DRUGS & SUPPLEMENTS

Brevibloc

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Brevibloc uses


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
  • Control of perioperative tachycardia and hypertension (1.2)

1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia

Brevibloc (Esmolol Hydrochloride) 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 is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Brevibloc is intended for short-term use.

1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension

Brevibloc (Esmolol Hydrochloride) 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 to prevent such events is not recommended.

2 DOSAGE AND ADMINISTRATION

  • Administer intravenously
  • Titrate using ventricular rate or blood pressure at ≥4-minute intervals. (2.1, 2.2)
  • Supraventricular tachycardia (SVT) or noncompensatory sinus tachycardia (2.1)
    • Optional loading dose: 500 mcg per kg infused over one minute
    • Then 50 mcg per kg per minute for the next 4 minutes
    • Adjust dose as needed to a maximum of 200 mcg per kg per minute.
    • Additional loading doses may be administered
  • Perioperative tachycardia and hypertension (2.2)
    • Loading dose: 500 mcg per kg over 1 minute for gradual control (1 mg per kg over 30 seconds for immediate control)
    • Then 50 mcg per kg per min for gradual control (150 mcg per kg per minute for immediate control) adjusted to a maximum of 200 (tachycardia) or 300 (hypertension) mcg per kg per min (2.2)

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

Brevibloc 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.


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 Brevibloc 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

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

Gradual Control

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

Maximum Recommended Doses

  • 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.
  • For the treatment of hypertension, higher maintenance infusion dosages 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 to alternative drugs, the physician should carefully consider the labeling instructions of the alternative drug selected and reduce the dosage of Brevibloc as follows:

  • Thirty minutes following the first dose of the alternative drug, reduce the Brevibloc infusion rate by one-half (50%).
  • 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 is not compatible with Sodium Bicarbonate 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

  • The medication port is to be used solely for withdrawing an initial bolus from the bag.
  • Use aseptic technique when withdrawing the bolus dose.
  • Do not add any additional

Figure 1: Two-Port INTRAVIA Bag

Figure 1: Two-Port INTRAVIA Bag

  • medications to the bag.

Figure 1: Two-Port INTRAVIA 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.

Compatibility with Commonly Used Intravenous Fluids

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

  • Dextrose (5%) Injection, USP
  • Dextrose (5%) in Lactated Ringer’s Injection
  • Dextrose (5%) in Ringer’s Injection
  • Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP
  • Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
  • Lactated Ringer’s Injection, USP
  • Potassium Chloride (40 mEq/liter) in Dextrose (5%) Injection, USP
  • Sodium Chloride (0.45%) Injection, USP
  • Sodium Chloride (0.9%) Injection, USP
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3 DOSAGE FORMS AND STRENGTHS

All Brevibloc dosage forms are iso-osmotic solutions of Brevibloc hydrochloride in sodium chloride.


Product Name


Brevibloc

PREMIXED Injection

(Esmolol Hydrochloride)


Brevibloc

DOUBLE STRENGTH PREMIXED Injection

(Esmolol Hydrochloride)


Brevibloc Injection

(Esmolol Hydrochloride)


Total Dose


2500 mg / 250 mL


2000 mg / 100 mL


100 mg / 10 mL


Brevibloc Hydrochloride Concentration


10 mg/mL


20 mg/mL


10 mg/mL


Packaging


250 mL Bag


100 mL Bag


10 mL Vial

  • Injection: 100 mg/10 mL (10 mg/mL) in 10 mL vial (3)
  • Injection: 2500 mg/250 mL (10 mg/mL) in 250 mL Premixed Injection bag (3)
  • Injection: 2000 mg/100 mL (20 mg/mL) in 100 mL Double Strength Premixed Injection bag (3)
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4 CONTRAINDICATIONS

Brevibloc (Esmolol Hydrochloride) is contraindicated in patients with:

