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Zemuron organon

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Depolarizing NMBAs ie, succinylcholine are not reversed by these agents and their toxicity may be worsened by concomitant administration. Merck formerly Schering-Plough , Customer Service personal communications.

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Zemuron rocuronium bromide Injection product label. Roseland, NJ; Organon; November Anesthesiology and Critical Care Drug Handbook. Hudson, OH: Lexi-Comp; Muscle Relaxants - Adjuncts to Anesthesia. In: Wickersham, R. Drug Facts and Comparisons eFacts. Neuromuscular Blocking Agents. Protecting your personal information is important.

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Magnesium salts administered for the management of toxemia of pregnancy may enhance neuromuscular blockade [see Warnings and Precautions 5. There are no controlled studies documenting the use of Zemuron before or after other nondepolarizing muscle relaxants.

Interactions have been observed when other nondepolarizing muscle relaxants have been administered in succession. Procainamide has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions 5.

The use of propofol for induction and maintenance of anesthesia does not alter the clinical duration or recovery characteristics following recommended doses of Zemuron. Injection of quinidine during recovery from use of muscle relaxants is associated with recurrent paralysis. This possibility must also be considered for Zemuron [see Warnings and Precautions 5. The use of Zemuron before succinylcholine, for the purpose of attenuating some of the side effects of succinylcholine, has not been studied.

If Zemuron is administered following administration of succinylcholine, it should not be given until recovery from succinylcholine has been observed. The median duration of action of Zemuron 0. Pregnancy Category C: Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.

Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats 0. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug. Teratogenicity was not observed in these animal species.

The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.

However, there are no adequate and well-controlled studies in pregnant women. Zemuron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The use of Zemuron in Cesarean section has been studied in a limited number of patients [see Clinical Studies Zemuron is not recommended for rapid sequence induction in Cesarean section patients. The use of Zemuron has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia.

One of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [see Dosage and Administration 2. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of Zemuron with general anesthetic agents can prolong the QTc interval.

The data also suggest that Zemuron may increase heart rate. However, it was not possible to conclusively identify an effect of Zemuron independent of that of anesthesia and other factors. Additionally, when examining plasma levels of Zemuron in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration 2.

Zemuron is not recommended for rapid sequence intubation in pediatric patients. Recommendations for use in pediatric patients are discussed in other sections [see Dosage and Administration 2. Zemuron was administered to geriatric patients 65 years or greater in US clinical trials and geriatric patients in European clinical trials. Clinical experiences and recommendations for use in geriatric patients are discussed in other sections [see Dosage and Administration 2.

Since Zemuron is primarily excreted by the liver, it should be used with caution in patients with clinically significant hepatic impairment. Zemuron 0. After Zemuron 0. The median recovery time of 53 minutes was also prolonged in patients with cirrhosis compared to 20 minutes in patients with normal hepatic function.

Four of 8 patients with cirrhosis, who received Zemuron 0. These findings are consistent with the increase in volume of distribution at steady state observed in patients with significant hepatic impairment [see Clinical Pharmacology If used for rapid sequence induction in patients with ascites, an increased initial dosage may be necessary to assure complete block.

Duration will be prolonged in these cases. The use of doses higher than 0. Due to the limited role of the kidney in the excretion of Zemuron, usual dosing guidelines should be followed. In patients with renal dysfunction, the duration of neuromuscular blockade was not prolonged; however, there was substantial individual variability range: minutes [see Clinical Pharmacology Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia.

The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent.

Reversal of Neuromuscular Blockade: Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended. Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e. Ventilation must be supported while patients exhibit any signs of muscle weakness.

Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances the management is the same as that of prolonged neuromuscular blockade.

Zemuron rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. Zemuron is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration.

It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. Table 4 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.

The clinical durations for the first 5 maintenance doses, in patients receiving 5 or more maintenance doses are represented in Figure 3 [see Dosage and Administration 2. Only 5 of adults reversed received an additional dose of reversal agent. The median range dose of neostigmine was 0.

The neuromuscular blocking action of Zemuron may be enhanced in the presence of potent inhalation anesthetics [see Drug Interactions 7. Most of the pediatric patients developing tachycardia were from a single study where the patients were anesthetized with halothane and who did not receive atropine for induction [see Clinical Studies Animal studies have indicated that the ratio of vagal:neuromuscular block following Zemuron administration is less than vecuronium but greater than pancuronium.

The tachycardia observed in some patients may result from this vagal blocking activity. Histamine Release: In studies of histamine release, clinically significant concentrations of plasma histamine occurred in 1 of 88 patients. Clinical signs of histamine release flushing, rash, or bronchospasm associated with the administration of Zemuron were assessed in clinical trials and reported in 9 of 0.

Adult and Geriatric Patients: In an effort to maximize the information gathered in the in vivo pharmacokinetic studies, the data from the studies was used to develop population estimates of the parameters for the subpopulations represented e. These population-based estimates and a measure of the estimate variability are contained in the following section. Following intravenous administration of Zemuron, plasma levels of rocuronium follow a three-compartment open model.

