Generic Name: Pancuronium Bromide
Class: Neuromuscular Blocking Agents
VA Class: MS300
CAS Number: 15500-66-0
Should be administered only by individuals experienced in the use of neuromuscular blocking agents.a
Introduction
Nondepolarizing neuromuscular blocking agent.a
Uses for Pavulon
Skeletal Muscle Relaxation
Production of skeletal muscle relaxation during surgery after general anesthesia has been induced.a
Facilitation of endotracheal intubation.a
Treatment to increase pulmonary compliance during assisted or controlled respiration.a
Pavulon Dosage and Administration
General
Adjust dosage carefully according to individual requirements and response.a
Assess neuromuscular blockade and recovery in patients undergoing anesthesia; a peripheral nerve stimulator is recommended to accurately monitor the degree of muscle relaxation and to minimize the possibility of overdosage.a
To avoid patient distress, administer only after unconsciousness has been induced.a b c
Facilitation of Endotracheal Intubation
Endotracheal intubation generally can be performed within 2–3 minutes following administration of 0.06-mg/kg dose.a (See Onset and also Duration under Pharmacokinetics.)
Maintenance of Neuromuscular Blockade
Supplemental doses to maintain muscle relaxation increase magnitude and duration of neuromuscular blockade.a
Reversal of Neuromuscular Blockade
To reverse neuromuscular blockade, administer a cholinesterase inhibitor (e.g., neostigmine, pyridostigmine, edrophonium), usually in conjunction with an antimuscarinic (e.g., atropine, glycopyrrolate) to block adverse muscarinic effects of the cholinesterase inhibitor.a c
Administration
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer IV only; administer initial (intubating) dose by rapid IV injection.a
Consult specialized references for specific procedures and techniques of administration.b
Dosage
Available as pancuronium bromide; dosage expressed in terms of the salt.a
Pediatric Patients
Skeletal Muscle Relaxation
Initial Dosage
IV
Children >1 month of age: 0.04–0.1 mg/kg as adjunct to balanced anesthesia.a 0.06–0.1 mg/kg is recommended for endotracheal intubation.a (See Onset and also Duration under Pharmacokinetics.)
If administering following succinylcholine and/or maintenances doses of inhalation anesthetics (e.g., enflurane, halothane, isoflurane), use dosage at lower end of recommended initial range.a Administer after effects of succinylcholine subside.a
Neonates ≤1 month of age: Administer test dose of 0.02 mg/kg to determine responsiveness.a
Maintenance Dosage
IV
Children 3 months to 12 years of age: 0.01 mg/kg administered at 25- to 60-minute intervals to maintain skeletal muscle relaxation during prolonged surgery or assisted respiration;a b 0.015 mg/kg may be used to maintain relaxation for controlled respiration.b
Adults
Skeletal Muscle Relaxation
Initial Dosage
IV
0.04–0.1 mg/kg as adjunct to balanced anesthesia.a 0.06–0.1 mg/kg is recommended for endotracheal intubation.a (See Onset and also Duration under Pharmacokinetics.)
If administering following succinylcholine and/or maintenances doses of inhalation anesthetics (e.g., enflurane, halothane, isoflurane), use dosage at lower end of recommended initial range.a Administer after effects of succinylcholine subside.a
Maintenance Dosage
IV
0.01 mg/kg administered at 25- to 60-minute intervals to maintain skeletal muscle relaxation during prolonged surgery or assisted respiration.a b 0.015 mg/kg may be used to maintain relaxation for controlled respiration.b
Prescribing Limits
Pediatric Patients
Skeletal Muscle Relaxation
Initial Dosage
IV
Up to 0.16 mg/kg has been used; however, large doses may increase frequency and severity of tachycardia.b
Adults
Skeletal Muscle Relaxation
Initial Dosage
IV
Up to 0.16 mg/kg has been used; however, large doses may increase frequency and severity of tachycardia.b
Special Populations
Hepatic Impairment
Increased initial dosage may be required to achieve effective neuromuscular blockade; once blockade is established, duration of blockade may be prolonged.a (See Hepatic Impairment under Cautions.)