  • Severe sinus bradycardia: May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest .
  • Heart block greater than first degree: Second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest .
  • Sick sinus syndrome: May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest .
  • Decompensated heart failure: May worsen heart failure.
  • Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest.
  • IV administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and Brevibloc in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving Brevibloc and intravenous verapamil.
  • Pulmonary hypertension: May precipitate cardiorespiratory compromise.
  • Hypersensitivity reactions, including anaphylaxis, to Brevibloc or any of the inactive ingredients of the product (cross-sensitivity between beta blockers is possible).
  • Severe sinus bradycardia (4)
  • Heart block greater than first degree (4)
  • Sick sinus syndrome (4)
  • Decompensated heart failure (4)
  • Cardiogenic shock (4)
  • Coadministration of IV cardiodepressant calcium-channel antagonists (e.g. verapamil) in close proximity to Brevibloc injection (4, 7)
  • Pulmonary hypertension (4)
  • Known hypersensitivity to Brevibloc (4)
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5 WARNINGS AND PRECAUTIONS

  • Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use
  • Risk of exacerbating reactive airway disease (5.5)
  • Diabetes mellitus: Increases the effect of hypoglycemic agents and masks hypoglycemic tachycardia (5.6)
  • Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma (5.9)
  • Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease (5.12, 5.15)

5.1 Hypotension

Hypotension can occur at any dose but is dose-related. Patients with hemodynamic compromise or on interacting medications are at particular risk. Severe reactions may include loss of consciousness, cardiac arrest, and death. For control of ventricular heart rate, maintenance doses greater than 200 mcg per kg per min are not recommended. Monitor patients closely, especially if pretreatment blood pressure is low. In case of an unacceptable drop in blood pressure, reduce or stop Brevibloc injection. Decrease of dose or termination of infusion reverses hypotension, usually within 30 minutes.

5.2 Bradycardia

Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of Brevibloc injection. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Brevibloc .

If severe bradycardia develops, reduce or stop Brevibloc.

5.3 Cardiac Failure

Beta blockers, like Brevibloc injection, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. At the first sign or symptom of impending cardiac failure, stop Brevibloc and start supportive therapy .

5.4 Intraoperative and Postoperative Tachycardia and/or Hypertension

Monitor vital signs closely and titrate Brevibloc slowly in the treatment of patients whose blood pressure is primarily driven by vasoconstriction associated with hypothermia.

5.5 Reactive Airways Disease

Patients with reactive airways disease should, in general, not receive beta blockers. Because of its relative beta1 selectivity and titratability, titrate Brevibloc to the lowest possible effective dose. In the event of bronchospasm, stop the infusion immediately; a beta2 stimulating agent may be administered with appropriate monitoring of ventricular rates.

5.6 Use in Patients with Diabetes Mellitus and Hypoglycemia

In patients with hypoglycemia, or diabetic patients who are receiving insulin or other hypoglycemic agents, beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be masked.

Concomitant use of beta blockers and antidiabetic agents can enhance the effect of antidiabetic agents (blood glucose–lowering).

5.7 Infusion Site Reactions

Infusion site reactions have occurred with the use of Brevibloc injection. They include irritation, inflammation, and severe reactions (thrombophlebitis, necrosis, and blistering), in particular when associated with extravasation . Avoid infusions into small veins or through a butterfly catheter.

If a local infusion site reaction develops, use an alternative infusion site and avoid extravasation.

5.8 Use in Patients with Prinzmetal's Angina

Beta blockers may exacerbate anginal attacks in patients with Prinzmetal’s angina because of unopposed alpha receptor–mediated coronary artery vasoconstriction. Do not use nonselective beta blockers.

5.9 Use in Patients with Pheochromocytoma

If Brevibloc is used in the setting of pheochromocytoma, give it in combination with an alpha-blocker, and only after the alpha-blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure from the attenuation of beta-mediated vasodilation in skeletal muscle.

5.10 Use in Hypovolemic Patients

In hypovolemic patients, Brevibloc injection can attenuate reflex tachycardia and increase the risk of hypotension.

5.11 Use in Patients with Peripheral Circulatory Disorders

In patients with peripheral circulatory disorders, Brevibloc may aggravate peripheral circulatory disorders.

5.12 Abrupt Discontinuation of Brevibloc Injection

Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease upon abrupt discontinuation of beta blocker therapy. Observe patients for signs of myocardial ischemia when discontinuing Brevibloc.

Heart rate increases moderately above pretreatment levels 30 minutes after Brevibloc discontinuation.

