Vecuronium

Serious side effects have been reported with vecuronium. See the “Drug Precautions" section.

Common side effects of vecuronium include a slower heart beat, low blood pressure, and flushing.

This is not a complete list of vecuronium side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You should not receive vecuronium if you are allergic to it. Tell your doctor if you have ever had a severe allergic reaction to any type of anesthesia.

To make sure vecuronium is safe for you, tell your doctor if you have:

• myasthenia gravis;

• cirrhosis or other liver disease;

• a history of kidney disease;

• heart disease or congestive heart failure;

• problems with circulation; or

• a nerve-muscle disorder such as ALS (Lou Gehrig's disease), MS (multiple sclerosis), or muscular dystrophy.

FDA pregnancy category C. It is not known whether vecuronium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether vecuronium passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

• If you have an allergy to vecuronium or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take vecuronium with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Anaphylaxis: Severe anaphylactic reactions to neuromuscular blocking agents, including Vecuronium bromide, 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 also 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.

Vecuronium SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE 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. TO REDUCE THE POSSIBILITY OF PROLONGED NEUROMUSCULAR BLOCKADE AND OTHER POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING LONG-TERM USE IN THE I.C.U., Vecuronium OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSES BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND WHO ARE FAMILIAR WITH APPROPRIATE PERIPHERAL NERVE STIMULATOR MUSCLE MONITORING TECHNIQUES (see PRECAUTIONS, Long Term Use in I.C.U.).

In patients who are known to have myasthenia gravis or the myasthenic (Eaton-Lambert) syndrome, small doses of Vecuronium 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.

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 Vecuronium bromide have been reported.

Renal Failure: Vecuronium is well tolerated without clinically significant prolongation of neuromuscular blocking effect in patients with renal failure who have been optimally prepared for surgery by dialysis. Under emergency conditions in anephric patients some prolongation of neuromuscular blockade may occur; therefore, if anephric patients cannot be prepared for non-elective surgery, a lower initial dose of Vecuronium should be considered.

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 delay in onset time, therefore, dosage should not be increased.

Hepatic Disease: Experience in patients with cirrhosis or cholestasis has revealed prolonged recovery time in keeping with the role the liver plays in Vecuronium metabolism and excretion (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Data currently available do not permit dosage recommendations in patients with impaired liver function.

Long-term Use in I.C.U.: In the intensive care unit, 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. The recovery picture may vary from regaining movement and strength in all muscles to initial recovery of movement of the facial and small muscles of the extremities then to the remaining muscles. In rare cases recovery may be over an extended period of time and may even, on occasion, involve rehabilitation. Therefore, when there is a need for long-term mechanical ventilation, the benefit-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. IN THE INTENSIVE CARE UNIT, APPROPRIATE MONITORING, WITH THE USE OF A PERIPHERAL NERVE STIMULATOR TO ASSESS THE DEGREE OF NEUROMUSCULAR BLOCKADE IS RECOMMENDED TO HELP PRECLUDE POSSIBLE PROLONGATION OF THE BLOCKADE. WHENEVER THE USE OF Vecuronium OR ANY NEUROMUSCULAR BLOCKING AGENT IS CONTEMPLATED IN THE I.C.U., IT IS RECOMMENDED THAT NEUROMUSCULAR TRANSMISSION BE MONITORED CONTINUOUSLY DURING ADMINISTRATION AND RECOVERY WITH THE HELP OF A NERVE STIMULATOR. ADDITIONAL DOSES OF Vecuronium OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD NOT BE GIVEN BEFORE THERE IS A DEFINITE RESPONSE TO T1 OR TO THE FIRST TWITCH. IF NO RESPONSE IS ELICITED, INFUSION ADMINISTRATION SHOULD BE DISCONTINUED UNTIL A RESPONSE RETURNS.

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 Vecuronium.

Malignant Hyperthermia: Many drugs used in anesthetic practice are suspected of being capable of triggering a potentially fatal hypermetabolism of skeletal muscle known as malignant hyperthermia. There are insufficient data derived from screening in susceptible animals (swine) to establish whether or not Vecuronium is capable of triggering malignant hyperthermia.

C.N.S.: Vecuronium has no known effect on consciousness, the pain threshold or cerebration. Administration must be accompanied by adequate anesthesia or sedation.

Drug Interactions

Prior administration of succinylcholine may enhance the neuromuscular blocking effect of Vecuronium and its duration of action. If succinylcholine is used before Vecuronium, the administration of Vecuronium should be delayed until the succinylcholine effect shows signs of wearing off. With succinylcholine as the intubating agent, initial doses of 0.04 to 0.06 mg/kg of Vecuronium may be administered to produce complete neuromuscular block with clinical duration of action of 25 to 30 minutes (see CLINICAL PHARMACOLOGY).

