Landiolol
Generic Name: landiolol
Brand Names:
Rapiblyk
11 DESCRIPTION RAPIBLYK (landiolol) for injection is a beta-1 adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 4 minutes). Landiolol is: [(4S)-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2S)-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethylamino]propoxy]phenyl]propionate and has the following structure: The active pharmaceutical ingredient is the hydrochloride salt of landiolol, which has the empirical formula C 25 H 39 N 3 O 8 ∙ HCl and a...
Overview
11 DESCRIPTION RAPIBLYK (landiolol) for injection is a beta-1 adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 4 minutes). Landiolol is: [(4S)-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2S)-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethylamino]propoxy]phenyl]propionate and has the following structure: The active pharmaceutical ingredient is the hydrochloride salt of landiolol, which has the empirical formula C 25 H 39 N 3 O 8 ∙ HCl and a...
Uses
1 INDICATIONS AND USAGE RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter, and pediatric patients with supraventricular tachycardia. 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 ( 1 ), and pediatric patients with supraventricular tachycardia. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Administer as an intravenous infusion in a monitored setting. ( 2.1 ) Titrate according to ventricular rate. ( 2.1 ) In adults with 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. ( 2.1 ) In adults with 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. ( 2.1 ) In pediatric patients, 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.
Side Effects
6 ADVERSE REACTIONS The most common adverse reaction (9.9%) is hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AOP Orphan Pharmaceuticals at drugsafety.us@aop-health.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of RAPIBLYK was evaluated in 19 placebo-controlled clinical trials involving 1,761 adult patients (in a variety of clinical in-patient settings) with supraventricular tachycardia or at high risk for supraventricular tachycardia.
Interactions
7 DRUG INTERACTIONS Negative Inotropes and Chronotropes: Avoid ( 7.1 ) Sympathomimetics, Positive Inotropes and Vasoconstrictors: Avoid ( 7.2 ) Catecholamine Depleting Drugs: Monitor blood pressure and heart rate ( 7.3 ). 7.1 Negative Inotropes and Chronotropes Avoid concomitant use of RAPIBLYK with negative inotropes and medications that slow heart rate or cardiac conduction. Beta-blockers, like RAPIBLYK, can cause depression of myocardial contractility and increase the risk of bradycardia or heart block. Concomitant use of RAPIBLYK with negative inotropes or chronotropes may augment these effects [see Warnings and Precautions ( 5.2 )( 5.3 )] .
Warnings
5 WARNINGS AND PRECAUTIONS Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use ( 5.1 , 5.2 , 5.3 ) Risk of exacerbating reactive airway disease ( 5.5 ) Diabetes mellitus: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.6 ) Monitor for signs of myocardial ischemia when abruptly discontinuing in patients with coronary artery disease ( 5.10 ) 5.1 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. 4 CONTRAINDICATIONS RAPIBLYK is contraindicated in patients with: Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree [see Warnings and Precautions ( 5.2 )] . Decompensated heart failure [see Warnings and Precautions ( 5.3 )] . Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest.
Pregnancy
8.1 Pregnancy Risk Summary The available published data on RAPIBLYK use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Landiolol exposure was limited to a single injection at the time of Cesarean delivery in a small clinical trial. Neonatal bradycardia, hypoglycemia, and respiratory depression have been observed with use of beta-blockers in pregnancy near the time of delivery (see Clinical Considerations) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied RAPIBLYK is supplied as a white to almost white, preservative-free, lyophilized powder in single dose vials containing 280 mg landiolol for injection (equivalent to 300 mg landiolol HCl).
Frequently Asked Questions
What is Landiolol used for?▼
1 INDICATIONS AND USAGE RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter, and pediatric patients with supraventricular tachycardia. 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 ( 1 ), and pediatric patients with supraventricular tachycardia. ( 1 )
What are the side effects of Landiolol?▼
6 ADVERSE REACTIONS The most common adverse reaction (9.9%) is hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AOP Orphan Pharmaceuticals at drugsafety.us@aop-health.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of RAPIBLYK was evaluated in 19 placebo-controlled clinical trials involving 1,761 adult patients (in a variety of clinical in-patient settings) with supraventricular tachycardia or at high risk for supraventricular tachycardia.
Can I take Landiolol during pregnancy?▼
8.1 Pregnancy Risk Summary The available published data on RAPIBLYK use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Landiolol exposure was limited to a single injection at the time of Cesarean delivery in a small clinical trial. Neonatal bradycardia, hypoglycemia, and respiratory depression have been observed with use of beta-blockers in pregnancy near the time of delivery (see Clinical Considerations) .
What are the important warnings for Landiolol?▼
5 WARNINGS AND PRECAUTIONS Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use ( 5.1 , 5.2 , 5.3 ) Risk of exacerbating reactive airway disease ( 5.5 ) Diabetes mellitus: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.6 ) Monitor for signs of myocardial ischemia when abruptly discontinuing in patients with coronary artery disease ( 5.10 ) 5.1 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. 4 CONTRAINDICATIONS RAPIBLYK is contraindicated in patients with: Severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree [see Warnings and Precautions ( 5.2 )] . Decompensated heart failure [see Warnings and Precautions ( 5.3 )] . Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest.
Related Medications
Acid Phosd12, Nat Sulphd7, Lycopodiumd4, Syzygium Jambold8, Taraxacumd8, Uranium Nitd6, Uva Ursid8
acid phosd12, nat sulphd7, lycopodiumd4, syzygium jambold8, taraxacumd8, uranium nitd6, uva ursid8
Uses Temporarily relieves occasional blood sugar imbalances, thirst, and negative feelings. It supports healthy blood sugar levels. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Zincum Oxydatum
zincum oxydatum
Insulin Aspart Injection
insulin aspart injection
Insulin Analog [EPC]
11 DESCRIPTION Insulin aspart is a rapid-acting insulin analog for subcutaneous or intravenous administration. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae . Insulin aspart has the empirical formula C 256 H 381 N 65 0 79 S 6 and a molecular weight of 5825.8 daltons.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.