The rapid distribution half-life is 1 to 2 minutes and the slower distribution half-life is 14 to 18 minutes. In general, studies with normal adult subjects did not reveal any differences in the pharmacokinetics of rocuronium due to gender. Studies of distribution, metabolism, and excretion in cats and dogs indicate that rocuronium is eliminated primarily by the liver.

The rocuronium analog desacetyl-rocuronium, a metabolite, has been rarely observed in the plasma or urine of humans administered single doses of 0. In the cat, desacetyl-rocuronium has approximately one-twentieth the neuromuscular blocking potency of rocuronium. The effects of renal failure and hepatic disease on the pharmacokinetics and pharmacodynamics of rocuronium in humans are consistent with these findings.

In general, patients undergoing cadaver kidney transplant have a small reduction in clearance which is offset pharmacokinetically by a corresponding increase in volume, such that the net effect is an unchanged plasma half-life. Patients with demonstrated liver cirrhosis have a marked increase in their volume of distribution resulting in a plasma half-life approximately twice that of patients with normal hepatic function. Table 8 shows the pharmacokinetic parameters in subjects with either impaired renal or hepatic function.

The net result of these findings is that subjects with renal failure have clinical durations that are similar to but somewhat more variable than the duration that one would expect in subjects with normal renal function. Hepatically impaired patients, due to the large increase in volume, may demonstrate clinical durations approaching 1.

In both populations the clinician should individualize the dose to the needs of the patient [see Dosage and Administration 2. The use of a loading dose and a smaller infusion rate reduces the need for adjustment of dose. Pediatric Patients: Under halothane anesthesia, the clinical duration of effects of Zemuron did not vary with age in patients 4 months to 8 years of age. The terminal half-life and other pharmacokinetic parameters of rocuronium in these pediatric patients are presented in Table 9.

All pharmacokinetic parameters were found to be linearly proportional to body weight. In patients under the age of 18 years clearance CL and volume of distribution Vss increase with bodyweight kg and age years. As a result the terminal half-life of Zemuron decreases with increasing age from 1.

Studies in animals have not been performed with rocuronium bromide to evaluate carcinogenic potential or impairment of fertility. Mutagenicity studies Ames test, analysis of chromosomal aberrations in mammalian cells, and micronucleus test conducted with rocuronium bromide did not suggest mutagenic potential.

In US clinical studies, a total of patients received Zemuron, including pediatric, geriatric, 55 obstetric, and other adults. In European clinical studies, a total of patients received Zemuron, including 52 pediatric, geriatric 65 years or greater , and other adults. Intubation using doses of Zemuron 0. Excellent to good intubating conditions were generally achieved within 2 minutes and maximum block occurred within 3 minutes in most patients.

Larger doses 0. Cardiovascular Disease: In 1 clinical study, 10 patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft received an initial dose of 0. Neuromuscular block was maintained during surgery with bolus maintenance doses of 0. Most of the patients also received a premedication such as midazolam or temazepam.

Most patients had intubation attempted within 60 to 90 seconds of administration of Zemuron 0. The duration of action of Zemuron 0. In 1 clinical study in obese patients, Zemuron 0. Obese patients dosed according to IBW had a longer time to maximum block, a shorter median range clinical duration of 25 minutes, and did not achieve intubating conditions comparable to those dosed based on ABW. These results support the recommendation that obese patients be dosed based on actual body weight [see Dosage and Administration 2.

Obstetric Patients: Zemuron 0. Therefore, Zemuron is not recommended for rapid sequence induction in Cesarean section patients. Zemuron was evaluated in 55 geriatric patients ages years in 6 clinical studies. Doses of 0. In 1 of these studies maintenance bolus and infusion requirements were evaluated in patients. In all age groups, doses of 0.

Across all age groups, median range time to reappearance of T 3 for doses of 0. For pediatric patients older than 3 months, the time to recovery was shorter after stopping infusion maintenance when compared with bolus maintenance [see Dosage and Administration 2.

This dose provided a median range time of clinical relaxation of 41 minutes in 3-month to 1-year-old infants and 26 minutes in 1- to year-old pediatric patients [see Dosage and Administration 2. Use opened vials of Zemuron within 30 days. Safety and Handling: There is no specific work exposure limit for Zemuron. In case of eye contact, flush with water for at least 10 minutes.

Obtain information about your patient's medical history, current medications, any history of hypersensitivity to rocuronium bromide or other neuromuscular blocking agents. If applicable, inform your patients that certain medical conditions and medications might influence how Zemuron works. In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including Zemuron, have been reported. Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents.

Manufactured by: Organon Ireland Ltd. All rights reserved. Zemuron Generic name: rocuronium bromide Dosage form: injection, solution Drug class: Neuromuscular blocking agents Medically reviewed by Drugs. Patients receiving doses of 0. Adults 18 to 64 yrs 0.

Figure 3: Duration of Clinical Effect vs. Number of Zemuron Maintenance Doses, by Dose. Box of 10 NDC Inactive Ingredients Ingredient Name Strength sodium acetate 2 mg in 1 mL sodium chloride sodium hydroxide acetic acid. When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1.

