First Generic Esmolol Hydrochloride Product Launched for Tachycardia

SEPTEMBER 13, 2018
Kristen Coppock, MA, Editor

Mylan has launched the first generic version of esmolol hydrochloride (Brevibloc, Baxter) in the United States for treatment of tachycardia.1 According to Mylan, Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag products are being offered to the global pharmaceutical company’s institutional customers.

Mylan’s esmolol hydrochloride products are in the market following FDA approval of an Abbreviated New Drug Application (ANDA). Esmolol Hydrochloride in Sodium Chloride Injection is indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia, including atrial fibrillation and atrial flutter, and control of heart rate in noncompensatory sinus tachycardia, and control of perioperative tachycardia and hypertension.1

Brevibloc is contraindicated in patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, or overt cardiac failure. The drug should also not be used for treatment of hypertension due primarily to vasoconstriction associated with hypothermia or to prevent tachycardia and/or hypertension.2 In addition, Baxter is cautioning Brevibloc users to carefully monitor during infusion for patients with LV dysfunction, CHF, hypotension, reactive airway disease, and diabetes. Generally, patients with bronchospastic disease should not receive beta blockers, according to Baxter. Due to the relative beta1 selectivity and titratability, esmolol hydrochloride may be used with caution in patients with bronchospastic disease, titrated to the lowest possible dose.2

The most common adverse effect with Brevibloc is hypotension; asymptomatic (25%) and symptomatic (12%), mainly dizziness and diaphoresis. Hypotension usually reverses within 30 minutes of decrease of dose or termination of infusion. Infusion site reactions (8%) have also been reported.2

 
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References
  1. Mylan Adds to Cardiovascular Portfolio With Launch of First Generic of Brevibloc® Injection in Single-Dose Bags [news release]. Hertfordshire, England and Pittsburgh, Pennsylvania; September 13, 2018: Mylan N.V. http://investor.mylan.com/node/27551/pdf. Accessed September 13, 2018. 
  2. Products: Brevibloc (esmolol hydrochloride). Baxter website. http://www.baxter.com.pr/healthcare_professionals/products/brevibloc.html. Accessed September 13, 2018.



 

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