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Esmolol - Brevibloc ®
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
2500 mg – 250 mL in Ready-to-use 250 mL
Stability / Miscellaneous
Minimum Dilution: Note: The use of esmolol with propylene glycol has been associated with a higher incidence of venous irritation at concentrations greater than 10 mg/mL on continued infusion. Mixed from the ampul at concentrations of greater than 10 mg/mL BREVIBLOC has, however, been well tolerated when administered via a central vein. A premixed bag is available from the manufacturer: 2000 mg/100 ml (solution osmolarity adjusted to 312 mOsmol/L).
Onset of action: I.V.: 2 to10 minutes (quickest when loading doses are administered)
INDICATIONS AND USAGE
Intraoperative and Postoperative Tachycardia and/or Hypertension
Use of BREVIBLOC to prevent such events is not recommended.
DOSAGE AND ADMINISTRATION
An initial loading dose of 0.5 milligrams/kg (500 micrograms/kg) infused over a minute duration followed by a maintenance infusion of 0.05 milligrams/kg/min (50 micrograms/kg/min) for the next 4 minutes is recommended. This should give a rough guide with respect to the responsiveness of ventricular rate.
After the 4 minutes of initial maintenance infusion (total treatment duration being 5 minutes), depending upon the desired ventricular response, the maintenance infusion may be continued at 0.05 mg/kg/min or increased step-wise (e.g. 0.1 mg/kg/min, 0.15 mg/kg/min to a maximum of 0.2 mg/kg/min) with each step being maintained for 4 or more minutes.
If more rapid slowing of ventricular response is imperative, the 0.5 mg/kg loading dose infused over a 1 minute period may be repeated, followed by a maintenance infusion of 0.1 mg/kg/min for 4 minutes. Then, depending upon ventricular rate, another (and final) loading dose of 0.5 mg/kg/min infused over a 1 minute period may be administered followed by a maintenance infusion of 0.15 mg/kg/min. If needed, after 4 minutes of the 0.15 mg/kg/min maintenance infusion, the maintenance infusion may be increased to a maximum of 0.2 mg/kg/min.
In the absence of loading doses, constant infusion of a single concentration of esmolol reaches pharmacokinetic and pharmacodynamic steady-state in about 30 minutes. Maintenance infusions (with or without loading doses) may be continued for as long as 24 hours.
The following table summarizes the above and assumes that 3 loading doses (the maximum recommended) are infused over 1 minute and incremental maintenance doses are required after each loading dose. There should be no 4th loading dose, but the maintenance dose may be incremented one more time.
In the treatment of supraventricular tachycardia, responses to BREVIBLOC (Esmolol Hydrochloride) usually (over 95%) occur within the range of 50 to 200 micrograms/kg/min (0.05 to 0.2 milligrams/kg/min). The average effective dosage is approximately 100 micrograms/kg/min (0.1 milligrams/kg/min) although dosages as low as 25 micrograms/kg/min (0.025 milligrams/kg/min) have been adequate in some patients. Dosages as high as 300 micrograms/kg/min (0.3 milligrams/kg/min) have been used, but these provide little added effect and increase the rate of adverse effects, so doses greater than 200 micrograms/kg/min are not recommended. Dosage of BREVIBLOC in supraventricular tachycardia must be individualized by titration in which each step consists of a loading dosage followed by a maintenance dosage.
This specific dosage regimen has not been studied intraoperatively and, because of the time required for titration, may not be optimal for intraoperative use.
The safety of dosages above 300 mcg/kg/min (0.3 mg/kg/min) has not been studied.
In the event of an adverse reaction, the dosage of BREVIBLOC may be reduced or discontinued. If a local infusion site reaction develops, an alternate infusion site should be used and caution should be taken to prevent extravasation. The use of butterfly needles should be avoided.
Abrupt cessation of BREVIBLOC in patients has not been reported to produce the withdrawal effects which may occur with abrupt withdrawal of beta blockers following chronic use in coronary artery disease (CAD) patients. However, caution should still be used in abruptly discontinuing infusions of BREVIBLOC in CAD patients.
After achieving an adequate control of the heart rate and a stable clinical status in patients with supraventricular tachycardia, transition to alternative antiarrhythmic agents such as propranolol, digoxin, or verapamil, may be accomplished.
A recommended guideline for such a transition is given below but the physician should carefully consider the labeling instructions for the alternative agent selected.
The dosage of BREVIBLOC (Esmolol Hydrochloride) should be reduced as follows:
1. Thirty minutes following the first dose of the alternative agent, reduce the infusion rate of BREVIBLOC by one-half (50%).
The use of infusions of BREVIBLOC up to 24 hours has been well documented; in addition, limited data from 24-48 hrs (N=48) indicate that BREVIBLOC is well tolerated up to 48 hours.
INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
Directions for Use of Brevibloc Premixed Injection (10 mg/mL) and Brevibloc DOUBLE STRENGTH Premixed Injection (20 mg/mL)
This dosage form is prediluted to 100 or 250 mL to provide a ready-to-use, iso-osmotic solution of either 20 or 10 mg/mL esmolol hydrochloride in sodium chloride. It is important not to introduce additives to BREVIBLOC PREMIXED INJECTION or BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION. See Directions for Use of the Premixed Bag for additional information.
Directions for Use of the Premixed Bag
Brevibloc DOUBLE STRENGTH Premixed Injection (20 mg/mL) 100 mL IntraVia Bag
BREVIBLOC PREMIXED INJECTION (10 mg/mL) and BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION (20 mg/mL) are provided in ready-to-use, non-latex, non-PVC bags with two PVC ports, a medication port and a delivery port. The medication port is to be used solely for withdrawing an initial bolus from the bag; the medication withdrawal port is not intended for repeat bolus administration. The sterility of the premixed bag cannot be assured after repeat withdrawals from the bag. The use of aseptic technique is required when withdrawing the bolus dose. Do not add any additional medications to BREVIBLOC PREMIXED INJECTION. Each bag is for single-patient use only and contains no preservative. It is advised that once drug has been withdrawn from BREVIBLOC PREMIXED INJECTION, the bag should be used within 24 hours, with any unused portion discarded.
The Brevibloc Premixed Injection contains Esmolol Hydrochloride at a concentration of 10 milligrams/mL. When using a 10 milligrams/mL concentration, a loading dose of 0.5 milligrams/kg infused over 1 minute period of time, for a 70 kg patient, is 3.5 mL. The loading dose can be removed from the medication port of the premixed bag.
The Brevibloc DOUBLE STRENGTH Premixed Injection contains Esmolol Hydrochloride at a concentration of 20 milligrams/mL. When using a 20 milligrams/mL concentration, a loading dose of 0.5 milligrams/kg infused over 1 minute period of time, for a 70 kg patient, is 1.75 mL. The loading dose can be removed from the medication port of the premixed bag.
Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not use unless the solution is clear, colorless to light yellow, and the seal is intact.
Fill out the patient information label supplied and apply to the inner bag.
Do not introduce additives to BREVIBLOC PREMIXED INJECTION or BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION.
PREPARATION FOR INTRAVENOUS ADMINISTRATION
1. Suspend premixed bag from eyelet support.
Directions for Use of the Ready-to-use Vials
This dosage form is prediluted to provide a ready-to-use, iso-osmotic solution of either 10 or 20 mg/mL esmolol hydrochloride in sodium chloride recommended for BREVIBLOC intravenous administration. It may be used to administer the appropriate BREVIBLOC (Esmolol Hydrochloride) loading dosage infusions by hand-held syringe while the maintenance infusion is being prepared.
The 10 mL Ready-to-use Vial contains Esmolol Hydrochloride at a concentration of 10 milligrams/mL. When using a 10 milligrams/mL concentration, a loading dose of 0.5 mg/kg infused over 1 minute period of time, for a 70 kg patient is 3.5 mL.
The 5 mL DOUBLE STRENGTH Ready-to-use Vial contains Esmolol Hydrochloride at a concentration of 20 milligrams/mL. When using a 20 milligrams/mL concentration, a loading dose of 0.5 mg/kg infused over 1 minute period of time, for a 70 kg patient is 1.75 mL.
Directions for Use of the Brevibloc Concentrate 10 mL Ampul (250 milligrams/mL)
Dilution: Aseptically prepare a 10 mg/mL infusion by adding two 2500 mg ampuls to a 500 mL container or one 2500 mg ampul to a 250 mL container of a compatible intravenous solution listed below. (Remove overage prior to dilution as appropriate.) This yields a final concentration of 10 mg/mL. The diluted solution is stable for at least 24 hours at room temperature. Note: The use of esmolol with propylene glycol has been associated with a higher incidence of venous irritation at concentrations greater than 10 mg/mL on continued infusion. Mixed from the ampul at concentrations of greater than 10 mg/mL BREVIBLOC has, however, been well tolerated when administered via a central vein.
Compatibility with Commonly Used Intravenous Fluids
* Dextrose (5%) Injection, USP
BREVIBLOC is NOT compatible with Sodium Bicarbonate (5%) Injection, USP.
BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION
BREVIBLOC DOUBLE STRENGTH INJECTION
Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING. Avoid excessive heat.
Brevibloc (esmolol hydrochloride) and its packaging are protected by one or more of the following: U.S. Pat. Nos. 5,017,609; 5,849,843; 5,998,019; 6,310,094; 6,528,540; Pat. Pending.
For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)
Source: [package insert]