No differences from patients with normal plasma cholinesterase activity are expected since rocuronium metabolism does not depend on plasma cholinesterase. The median clinical duration of a dose of 0. Resistance to nondepolarizing agents, consistent with up-regulation of skeletal muscle acetylcholine receptors, is associated with burns, disuse atrophy, denervation, and direct muscle trauma. Other nondepolarizing neuromuscular blocking agents have been found to exhibit profound neuromuscular blocking effects in cachectic or debilitated patients, patients with neuromuscular diseases, and patients with carcinomatosis.

In these or other patients in whom potentiation of neuromuscular block or difficulty with reversal may be anticipated, a decrease from the recommended initial dose should be considered. Certain antibiotics, magnesium salts, lithium, local anesthetics, procainamide, and quinidine have been shown to increase the duration of neuromuscular block and decrease infusion requirements of other neuromuscular blocking agents.

No data are available in such patients and no dosing recommendations can be made. In patients with myasthenia gravis or myasthenic Eaton-Lambert syndrome, small doses of nondepolarizing neuromuscular blocking agents 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. These reactions have, in some cases, been life threatening. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken.

Special precautions should be taken in patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since allergic cross-reactivity has been reported in this class of drugs. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor. The median recovery time of 53 minutes was also prolonged in patients with cirrhosis compared to 20 minutes in patients with normal hepatic function.

If used for rapid sequence induction in patients with ascites, an increased initial dosage may be necessary to assure complete block. Duration will be prolonged in these cases. The use of doses higher than 0. The mean SD clinical duration of 54 22 minutes was not considered prolonged compared to 46 12 minutes in normal patients; however, there was substantial variation range, minutes. Clinicians should be prepared for the possibility of these reactions and take the necessary precautions, including the immediate availability of emergency treatment see WARNINGS.

Conditions associated with slower circulation time, e. Interactions have been observed when other nondepolarizing muscle relaxants have been administered in succession. Experience concerning injection of quinidine during recovery from use of other muscle relaxants suggests that recurrent paralysis may occur.

Both respiratory and metabolic acidosis prolonged the recovery time. In addition, experience with other drugs has suggested that acute e. Since electrolyte imbalance and acid-base imbalance are usually mixed, either enhancement or inhibition may occur. Magnesium salts, administered for the management of toxemia of pregnancy, may enhance neuromuscular blockade. Studies in animals have not been performed to evaluate carcinogenic potential or impairment of fertility.

Developmental toxicology studies have been performed in pregnant, conscious, nonventilated rabbits and rats. Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high-dose and was administered intravenously three times a day to rats 0. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.

Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high-dose in rats most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.

However, there are no adequate and well-controlled studies in pregnant women. Prolonged neuromuscular block is associated with neuromuscular blockers as a class. Prolonged neuromuscular block minutes occurred after 0. The patients exposed in the US clinical studies provide the basis for calculation of adverse reaction rates.

Changes in heart rate and blood pressure were defined differently from the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related. Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia.

The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent e. Patients should be evaluated for adequate clinical evidence of antagonism, e. Ventilation must be supported until no longer required. Antagonism may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular blockade or separately cause respiratory depression.

Under such circumstances the management is the same as that of prolonged neuromuscular blockade. The dosage information which follows is derived from studies based upon units of drug per unit of body weight. The recommended initial dose regardless of anesthetic technique is 0. Maximum blockade is achieved in most patients in less than 3 minutes.

Maximum blockade is achieved in most patients in less than 4 minutes. Patients receiving this low dose of 0.

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Anesthesiology and Critical Care Drug Handbook. Hudson, OH: Lexi-Comp; Muscle Relaxants - Adjuncts to Anesthesia. In: Wickersham, R. Drug Facts and Comparisons eFacts. Neuromuscular Blocking Agents. American Society of Health-System Pharmacists. Drug Shortage Resource Center. Accessed on December 14, Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment.

Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Any application of this information for any purpose shall be limited to personal, non-commercial use. Subscribe to AHFS Clinical Drug Information to get direct access to integrated drug shortages content, plus comprehensive and actionable drug information.

View Related Links. Estimated Resupply Dates All marketed presentations are currently available. Implications for Patient Care Rocuronium is a rapid- to intermediate-acting neuromuscular blocking agent NMBA used to facilitate intubation and relax skeletal muscles as an adjunct to general anesthesia during surgery or mechanical ventilation. Safety Clinicians must use extreme caution to prevent dosing errors if 10 mL vials are used in place of 5 mL vials.

Midyear continuing education policy positions and guidelines residency for presenters get involved in a meeting drug shortages. Methods: Twenty-nine healthy male volunteers were enrolled to investigate the safety, pharmacokinetics, and efficacy of Org In part 1, Org or placebo was administered to 19 subjects during one to three treatment periods each.

In part 2, a further 10 subjects received general anesthesia on two separate occasions, using an intubating dose of 0. Three minutes after rocuronium administration, Org or placebo was given in random order. Six doses of 0. No adverse events required any treatment, and all subjects recovered from them.