5.13 Hyperkalemia

Beta blockers, including Brevibloc, have been associated with increases in serum potassium levels and hyperkalemia. The risk is increased in patients with risk factors such as renal impairment. Intravenous administration of beta blockers has been reported to cause potentially life-threatening hyperkalemia in hemodialysis patients. Monitor serum electrolytes during therapy with Brevibloc.

5.14 Use in Patients with Metabolic Acidosis

Beta blockers, including Brevibloc, have been reported to cause hyperkalemic renal tubular acidosis. Acidosis in general may be associated with reduced cardiac contractility.

5.15 Use in Patients with Hyperthyroidism

Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, monitor patients for signs of thyrotoxicosis when withdrawing beta blocking therapy.

5.16 Use in Patients at Risk of Severe Acute Hypersensitivity Reactions

When using beta blockers, patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic).

Patients using beta blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions .

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6 ADVERSE REACTIONS

Most common adverse reactions are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension (6)

To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 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, 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 following adverse reaction rates are based on use of Brevibloc (Esmolol Hydrochloride) in clinical trials involving 369 patients with supraventricular tachycardia and over 600 intraoperative and postoperative patients enrolled in clinical trials. Most adverse effects observed in controlled clinical trial settings have been mild and transient. The most important and common adverse effect has been hypotension . Deaths have been reported in post-marketing experience occurring during complex clinical states where Brevibloc was presumably being used simply to control ventricular rate .


System Organ Class (SOC)


Preferred MedDRA Term


Frequency


VASCULAR DISORDERS


Hypotension*


Asymptomatic hypotension


25%


Symptomatic hypotension

(hyperhidrosis, dizziness)


12%


GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS


Infusion site reactions

(inflammation and induration)


8%


GASTROINTESTINAL DISORDERS


Nausea


7%


NERVOUS SYSTEM DISORDERS


Dizziness


3%


Somnolence


3%


* Hypotension resolved during Brevibloc (Esmolol Hydrochloride) infusion in 63% of patients. In 80% of the remaining patients, hypotension resolved within 30 minutes following discontinuation of infusion.

Clinical Trial Adverse Reactions

Psychiatric Disorders

Confusional state and agitation (~2%)

Anxiety, depression and abnormal thinking (<1%)

Nervous System Disorders

Headache (~ 2%)

Paresthesia, syncope, speech disorder, and lightheadedness (<1%)

Convulsions (<1%), with one death

Vascular Disorders

Peripheral ischemia (~1%)

Pallor and flushing (<1%)

Gastrointestinal Disorders

Vomiting (~1%)

Dyspepsia, constipation, dry mouth, and abdominal discomfort (<1%)

Renal and Urinary Disorders

Urinary retention (<1%)

6.2 Post-Marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been reported in the post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.

Cardiac Disorders

Cardiac arrest, Coronary arteriospasm

Skin and Subcutaneous Tissue Disorders

Angioedema, Urticaria, Psoriasis

7 DRUG INTERACTIONS

Concomitant use of Brevibloc injection with other drugs that can lower blood pressure, reduce myocardial contractility, or interfere with sinus node function or electrical impulse propagation in the myocardium can exaggerate BREVIBLOC’s effects on blood pressure, contractility, and impulse propagation. Severe interactions with such drugs can result in, for example, severe hypotension, cardiac failure, severe bradycardia, sinus pause, sinoatrial block, atrioventricular block, and/or cardiac arrest. In addition, with some drugs, beta blockade may precipitate increased withdrawal effects. Brevibloc should therefore be used only after careful individual assessment of the risks and expected benefits in patients receiving drugs that can cause these types of pharmacodynamic interactions, including but not limited to:

