Brevibloc

BREVIBLOC- esmolol hydrochloride injection
Baxter Healthcare Corporation

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing for the Treatment of Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia

BREVIBLOC injection is administered by continuous intravenous infusion with or without a loading dose. Additional loading doses and/or titration of the maintenance infusion (step-wise dosing) may be necessary based on desired ventricular response.

Table 1 Step-Wise Dosing

Step	Action
1	Optional loading dose (500 mcg per kg over 1 minute), then 50 mcg per kg per min for 4 min
2	Optional loading dose if necessary, then 100 mcg per kg per min for 4 min
3	Optional loading dose if necessary, then 150 mcg per kg per min for 4 min
4	If necessary, increase dose to 200 mcg per kg per min

In the absence of loading doses, continuous infusion of a single concentration of esmolol reaches pharmacokinetic and pharmacodynamic steady-state in about 30 minutes.

The effective maintenance dose for continuous and step-wise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate. Dosages greater than 200 mcg per kg per minute provide little added heart rate lowering effect, and the rate of adverse reactions increases.

Maintenance infusions may be continued for up to 48 hours.

2.2 Intraoperative and Postoperative Tachycardia and Hypertension

In this setting it is not always advisable to slowly titrate to a therapeutic effect. Therefore two dosing options are presented: immediate control and gradual control.

Immediate Control

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Administer 1 mg per kg as a bolus dose over 30 seconds followed by an infusion of 150 mcg per kg per min if necessary.

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Adjust the infusion rate as required to maintain desired heart rate and blood pressure. Refer to Maximum Recommended Doses below.

Gradual Control

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Administer 500 mcg per kg as a bolus dose over 1 minute followed by a maintenance infusion of 50 mcg per kg per min for 4 minutes.

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Depending on the response obtained, continue dosing as outlined for supraventricular tachycardia. Refer to Maximum Recommended Doses below.

Maximum Recommended Doses

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For the treatment of tachycardia, maintenance infusion dosages greater than 200 mcg per kg per min are not recommended; dosages greater than 200 mcg per kg per min provide little additional heart rate-lowering effect, and the rate of adverse reactions increases.

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For the treatment of hypertension, higher maintenance infusion dosages (250-300 mcg per kg per min) may be required. The safety of doses above 300 mcg per kg per minute has not been studied.

2.3 Transition from BREVIBLOC Injection Therapy to Alternative Drugs

After patients achieve adequate control of the heart rate and a stable clinical status, transition to alternative antiarrhythmic drugs may be accomplished.

When transitioning from BREVIBLOC injection to alternative drugs, the physician should carefully consider the labeling instructions of the alternative drug selected and reduce the dosage of BREVIBLOC injection as follows:

1.

Thirty minutes following the first dose of the alternative drug, reduce the BREVIBLOC infusion rate by one-half (50%).

2.

After administration of the second dose of the alternative drug, monitor the patient’s response and if satisfactory control is maintained for the first hour, discontinue the BREVIBLOC infusion.

2.4 Directions for Use

BREVIBLOC injection is available in a pre-mixed bag and ready-to-use vial. BREVIBLOC injection is not compatible with Sodium Bicarbonate (5%) solution (limited stability) or furosemide (precipitation).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Premixed Bag

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The medication port is to be used solely for withdrawing an initial bolus from the bag.

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Use aseptic technique when withdrawing the bolus dose.

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Do not add any additional medications to the bag.

Figure 1: Two-Port INTRAVIA Bag

Ready-to-Use Vial

The Ready-to-use Vial may be used to administer a loading dosage by hand-held syringe while the maintenance infusion is being prepared [see How Supplied/Storage and Handling (16.2)].

Compatibility with Commonly Used Intravenous Fluids

BREVIBLOC injection was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg esmolol hydrochloride per mL. BREVIBLOC injection was found to be compatible with the following solutions and was stable for at least 24 hours at controlled room temperature or under refrigeration:

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Dextrose (5%) Injection, USP

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Dextrose (5%) in Lactated Ringer’s Injection

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Dextrose (5%) in Ringer’s Injection

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Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP

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Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP

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Lactated Ringer’s Injection, USP

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Potassium Chloride (40 mEq/liter) in Dextrose (5%) Injection, USP

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Sodium Chloride (0.45%) Injection, USP

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Sodium Chloride (0.9%) Injection, USP