DRUGS & SUPPLEMENTS

Bromurex

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Bromurex uses


INDICATIONS AND USAGE

Bromurex is indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

CONTRAINDICATIONS

Bromurex Injection, USP is contraindicated in patients known to be hypersensitive to the drug.

WARNINGS

Bromurex INJECTION, USP SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSES BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND THE POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS FACILITIES FOR INTUBATION, ARTIFICIAL RESPIRATION, OXYGEN THERAPY, AND REVERSAL AGENTS ARE IMMEDIATELY AVAILABLE. THE CLINICIAN MUST BE PREPARED TO ASSIST OR CONTROL RESPIRATION.

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including Bromurex, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs.

In patients who are known to have myasthenia gravis or the myasthenic (Eaton-Lambert) syndrome, small doses of Bromurex may have profound effects. In such patients, a peripheral nerve stimulator and use of a small test dose may be of value in monitoring the response to administration of muscle relaxants.

Benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants.

Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to those received in flush solutions containing benzyl alcohol. Administration of high dosages of medications (including pancuronium) containing this preservative must take into account the total amount of benzyl alcohol administered. The recommended dosage range of Bromurex for preterm and term infants includes amounts of benzyl alcohol well below that associated with toxicity; however, the amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources.

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PRECAUTIONS

USE OF A PERIPHERAL NERVE STIMULATOR WILL USUALLY BE OF VALUE FOR MONITORING OF NEUROMUSCULAR BLOCKING EFFECT, AVOIDING OVERDOSAGE AND ASSISTING IN EVALUATION OF RECOVERY.

General

Although Bromurex Injection, USP has been used successfully in many patients with pre-existing pulmonary, hepatic, or renal disease, caution should be exercised in these situations.

Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents. In addition, inform your patients that severe anaphylactic reactions to neuromuscular blocking agents, including Bromurex have been reported.

Renal Failure

A major portion of pancuronium, as well as an active metabolite, are recovered in urine. The elimination half-life is doubled and the plasma clearance is reduced in patients with renal failure; at the same time, the rate of recovery of neuromuscular blockade is variable and sometimes very much slower than normal. This information should be taken into consideration if pancuronium is selected, for other reasons, to be used in a patient with renal failure.

Altered Circulation Time

Conditions associated with slower circulation time in cardiovascular disease, old age, edematous states resulting in increased volume of distribution may contribute to a delay in onset time; therefore, dosage should not be increased.

Hepatic and/or Biliary Tract Disease

The doubled elimination half-life and reduced plasma clearance determined in patients with hepatic and/or biliary tract disease, as well as limited data showing that recovery time is prolonged an average of 65% in patients with biliary tract obstruction, suggests that prolongation of neuromuscular blockade may occur. At the same time, these conditions are characterized by an approximately 50% increase in volume of distribution of pancuronium, suggesting that the total initial dose to achieve adequate relaxation may in some cases be high. The possibility of slower onset, higher total dosage and prolongation of neuromuscular blockade must be taken into consideration when pancuronium is used in these patients..

Long-term Use in I.C.U.

In the intensive care unit, in rare cases, long-term use of neuromuscular blocking drugs to facilitate mechanical ventilation may be associated with prolonged paralysis and/or skeletal muscle weakness that may be first noted during attempts to wean such patients from the ventilator. Typically, such patients receive other drugs such as broad spectrum antibiotics, narcotics and/or steroids and may have electrolyte imbalance and diseases which lead to electrolyte imbalance, hypoxic episodes of varying duration, acid-base imbalance, and extreme debilitation, any of which may enhance the actions of a neuromuscular blocking agent. Additionally, patients immobilized for extended periods frequently develop symptoms consistent with disuse muscle atrophy. Therefore, when there is a need for long-term mechanical ventilation, the benefits-to-risk ratio of neuromuscular blockade must be considered.

Continuous infusion or intermittent bolus dosing to support mechanical ventilation has not been studied sufficiently to support dosage recommendations.

UNDER THE ABOVE CONDITIONS, APPROPRIATE MONITORING, SUCH AS USE OF A PERIPHERAL NERVE STIMULATOR, TO ASSESS THE DEGREE OF NEUROMUSCULAR BLOCKADE, MAY PRECLUDE INADVERTENT EXCESS DOSING.

Severe Obesity or Neuromuscular Disease

Patients with severe obesity or neuromuscular disease may pose airway and/or ventilatory problems requiring special care before, during, and after the use of neuromuscular blocking agents such as Bromurex.

CNS

Bromurex has no known effect on consciousness, the pain threshold or cerebration. Administration should be accompanied by adequate anesthesia or sedation.

Drug Interactions

Prior administration of succinylcholine may enhance the neuromuscular blocking effect of pancuronium and increase its duration of action. If succinylcholine is used before Bromurex, the administration of Bromurex should be delayed until the patient starts recovering from succinylcholine-induced neuromuscular blockade.