Renal Impairment
Careful and individualized dosing recommended.a (See Renal Impairment under Cautions.)
Patients with Biliary Disease
Increased initial dosage may be required to achieve effective neuromuscular blockade; once blockade is established, duration of blockade may be prolonged.a (See Biliary Disease under Cautions.)
Burn Patients
Substantially increased doses may be required due to development of resistance.c (See Burn Patients under Cautions.)
Patients with Neuromuscular Disease
Administer small test dose and monitor response.a (See Neuromuscular Disease under Cautions.)
Cautions for Pavulon
Contraindications
Known hypersensitivity to pancuronium bromide or any ingredient in the formulation.a
Warnings/Precautions
Warnings
Respiratory Effects
Potential for severely compromised respiratory function and respiratory paralysis.c
Should be used only by individuals experienced in the use of neuromuscular blocking agents and in the maintenance of an adequate airway and respiratory support.a Facilities and personnel necessary for intubation, administration of oxygen, and assisted or controlled respiration should be immediately available.a
IV cholinesterase inhibitor (e.g., neostigmine, pyridostigmine, edrophonium) should be readily available.a (See Reversal of Neuromuscular Blockade under Dosage and Administration.)
Use with caution in patients with pulmonary impairment or respiratory depression.c
Neuromuscular Disease
Possible profound neuromuscular blockade in patients with neuromuscular disease (e.g., myasthenia gravis, Eaton-Lambert syndrome).a
Reduce initial dosage; monitor response carefully with a peripheral nerve stimulator.a
Sensitivity Reactions
Hypersensitivity Reactions
Hypersensitivity reactions (bronchospasm, flushing, redness, hypotension, tachycardia) reported rarely.a
General Precautions
Burn Patients
Resistance to therapy with neuromuscular blocking agents can develop in burn patients,c particularly those with burns over 25–30% or more of body surface area.c
Resistance generally becomes apparent ≥1 week after the burn, peaks ≥2 weeks after the burn, persists for several months or longer, and decreases gradually with healing.c
Consider possible need for substantially increased doses.c
Cardiovascular Effects
Possible increased heart rate, arterial pressure, and cardiac output.a
Use not recommended in patients with preexisting tachycardia or in patients in whom minor elevation in heart rate is undesirable.b
Intensive Care Setting
Possible prolonged paralysis and/or muscle weakness and atrophy.a
Continuous monitoring of neuromuscular transmission recommended during neuromuscular blocking agent therapy in intensive care setting.c Do not administer additional doses before there is a definite response to nerve stimulation tests.c If no response is elicited, discontinue administration until a response returns.c
Impaired Circulation
Possible delayed onset of action in patients with impaired circulation (e.g., cardiovascular disease, edema);a however, larger than usual doses are not recommended.a
Electrolyte Disturbances
Possible increased or decreased neuromuscular blockade in patients with electrolyte distrubances (e.g., adrenocortical insufficiency) or acid/base imbalances.a
Malignant Hyperthermia
Malignant hyperthermia is rarely associated with use of neuromuscular blocking agents and/or potent inhalation anesthetics.c Be vigilant for its possible development and prepared for its management in any patient undergoing general anesthesia.c
Obesity
Possible airway or ventilatory problems in patients with severe obesity.a Use with caution.a
Biliary Disease
Possible slower onset and prolonged duration of neuromuscular blockade.a (See Elimination: Special Populations, under Pharmacokinetics and also see Patients with Biliary Disease under Dosage and Administration.)
