receiving RAPIBLYK injection. Reduce or stop RAPIBLYK injection for bradyarrhythmia.
Cardiac Failure
- Beta-blockers, like RAPIBLYK, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. At the first sign or symptom of impending cardiac failure, stop RAPIBLYK injection and start supportive therapy.
Reactive Airways Disease
- Patients with reactive airways disease should, in general, not receive beta-blockers. Because of its relative beta-1 selectivity and titratability, RAPIBLYK injection may be titrated to the lowest possible effective dose. In the event of bronchospasm, stop the infusion immediately; a beta-2 stimulating agent may be administered with appropriate monitoring of ventricular rates.
Use in Patients with Diabetes Mellitus and Hypoglycemia
- Beta-blockers may prevent early warning signs of hypoglycemia, such as 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 in patients receiving RAPIBLYK.
Infusion Site Reactions
- Infusion site reactions such as pain, swelling and erythema have occurred with the use of RAPIBLYK injection. Avoid infusions into small veins or through a butterfly catheter. If a local infusion site reaction develops, use an alternative infusion site and avoid extravasation.
Use in Patients with Prinzmetal’s Angina
- Beta-blockers may exacerbate anginal attacks in patients with Prinzmetal’s angina because of unopposed alpha receptor–mediated coronary artery vasoconstriction.
Use in Patients with Pheochromocytoma
- If RAPIBLYK injection is used in the setting of pheochromocytoma, administer RAPIBLYK in combination with an alpha-blocker, and only after the alpha-blocker has been initiated. Administration of beta-blockers without opposing alpha blockade in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure from the attenuation of beta receptor-mediated vasodilation in skeletal muscle.
Use in Patients with Peripheral Circulatory Disorders
- RAPIBLYK injection may exacerbate peripheral circulatory disorders, such as Raynaud’s disease or syndrome, and peripheral occlusive vascular disease.
Abrupt Discontinuation of RAPIBLYK Injection
- Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease upon abrupt discontinuation of beta-blocker therapy. Observe patients for signs of myocardial ischemia when discontinuing RAPIBLYK injection.
Hyperkalemia
- Beta-blockers, including RAPIBLYK injection, can cause increases in serum potassium and hyperkalemia. The risk is increased in patients with risk factors such as renal impairment. Intravenous administration of beta-blockers has been reported to cause potentially life-threatening hyperkalemia in hemodialysis patients. Monitor serum electrolytes during therapy with RAPIBLYK injection.
Use in Patients with Metabolic Acidosis
- Beta-blockers have been reported to cause hyperkalemic renal tubular acidosis. Acidosis in general may be associated with reduced cardiac contractility.
Use in Patients with Hyperthyroidism
- Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate thyroid storm; therefore, monitor patients for signs of thyrotoxicosis when withdrawing beta blocking therapy.
Use in 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).
- Patients using beta-blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Landiolol Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Landiolol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Landiolol Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Landiolol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Landiolol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Landiolol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Landiolol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Landiolol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Landiolol in geriatric settings.
Gender
There is no FDA guidance on the use of Landiolol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Landiolol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Landiolol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Landiolol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Landiolol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Landiolol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Landiolol Administration in the drug label.
Monitoring
There is limited information regarding Landiolol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Landiolol and IV administrations.
Overdosage
There is limited information regarding Landiolol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Landiolol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Landiolol Mechanism of Action in the drug label.
Structure
There is limited information regarding Landiolol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Landiolol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Landiolol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Landiolol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Landiolol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Landiolol How Supplied in the drug label.
Storage
There is limited information regarding Landiolol Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Landiolol Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Landiolol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Rapiblyk
Look-Alike Drug Names
There is limited information regarding Landiolol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.