If a small dose of Bromurex is given at least 3 minutes prior to the administration of succinylcholine, in order to reduce the incidence and intensity of succinylcholine-induced fasciculations, this dose may induce a degree of neuromuscular block sufficient to cause respiratory depression in some patients.

Other nondepolarizing neuromuscular blocking agents behave in a clinically similar fashion to Bromurex. The combination of pancuronium bromide-metocurine and pancuronium bromide-d-tubocurarine are significantly more potent than the additive effects of each of the individual drugs given alone, however, the duration of blockade of these combinations is not prolonged. There are insufficient data to support concomitant use of pancuronium and the other three above mentioned muscle relaxants in the same patient.

Inhalational Anesthetics

Use of volatile inhalational anesthetics such as enflurane, isoflurane, and halothane with Bromurex will enhance neuromuscular blockade. Potentiation is most prominent with use of enflurane and isoflurane.

With the above agents, the intubating dose of Bromurex may be the same as with balanced anesthesia unless the inhalational anesthetic has been administered for a sufficient time at a sufficient dose to have reached clinical equilibrium. The relatively long duration of action of pancuronium should be taken into consideration when the drug is selected for intubation in these circumstances.

Clinical experience and animal experiments suggest that pancuronium should be given with caution to patients receiving chronic tricyclic antidepressant therapy who are anesthetized with halothane because severe ventricular arrhythmias may result from this combination. The severity of the arrhythmias appear in part related to the dose of pancuronium.

Antibiotics

Parenteral/intraperitoneal administration of high doses of certain antibiotics may intensify or produce neuromuscular block on their own. The following antibiotics have been associated with various degrees of paralysis: aminoglycosides ; tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. If these or other newly introduced antibiotics are used preoperatively or in conjunction with Bromurex, unexpected prolongation of neuromuscular block should be considered a possibility.

Other

Experience concerning injection of quinidine during recovery from use of other muscle relaxants suggests that recurrent paralysis may occur. This possibility must also be considered for Bromurex.

Electrolyte imbalance and diseases which lead to electrolyte imbalance, such as adrenal cortical insufficiency, have been shown to alter neuromuscular blockade. Depending on the nature of the imbalance, either enhancement or inhibition may be expected. Magnesium salts, administered for the management of toxemia of pregnancy, may enhance the neuromuscular blockade.

Drug/Laboratory Test Interactions

None known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been performed. It is not known whether Bromurex can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bromurex should be given to a pregnant woman only if the administering clinician decides that the benefits outweigh the risks.

Bromurex may be used in operative obstetrics, but reversal of pancuronium may be unsatisfactory in patients receiving magnesium sulfate for toxemia of pregnancy because magnesium salts enhance neuromuscular blockade. Dosage should usually be reduced, as indicated, in such cases. It is also recommended that the interval between use of pancuronium and delivery be reasonably short to avoid clinically significant placental transfer.

Pediatric Use

Dose response studies in children indicate that, with the exception of neonates, dosage requirements are the same as for adults. Neonates are especially sensitive to nondepolarizing neuromuscular blocking agents, such as Bromurex, during the first month of life. It is recommended that a test dose of 0.02 mg/kg be given first in this group to measure responsiveness.

The prolonged use of Bromurex for the management of neonates undergoing mechanical ventilation has been associated in rare cases with severe skeletal muscle weakness that may first be noted during attempts to wean such patients from the ventilator; such patients usually receive other drugs such as antibiotics which may enhance neuromuscular blockade. Microscopic changes consistent with disuse atrophy have been noted at autopsy. Although a cause-and-effect relationship has not been established, the benefits-to-risk ratio must be considered when there is a need for neuromuscular blockade to facilitate long-term mechanical ventilation of neonates.

Rare cases of unexplained, clinically significant methemoglobinemia have been reported in premature neonates undergoing emergency anesthesia and surgery which included combined use of pancuronium, fentanyl and atropine. A direct cause-and-effect relationship between the combined use of these drugs and the reported cases of methemoglobinemia has not been established.

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ADVERSE REACTIONS

Neuromuscular

The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the drug's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnea..

Inadequate reversal of the neuromuscular blockade is possible with Bromurex as with all curariform drugs. These adverse experiences are managed by manual or mechanical ventilation until recovery is judged adequate.

Prolonged paralysis and/or skeletal muscle weakness have been reported after long-term use to support mechanical ventilation in the intensive care unit.

Cardiovascular

See discussion of circulatory effects in CLINICAL PHARMACOLOGY .

Gastrointestinal

Salivation is sometimes noted during very light anesthesia, especially if no anticholinergic premedication is used.

Skin

An occasional transient rash is noted accompanying the use of Bromurex.