Specific Populations
Pregnancy
Category C.a
Lactation
Not known whether pancuronium is distributed into milk.j
Pediatric Use
Excessive salivation may occur during very light anesthesia.b
Clinically important methemoglobinemia reported rarely in premature neonates receiving pancuronium in combination with fentanyl and atropine for emergency anesthesia and surgery; however, direct causal relationship not established.a
Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity in neonates;a d e f g h i each mL of pancucronium bromide injection contains 10 mg of benzyl alcohol.a
Neonates (<1 month of age) are particularly sensitive to neuromuscular blocking agents;a administer test dose to determine responsiveness.a (See Pediatric Patients under Dosage and Administration.) Carefully consider risks and benefits of long-term therapy in neonates.a (See Intensive Care Setting under Cautions.)
Geriatric Use
Use with caution in geriatric or debilitated patients.a c
Hepatic Impairment
Possible slower onset and prolonged duration of neuromuscular blockade; use with caution.a (See Elimination: Special Populations, under Pharmacokinetics and also see Hepatic Impairment under Dosage and Administration.)
Renal Impairment
Possible prolonged neuromuscular blockade; use with caution in patients with poor renal perfusion or severe renal disease.a b (See Elimination: Special Populations, under Pharmacokinetics.)
Common Adverse Effects
Skeletal muscle weakness, slight elevation in pulse rate and excessive salivation.a c
Interactions for Pavulon
Specific Drugs
Drug | Interaction | Comments |
---|---|---|
Anesthetics, general (enflurane, halothane, isoflurane) | Increased potency of neuromuscular blockadea | Select pancuronium dosage at lower end of recommended initial range a |
Antidepressants, tricyclic | Possible ventricular arrhythmias in patients receiving tricyclic antiderpessants concomitantly with pancuronium and halothanea | Use with cautiona |
Anti-infective agents (aminoglycosides, bacitracin, polymyxins, tetracyclines) | Possible prolonged duration of neuromuscular blockadea | |
Magnesium salts | Possible increased neuromuscular blockadea | Reduce pancuronium dosage if necessary a |
Neuromuscular blocking agents, nondepolarizing (e.g., atracurium, vecuronium) | Increased potency of neuromuscular blockadea | Concomitant use not recommendeda |
Quinidine | Possible recurrence of paralysisa | |
Succinylcholine | Prior administration of succinylcholine may increase potency and prolong duration of neuromuscular blockadea | Allow effects of succinylcholine to subside before administering pancuroniuma |
Pavulon Pharmacokinetics
Absorption
Bioavailability
Poorly absorbed from the GI tract.c
Onset
Onset of paralysis is dose related.b
Following IV administration of 0.06 mg/kg, clinically sufficient neuromuscular blockade occurs within 2–3 minutes.b
Duration
Duration of paralysis is dose related.b
Duration of clinically sufficient neuromuscular blockade induced by 0.06 mg/kg is about 35–45 minutes.b
Supplemental doses may increase magnitude and duration of neuromuscular blockade.b
Distribution
Extent
Crosses the placenta in small amounts.b
Plasma Protein Binding
Approximately 87% (mainly γ-globulin; albumin to a lesser extent).100 101 102 104 May be concentration dependent.101 103 104
Special Populations
Hepatic103 or renal105 impairment does not affect protein binding. Impaired hepatic or biliary function may increase volume of distribution.a
Elimination
Metabolism
Undergoes limited biotransformation.b
Elimination Route
Excreted principally in urine as unchanged drug and to a lesser extent in bile.a
Half-life
Triphasic; terminal half-life is approximately 2 hours.b
Special Populations
Impaired renal or hepatic function or biliary disease may decrease clearance and prolong half-life.a
Stability
Storage
Parenteral
Injection
2–8°C.a
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution Compatibilitya
Compatible |
---|
Dextrose 5% in sodium chloride 0.45 or 0.9% |