  • Digitalis glycosides: Concomitant administration of digoxin and Brevibloc leads to an approximate 10% to 20% increase of digoxin blood levels at some time points. Digoxin does not affect Brevibloc pharmacokinetics. Both digoxin and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use increases the risk of bradycardia.
  • Anticholinesterases: Brevibloc prolonged the duration of succinylcholine-induced neuromuscular blockade and moderately prolonged clinical duration and recovery index of mivacurium.
  • Antihypertensive agents clonidine, guanfacine, or moxonidine: Beta blockers also increase the risk of clonidine-, guanfacine-, or moxonidine-withdrawal rebound hypertension. If, during concomitant use of a beta blocker, antihypertensive therapy needs to be interrupted or discontinued, discontinue the beta blocker first, and the discontinuation should be gradual.
  • Calcium channel antagonists: In patients with depressed myocardial function, use of Brevibloc with cardiodepressant calcium channel antagonists (e.g., verapamil) can lead to fatal cardiac arrests.
  • Sympathomimetic drugs: Sympathomimetic drugs having beta-adrenergic agonist activity will counteract effects of Brevibloc.
  • Vasoconstrictive and positive inotropic agents: Because of the risk of reducing cardiac contractility in presence of high systemic vascular resistance, do not use Brevibloc to control tachycardia in patients receiving drugs that are vasoconstrictive and have positive inotropic effects, such as epinephrine, norepinephrine, and dopamine.
  • Digitalis glycosides: Risk of bradycardia (7)
  • Anticholinesterases: Prolongs neuromuscular blockade (7)
  • Antihypertensive agents: Risk of rebound hypertension (7)
  • Sympathomimetic drugs: Dose adjustment needed (7)
  • Vasoconstrictive and positive inotropic effect substances: Avoid concomitant use (7)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Brevibloc hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose. There are no adequate and well-controlled studies in pregnant women. Brevibloc injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Teratogenicity studies in rats at intravenous dosages of Brevibloc hydrochloride up to 3000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. In rabbits, intravenous dosages up to 1000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions.

8.2 Labor and Delivery

Although there are no adequate and well-controlled studies in pregnant women, use of Brevibloc in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. Brevibloc injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Brevibloc, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and effectiveness of Brevibloc in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Brevibloc injection did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy.

8.6 Hepatic Impairment

No special precautions are necessary in patients with hepatic impairment because Brevibloc is metabolized by red-blood cell esterases .

8.7 Renal Impairment

No dosage adjustment is required for Brevibloc in patients with renal impairment receiving a maintenance infusion of Brevibloc 150 mcg/kg for 4 hours. There is no information on the tolerability of maintenance infusions of Brevibloc using rates in excess of 150 mcg/kg or maintained longer than 4 hours.

10 OVERDOSAGE

10.1 Signs and Symptoms of Overdose

Overdoses of Brevibloc can cause cardiac and central nervous system effects. These effects may precipitate severe signs, symptoms, sequelae, and complications (for example, severe cardiac and respiratory failure, including shock and coma), and may be fatal. Continuous monitoring of the patient is required.

  • Cardiac effects include bradycardia, atrioventricular block (1st -, 2nd -, 3rd degree), junctional rhythms, intraventricular conduction delays, decreased cardiac contractility, hypotension, cardiac failure (including cardiogenic shock), cardiac arrest/asystole, and pulseless electrical activity.
  • Central nervous system effects include respiratory depression, seizures, sleep and mood disturbances, fatigue, lethargy, and coma.
  • In addition, bronchospasm, mesenteric ischemia, peripheral cyanosis, hyperkalemia, and hypoglycemia (especially in children) may occur.

10.2 Treatment Recommendations

Because of its approximately 9-minute elimination half-life, the first step in the management of toxicity should be to discontinue the Brevibloc infusion. Then, based on the observed clinical effects, consider the following general measures.

Bradycardia

Consider intravenous administration of atropine or another anticholinergic drug or cardiac pacing.

Cardiac Failure

Consider intravenous administration of a diuretic or digitalis glycoside. In shock resulting from inadequate cardiac contractility, consider intravenous administration of dopamine, dobutamine, isoproterenol, or inamrinone. Glucagon has been reported to be useful.

Symptomatic hypotension

Consider intravenous administration of fluids or vasopressor agents such as dopamine or norepinephrine.

Bronchospasm

Consider intravenous administration of a beta2 stimulating agent or a theophylline derivative.

10.3 Dilution Errors

Massive accidental overdoses of Brevibloc have resulted from dilution errors. Use of Brevibloc PREMIXED Injection and Brevibloc DOUBLE STRENGTH PREMIXED Injection may reduce the potential for dilution errors. Some of these overdoses have been fatal while others resulted in permanent disability. Bolus doses in the range of 625 mg to 2.5 g (12.5-50 mg/kg) have been fatal. Patients have recovered completely from overdoses as high as 1.75 g given over one minute or doses of 7.5 g given over one hour for cardiovascular surgery. The patients who survived appear to be those whose circulation could be supported until the effects of Brevibloc resolved.