The use of Vecuronium before succinylcholine, in order to attenuate some of the side effects of succinylcholine, has not been sufficiently studied.

Other nondepolarizing neuromuscular blocking agents (pancuronium, d-tubocurarine, metocurine, and gallamine) act in the same fashion as does Vecuronium, therefore, these drugs and Vecuronium, may manifest an additive effect when used together. There are insufficient data to support concomitant use of Vecuronium and other competitive muscle relaxants in the same patient.

Inhalational Anesthetics: Use of volatile inhalational anesthetics such as enflurane, isoflurane, and halothane with Vecuronium will enhance neuromuscular blockade. Potentiation is most prominent with use of enflurane and isoflurane. With the above agents the initial dose of Vecuronium may be the same as the balanced anesthesia unless the inhalational anesthetic has been administered for a sufficient time at a sufficient dose to have reached clinical equilibrium (see CLINICAL PHARMACOLOGY).

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 (such as neomycin, streptomycin, kanamycin, gentamicin, and dihydrostreptomycin); tetracyclines; bacitracin; polymyxin B; colistin; and sodium colistimethate. If these or other newly introduced antibiotics are used in conjunction with Vecuronium, unexpected prolongation of neuromuscular block should be considered a possibility.

Thiopental: Reconstituted Vecuronium, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions such as thiopental) in the same syringe or administered simultaneously during intravenous infusion through the same needle or through the same intravenous line (see DOSAGE AND ADMINISTRATION, COMPATIBILITY).

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 Vecuronium. Vecuronium induced neuromuscular blockade has been counteracted by alkalosis and enhanced by acidosis in experimental animals (cat). 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

Teratogenic Effects

Pregnancy Category C: Animal reproduction studies have not been conducted with Vecuronium. It is also not known whether Vecuronium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vecuronium should be given to a pregnant woman only if clearly needed.

Labor and Delivery

The use of Vecuronium in patients undergoing cesarean section has been reported in the literature. Following tracheal intubation with succinylcholine, Vecuronium dosages of 0.04 mg/kg (n=11) and 0.06 to 0.08 mg/kg (n=20) were administered. The umbilical venous plasma concentrations were 11% of maternal concentrations at delivery and mean neonate APGAR scores at 5 minutes were ≥ 9 in both reports. The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of toxemia of pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Vecuronium is administered to a nursing woman.

Pediatric Use

Infants under 1 year of age but older than 7 weeks also tested under halothane anesthesia, are moderately more sensitive to Vecuronium on a mg/kg basis than adults and take about 1½ times as long to recover. See DOSAGE AND ADMINISTRATION, Use in Pediatrics subsection for recommendations for use in pediatric patients 7 weeks to 16 years of age. The safety and effectiveness of Vecuronium in pediatric patients less than 7 weeks of age have not been established.

Geriatric Use

Clinical studies of Vecuronium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. There are some reports in the peer reviewed literature of increased effect and longer duration of action of Vecuronium in the elderly compared to younger patients. However, other reports have found no significant differences between healthy elderly and younger adults. Advanced age or other conditions associated with slower circulation time, may be associated with a delay in onset time (see PRECAUTIONS-Altered Circulation Time). Nevertheless, recommended doses of Vecuronium should not be increased in these patients to reduce onset time, as higher doses produce a longer duration of action (see CLINICAL PHARMACOLOGY). Dose selections for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Close monitoring of neuromuscular function is recommended.

Blocks acetylcholine from binding to receptors on motor endplate inhibiting depolarization

Distribution

Vd: 0.3-0.4 L/kg

Metabolism

Active metabolite: 3-desacetyl vecuronium (1/2 the activity of parent drug)

Excretion

Primarily feces (40% to 75%); urine (30% as unchanged drug and metabolites); the rate of elimination is appreciably reduced with hepatic dysfunction but not with renal dysfunction

Reconstitute with compatible solution (eg, D5W, NS) for injection to final concentration of 1 mg/mL. May further dilute reconstituted vial to 0.1 to 0.2 mg/mL in a compatible solution for IV infusion.

This drug should be administered by adequately trained individuals familiar with its actions, characteristics, and hazards.

Animal reproduction studies have not been conducted. The pharmacokinetics of vecuronium are altered during pregnancy. Use in cesarean section has been reported; umbilical venous concentrations were 11% of maternal values at delivery.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.