Dextrose 5% in water |
Ringer's injection, lactated |
Sodium chloride 0.9% |
Drug Compatibility
Compatible |
---|
Ciprofloxacin |
Verapamil HCl |
Compatible |
---|
Aminophylline |
Cefazolin sodium |
Cefuroxime sodium |
Cimetidine HCl |
Co-trimoxazole |
Dobutamine HCl |
Dopamine HCl |
Epinephrine HCl |
Esmolol HCl |
Etomidate |
Fenoldopam mesylate |
Fentanyl citrate |
Fluconazole |
Gentamicin sulfate |
Heparin sodium |
Hetastarch in lactated electrolyte injection (Hextend) |
Hydrocortisone sodium succinate |
Isoproterenol HCl |
Levofloxacin |
Lorazepam |
Midazolam HCl |
Milrinone lactate |
Morphine sulfate |
Nitroglycerin |
Ranitidine HCl |
Sodium nitroprusside |
Vancomycin HCl |
Incompatible |
Diazepam |
Thiopental sodium |
Variable |
Propofol |
ActionsActions
Produces skeletal muscle relaxation by causing a decreased response to acetylcholine (ACh) at the myoneural (neuromuscular) junction of skeletal muscle.c
Exhibits high affinity for ACh receptor sites and competitively blocks access of ACh to motor end-plate of myoneural junction; may affect ACh release.a c
Blocks the effects of both the small quantities of ACh that maintain muscle tone and the large quantities of ACh that produce voluntary skeletal muscle contraction; does not alter the resting electrical potential of the motor end-plate or cause muscular contractions.c
Produces little or no histamine release.b c
Advice to Patients
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, neuromuscular disease).a
Importance of informing patients of other important precautionary information.a (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Oral | Injection, for IV use only | 1 mg/mL* | Pancuronium Bromide Injection (with benzyl alcohol 1%) | Abbott, Baxter, Sicor |
2 mg/mL* | Pancuronium Bromide Injection (with benzyl alcohol 1%) | Abbott, Baxter, Sicor |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Pavulon prescribing information. In: Huff BB, ed. Physicians’ desk reference. 42nd ed. Oradell, NJ: Medical Economics Company Inc; 1988:1491-3.
101. Thompson JM. Pancuronium binding by serum proteins. Anaesthesia. 1976; 31:219-27. [PubMed 59554]
102. Foldes FF, Derby A. Protein binding of atracurium and other short-acting neuromuscular blocking agents and their interaction with human cholinesterases. Br J Anaesth. 1983; 55:31-4S.
103. Duvaldestin P, Henzel D. Binding of tubocurarine, fazadinium, pancuronium and Org NC45 to serum proteins in normal man and in patients with cirrhosis. Br J Anaesth. 1982; 54:513-6. [PubMed 6122460]
104. Ramzan MI, Somogyi AA, Walker JS et al. Clinical pharmacokinetics of the non-depolarising muscle relaxants. Clin Pharmacokinet. 1981; 6:25-60. [IDIS 165379] [PubMed 7018787]
105. Wood M, Stone WJ, Wood AJJ. Plasma binding of pancuronium: effects of age, sex, and disease. Anesth Analg. 1983; 62:29-32. [IDIS 164399] [PubMed 6849508]
a. Baxter. Pancuronium bromide injection prescribing information. Deerfield, IL: 2003 Jun.
b. AHFS Drug Information 2004. McEvoy GK, ed. Pancuronium bromide. Bethesda, MD: American Society of Health-System Pharmacists; 2004:1313-4.
c. AHFS Drug Information 2004. McEvoy GK, ed. Neuromuscular blocking agents general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:1303-6.
d. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12:10-11. [PubMed 7188569]
e. Anon. Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982; 31:290-91. [IDIS 150868] [PubMed 6810084]
f. Gershanik J. Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]
g. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]
h. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]
i. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]
j. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2002:1058-62.
HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1281-3.
More Pavulon resources
- Pavulon Drug Interactions
- Pavulon Support Group
- 0 Reviews · Be the first to review/rate this drug
- Pancuronium Prescribing Information (FDA)
No comments:
Post a Comment