11 DESCRIPTION

Brevibloc (Esmolol Hydrochloride) is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Brevibloc hydrochloride is:

  • (±)-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnamate hydrochloride and has the following structure:

LOT

EXP

NDC 10019-075-87

Brevibloc

DOUBLE STRENGTH

Premixed Injection

Brevibloc Hydrochloride in Sodium Chloride

2,000 mg/100 mL (20 mg/mL)

100 mL Iso-Osmotic - No Preservative Added

Single Intravenous Use Only

EACH mL CONTAINS 20 mg Brevibloc HYDROCHLORIDE

USP 4.1 mg SODIUM CHLORIDE USP IN WATER

FOR INJECTION USP BUFFERED WITH 2.8 mg SODIUM

ACETATE TRIHYDRATE USP AND 0.546 mg GLACIAL

ACETIC ACID USP pH ADJUSTED WITH SODIUM

HYDROXIDE AND/OR HYDROCHLORIC ACID pH 5.0

(4.5-5.5) STERILE NONPYROGENIC

USUAL DOSAGE SEE PACKAGE INSERT

CAUTIONS CHECK FOR LEAKS BY SQUEEZING

CONTAINER FIRMLY IF LEAKS ARE FOUND DISCARD AS

STERILITY MAY BE IMPAIRED USE ONLY IF SOLUTION IS

CLEAR COLORLESS TO LIGHT YELLOW

DISCARD UNUSED PORTION

DO NOT INTRODUCE ADDITIVES

MUST NOT BE USED IN SERIES CONNECTIONS

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 Rx only

Baxter

DEERFIELD, IL 60015 USA

MADE IN USA

460-324-01 2J1413

10 x 100 mL Single Use

INTRAVIA containers

NDC 10019-075-87

Brevibloc DOUBLE STRENGTH

Premixed Injection

Brevibloc Hydrochloride in Sodium Chloride 2,000 mg/100 mL (20 mg/mL)

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.

2D DATA

MATRIX

BAR CODE

PLACEMENT

ONLY

Baxter, Brevibloc Premixed and IntraVia are

trademarks of Baxter International Inc.

(01)50310019075872

(21)NNNNNNNNN

(17)YYMMDD

(10)XXXXXXX

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

475-345-00 07-06-35-706

EXP

LOT

Rx only

Code 2J1413

For Product Inquiry

1 800 ANA DRUG

(1-800-262-3784)

BARCODE PLACEMENT ONLY

(01)50310019075872(21)NNNNNNNNNNNNNNNNNNNN(17)YYMMMDD(10) XXXXXXXXX

LOT EXP

NDC 10019-055-61

Brevibloc Premixed

Injection

Brevibloc Hydrochloride

in Sodium Chloride

2,500 mg/250 mL (10 mg/mL)

250 mL Iso-Osmotic

No Preservative Added

Single Intravenous Use Only

EACH mL CONTAINS 10 mg Brevibloc

HYDROCHLORIDE USP 5.9 mg SODIUM

CHLORIDE USP IN WATER FOR INJECTION

USP BUFFERED WITH 2.8 mg SODIUM

ACETATE TRIHYDRATE USP AND 0.546 mg GLACIAL ACETIC ACID USP

pH ADJUSTED WITH SODIUM HYDROXIDE AND/OR HYDROCHLORIC ACID

pH 5.0 (4.5-5.5) STERILE NONPYROGENIC

USUAL DOSAGE SEE PACKAGE INSERT

CAUTIONS CHECK FOR LEAKS BY SQUEEZING CONTAINER FIRMLY

IF LEAKS ARE FOUND DISCARD AS STERILITY MAY BE IMPAIRED USE

ONLY IF SOLUTION IS CLEAR COLORLESS TO LIGHT YELLOW DISCARD

UNUSED PORTION

DO NOT INTRODUCE ADDITIVES

MUST NOT BE USED IN SERIES CONNECTIONS

STORE AT 25°C (77°F) EXCURSIONS PERMITTED TO 15°-30°C

(59°-86°F)

PROTECT FROM FREEZING AVOID EXCESSIVE HEAT Rx only

Baxter

BAXTER HEALTHCARE CORPORATION

DEERFIELD, IL 60015 USA

MADE IN USA

INTRAVIA CONTAINER

460-327-02 2J1415

FOR PRODUCT INQUIRY

1 800 ANA DRUG

(1-800-262-3784)

10 x 250 mL Single Use

INTRAVIA containers

NDC 10019-055-61

Brevibloc Premixed Injection

Brevibloc Hydrochloride in Sodium Chloride

2,500 mg/250 mL (10 mg/mL)

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.

