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DRUGS & SUPPLEMENTS
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Brevibloc Premixed
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Brevibloc Premixed uses
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
1 INDICATIONS AND USAGE
Brevibloc Premixed 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 Premixed (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 Premixed is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Brevibloc Premixed is intended for short-term use.
1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension
Brevibloc Premixed (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 Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed to alternative drugs, the physician should carefully consider the labeling instructions of the alternative drug selected and reduce the dosage of Brevibloc Premixed as follows:
- Thirty minutes following the first dose of the alternative drug, reduce the Brevibloc Premixed 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 Premixed infusion.
2.4 Directions for Use
Brevibloc Premixed injection is available in a pre-mixed bag and ready-to-use vial. Brevibloc Premixed 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 Premixed was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg Brevibloc Premixed hydrochloride per mL. Brevibloc Premixed 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
3 DOSAGE FORMS AND STRENGTHS
All Brevibloc Premixed dosage forms are iso-osmotic solutions of Brevibloc Premixed hydrochloride in sodium chloride.
| Product Name | Brevibloc Premixed PREMIXED Injection (Esmolol Hydrochloride) | Brevibloc Premixed DOUBLE STRENGTH PREMIXED Injection (Esmolol Hydrochloride) | Brevibloc Premixed Injection (Esmolol Hydrochloride) |
| Total Dose | 2500 mg / 250 mL | 2000 mg / 100 mL | 100 mg / 10 mL |
| Brevibloc Premixed 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)
4 CONTRAINDICATIONS
Brevibloc Premixed (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 Premixed in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving Brevibloc Premixed and intravenous verapamil.
- Pulmonary hypertension: May precipitate cardiorespiratory compromise.
- Hypersensitivity reactions, including anaphylaxis, to Brevibloc Premixed 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 Premixed injection (4, 7)
- Pulmonary hypertension (4)
- Known hypersensitivity to Brevibloc Premixed (4)
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 Premixed 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 Premixed 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 Premixed .
If severe bradycardia develops, reduce or stop Brevibloc Premixed.
5.3 Cardiac Failure
Beta blockers, like Brevibloc Premixed 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 Premixed and start supportive therapy .
5.4 Intraoperative and Postoperative Tachycardia and/or Hypertension
Monitor vital signs closely and titrate Brevibloc Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed may aggravate peripheral circulatory disorders.
5.12 Abrupt Discontinuation of Brevibloc Premixed 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 Premixed.
Heart rate increases moderately above pretreatment levels 30 minutes after Brevibloc Premixed discontinuation.
5.13 Hyperkalemia
Beta blockers, including Brevibloc Premixed, 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 Premixed.
5.14 Use in Patients with Metabolic Acidosis
Beta blockers, including Brevibloc Premixed, 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 .
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 Premixed (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 Premixed 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 Premixed (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 Premixed 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 Premixed 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 Premixed leads to an approximate 10% to 20% increase of digoxin blood levels at some time points. Digoxin does not affect Brevibloc Premixed pharmacokinetics. Both digoxin and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use increases the risk of bradycardia.
- Anticholinesterases: Brevibloc Premixed 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 Premixed 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 Premixed.
- Vasoconstrictive and positive inotropic agents: Because of the risk of reducing cardiac contractility in presence of high systemic vascular resistance, do not use Brevibloc Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed, 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 Premixed in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of Brevibloc Premixed 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 Premixed is metabolized by red-blood cell esterases .
8.7 Renal Impairment
No dosage adjustment is required for Brevibloc Premixed in patients with renal impairment receiving a maintenance infusion of Brevibloc Premixed 150 mcg/kg for 4 hours. There is no information on the tolerability of maintenance infusions of Brevibloc Premixed 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 Premixed 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 Premixed 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 Premixed have resulted from dilution errors. Use of Brevibloc Premixed PREMIXED Injection and Brevibloc Premixed 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 Premixed resolved.
11 DESCRIPTION
Brevibloc Premixed (Esmolol Hydrochloride) is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Brevibloc Premixed hydrochloride is:
- (±)-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnamate hydrochloride and has the following structure:
LOT
EXP
NDC 10019-075-87
Brevibloc Premixed
DOUBLE STRENGTH
Premixed Injection
Brevibloc Premixed 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 Premixed 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 Premixed DOUBLE STRENGTH
Premixed Injection
Brevibloc Premixed 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 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 Premixed
Injection
Brevibloc Premixed 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 Premixed
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 Premixed Injection
Brevibloc Premixed 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 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 Premixed
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 Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed 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 Premixed pharmaceutical active ingredients containing related brand and generic drugs:
Brevibloc Premixed available forms, composition, doses:
Brevibloc Premixed destination | category:
Brevibloc Premixed Anatomical Therapeutic Chemical codes:
Brevibloc Premixed pharmaceutical companies:
References
- Dailymed."BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- "ESMOLOL". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
- "ESMOLOL". http://www.drugbank.ca/drugs/DB0018... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Brevibloc Premixed?Depending on the reaction of the Brevibloc Premixed after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Brevibloc Premixed 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 Premixed 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.
Review
sdrugs.com conducted a study on Brevibloc Premixed, 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 Premixed 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.Visitor reports
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The information was verified by Dr. Rachana Salvi, MD Pharmacology