esmolol hydrochloride

FDA Drug Profile — esmolol hydrochloride, BREVIBLOC, Brevibloc, Esmolol Hydrochloride

esmolol hydrochloride is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including esmolol hydrochloride, BREVIBLOC, Brevibloc. Available dosage forms: injection, solution, injection.

Drug Details

Generic Name
esmolol hydrochloride
Brand Names
esmolol hydrochloride, BREVIBLOC, Brevibloc, Esmolol Hydrochloride
Application Number
ANDA207107
Sponsor
Sagent Pharmaceuticals
NDC Codes
9
Dosage Forms
INJECTION, SOLUTION, INJECTION
Routes
INTRAVENOUS
Active Ingredients
ESMOLOL HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE BREVIBLOC injection is a beta adrenergic blocker 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 ( 1.1 ) • Control of perioperative tachycardia and hypertension ( 1.2 ) 1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. BREVIBLOC injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. BREVIBLOC injection is intended for short-term use. 1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated. Use of BREVIBLOC injection to prevent such events is not recommended.