2D DATA

MATRIX

BAR CODE

PLACEMENT

ONLY

Baxter, Brevibloc Premixed and IntraVia are

trademarks of Baxter International Inc.

(01)50310019055614

(21)NNNNNNNNN

(17)YYMMDD

(10)XXXXXXX

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

475-344-00 07-06-75-367

EXP

LOT

Rx only

Code 2J1415

For Product Inquiry

1 800 ANA DRUG

(1-800-262-3784)

BAR CODE PLACEMENT ONLY

(01)50310019055614(21)NNNNNNNNNNNNNNNNNNNN(17)YYMMDD(10)XXXXXXXXX

NDC 10019-115-39

Brevibloc

Injection

(Esmolol Hydrochloride)

100 mg/10 mL

(10 mg/mL)

10 mL

Rx only

Ready-to-use Vial

FOR INTRAVENOUS USE

Iso-Osmotic

Contains no

preservatives-

discard unused portion.

For Product Inquiry

1 800 ANA DRUG (1-800-262-3784)

Mfd. for Baxter Healthcare Corp.

Deerfield, IL 60015 USA

462-405-01

LOT:

EXP.:

NDC 10019-115-01

Brevibloc Injection

(Esmolol Hydrochloride)

100 mg/10 mL (10 mg/mL)

25 x 10 mL Rx only

Ready-to-use Vials

FOR INTRAVENOUS USE

Baxter

Manufactured for

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

NDC 10019-115-01

Brevibloc Injection (Esmolol Hydrochloride)

100 mg/10 mL (10 mg/mL)

25 x 10 mL Ready-to-use Vials

FOR INTRAVENOUS USE

Rx only

Single Dose Vials

Iso-Osmotic

Contains no preservatives -

discard unused portion.

Baxter

Manufactured for

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

NDC 10019-115-01

Brevibloc Injection (Esmolol Hydrochloride)

100 mg/10 mL (10 mg/mL)

25 x 10 mL Ready-to-use Vials

FOR INTRAVENOUS USE

Rx only

Single Dose Vials

Iso-Osmotic

Contains no preservatives -

discard unused portion.

Baxter

Manufactured for

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

NDC 10019-115-01

Brevibloc Injection (Esmolol Hydrochloride)

100 mg/10 mL (10 mg/mL)

25 x 10 mL Ready-to-use Vials

FOR INTRAVENOUS USE

Rx only

Single Dose Vials

Iso-Osmotic

Contains no preservatives -

discard unused portion.

Baxter

Manufactured for

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

40602

Each mL contains: 10 mg Brevibloc Hydrochloride,

USP and 5.9 mg Sodium Chloride, USP in Water

for Injection, USP. Buffered with Sodium Acetate

Trihydrate, USP and Glacial Acetic Acid, USP.

Sodium Hydroxide and/or Hydrochloric Acid added

to adjust pH to 5.0 (range 4.5-5.5).

Store at 25°C (77°F). Excursions permitted to

15°-30°C (59°-86°F). [See USP Controlled Room

Temperature.] Avoid contact with alkalies. Do not

use if discolored or if a precipitate is present.

See package insert for complete information on

dosage and administration.

For Product Inquiry 1 800 ANA DRUG

(1-800-262-3784)

462-406-02 07-03-73-098

N

3 10019 11501 6

LOT:

EXP:

40601

Brevibloc pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Brevibloc available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Brevibloc destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Brevibloc Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Brevibloc pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "ESMOLOL". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "ESMOLOL". http://www.drugbank.ca/drugs/DB0018... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Brevibloc?

Depending on the reaction of the Brevibloc after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Brevibloc not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Brevibloc addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Brevibloc, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Brevibloc consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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