Other

Although histamine release is not a characteristic action of Bromurex, rare hypersensitivity reactions such as bronchospasm, flushing, redness, hypotension, tachycardia and other reactions possibly mediated by histamine release have been reported.

There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including Bromurex. These reactions, in some cases, have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS ).

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OVERDOSAGE

The possibility of iatrogenic overdosage can be minimized by carefully monitoring the muscle twitch response to peripheral nerve stimulation.

Excessive doses of Bromurex can be expected to produce enhanced pharmacological effects. Residual neuromuscular blockade beyond the time period needed may occur with Bromurex as with other neuromuscular blockers. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. A peripheral nerve stimulator may be used to assess the degree of residual neuromuscular blockade and help to differentiate residual neuromuscular blockade from other causes of decreased respiratory reserve.

Pyridostigmine bromide, neostigmine, or edrophonium, in conjunction with atropine or glycopyrrolate, will usually antagonize the skeletal muscle relaxant action of Bromurex. Satisfactory reversal can be judged by adequacy of skeletal muscle tone and by adequacy of respiration. A peripheral nerve stimulator may also be used to monitor restoration of twitch response.

Failure of prompt reversal (within 30 minutes) may occur in the presence of extreme debilitation, carcinomatosis, and with concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular blockade or cause respiratory depression of their own. Under such circumstances, the management is the same as that of prolonged neuromuscular blockade. Ventilation must be supported by artificial means until the patient has resumed control of his respiration. Prior to the use of reversal agents, reference should be made to the specific package insert of the reversal agent.

DOSAGE AND ADMINISTRATION

Bromurex Injection, USP is for intravenous use only. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of neuromuscular blocking agents. DOSAGE MUST BE INDIVIDUALIZED IN EACH CASE. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only. Since potent inhalational anesthetics or prior use of succinylcholine may enhance the intensity and duration of Bromurex, the lower end of the recommended initial dosage range may suffice when Bromurex is first used after intubation with succinylcholine and/or after maintenance doses of volatile liquid inhalational anesthetics are started. To obtain maximum clinical benefits of Bromurex Injection, USP and to minimize the possibility of overdosage, the monitoring of muscle twitch response to a peripheral nerve stimulator is advised.

In adults under balanced anesthesia the initial intravenous dosage range is 0.04 to 0.1 mg/kg. Later incremental doses starting at 0.01 mg/kg may be used. These increments slightly increase the magnitude of the blockade and significantly increase the duration of blockade because a significant number of myoneural junctions are still blocked when there is clinical need for more drug.

If Bromurex Injection, USP is used to provide skeletal muscle relaxation for endotracheal intubation, a bolus dose of 0.06 to 0.1 mg/kg is recommended. Conditions satisfactory for intubation are usually present within 2 to 3 minutes (see PRECAUTIONS ).

Dosage in Children

Dose response studies in children indicate that, with the exception of neonates, dosage requirements are the same as for adults. Neonates are especially sensitive to nondepolarizing neuromuscular blocking agents, such as Bromurex Injection, USP, during the first month of life. It is recommended that a test dose of 0.02 mg/kg be given first in this group to measure responsiveness.

Caesarean Section

The dosage to provide relaxation for intubation and operation is the same as for general surgical procedures. The dosage to provide relaxation, following usage of succinylcholine for intubation, is the same as for general surgical procedures.

Compatibility

Bromurex Injection, USP is compatible in solution with:

0.9% sodium chloride injection

5% dextrose injection

5% dextrose and sodium chloride injection

Lactated Ringer's injection

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

When mixed with the above solutions in glass or plastic containers, Bromurex Injection, USP will remain stable in solution for 48 hours with no alteration in potency or pH; no decomposition is observed and there is no absorption to either the glass or plastic container.

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HOW SUPPLIED

Bromurex Injection, USP is supplied as follows:

NDC No. Container
0409-4646-01 Multiple-dose 10 mL Fliptop Vial-10 mg/10 mL

tray of 25

STORAGE

Store in refrigerator 2° to 8°C (36° to 46°F).

The 10 mL vial will maintain full clinical potency for up to six months at room temperature.

Hospira, Inc., Lake Forest, IL 60045 USA

EN-3390

11/2013

Logo

10 mL Multiple-dose

Rx only

Bromurex

Injection, USP

10 mg/10 mL (1 mg/mL)

FOR INTRAVENOUS USE.

Hospira, Inc., Lake Forest, IL 60045 USA

Bromurex 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.


Bromurex 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.


Bromurex 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.


Bromurex 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.


Bromurex 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."PANCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "pancuronium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Pancuronium". http://www.drugbank.ca/drugs/DB0133... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Bromurex?

Depending on the reaction of the Bromurex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Bromurex 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 Bromurex 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 Bromurex, 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 Bromurex 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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