Nursing Pharmacology Help:
Paper on Amiodarone in the Neonate

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Amiodarone use in Infants and Neonates


Supraventricular tachycardia (SVT) is one of the most common tachyarrhythmias in young children. The initial presentation of children with SVT is under 1 year of age with the majority being less than 1 month of age. Amiodarone is a class III antiarrhythmic drug. It “is one of the most effective agents available for treatment of refractory arrhythmias in children, but one of the most feared because of its possible side effects.” (Moak, 2000, p. 35) For a drug that is feared, amiodarone is used quite frequently in the neonatal and infant population for multiple arrhythmias. With the risks that are reported it is surprising to see it used so frequently. Do the risks outweigh the benefits? Is amiodarone safe for these young children? The safety and efficacy of amiodarone in infants and neonates appears controversial with conflicting information being offered by Aschenbrenner & Venable and the fact that the drug is used in this population at a large pediatric facility.

Rationale for Topic

Amiodarone is a drug treatment that is frequently used at one of the largest pediatric hospitals in the country. While studying the cardiovascular unit for pharmacotherapeutics, the information on amiodarone raised many questions regarding its safety in infants and neonates. This information included the risks to young children, especially infants, and also that stated that it is not approved for use in children. Aschenbrenner and Venable (2009) specifically state to evaluate age prior to giving amiodarone as “safety and efficacy have not been established in children.” (p 583) They also state that benzyl alcohol is a preservative in some products and that this preservative has been “associated with a fatal “gasping syndrome” in premature infants.” (p. 583) They also discuss some severe adverse effects, with the most important being pulmonary toxicity. Other adverse effects listed included exacerbation of the arrhythmia, liver disease, optic neuritis, optic neuropathy and hypotension. The perception received while reading Aschenbrenner and Venable (2009) is that amiodarone is unsafe for pediatric use. Being a witness that it is used in this same patient population despite the risks leaves questions. Included in these questions are topics such as what is the drug for, has it been proven effective, and do the benefits outweigh these potential risks.

Amiodarone

Amiodarone is a Class III antiarrhythmic that works to prolong the repolarization and refractory phases of the cardiac cycle. Amiodarone has the potential for some severe or lethal adverse effects. Due to this fact it has only been approved for use in life-threatening arrhythmias or when alternative therapies are not tolerated or are ineffective. (Aschenbrenner & Venable, 2009, p. 580) It is currently approved for treatment of recurrent ventricular fibrillation and recurrent unstable ventricular tachycardia. It is also given been given for unlabelled uses such as for refractory sustained or paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia and symptomatic atrial flutter. (Karch, 2009, pp. 111-112) Intravenous amiodarone is fast acting and therefore effective for life-threatening arrhythmias whereas oral dosing is slower acting. (Figa, Gow, Hamilton, & Freedom, 1994) Amiodarone is approved for use in life-threatening arrhythmias despite the potential for some serious adverse effects.

The Risks

Amiodarone has some potentially serious adverse effects which include thyroid dysfunction, hepatic failure, hyperglycemia, pulmonary fibrosis, hypotension, sinus bradycardia, heart block, prolonged QT and increased QRS. It can also cause cellulitis or abscess to the IV site. (Yildirim, Tilker, Cengiz, & Kilicdag, 2005) (Figa et al., 1994) Potential drug interactions include digoxin, cyclosporine, warfarin, quinidine, procainamide, felcainide, and phenytoin. There is also a potential for sinus arrest and heart block when given with beta-blockers and calcium channel blockers. (Karch, 2009) One reported case study shows a potential tie between electrolyte imbalance and amiodarone. The studies suggest that amiodarone effects may be reversed by hyperkalemia, and therefore it is suggested that amiodarone be used with caution in a patient with hyperkalemia as the tachycardia may recur. (Yildirim, Tilker, Cengiz, & Kilicdag, 2005) IV amiodarone has a label warning that it can “cause plastic to leach out of I.V. tubing, including polyvinyl chloride tubing.” The amount of leaching increases with slower infusion rates and higher concentrations. This plastic exposure can potentially have an effect on the reproductive tract development of male infants and toddlers. IV bolus administration is recommended for this reason. (New labeling addresses off-label pediatric use, 2001) A study at Primary Children’s Medical Center determined that amiodarone is safe for use in neonates. They determined that adverse effects were minimal and no effects occurred that required withdrawal of treatment. They also determined that amiodarone is better tolerated by infants than it is by adults. Although it is considered safe an initial load is recommended in an inpatient setting. (Etheridge, Craig, & Compton, 2001) Hass and Camphausen (2008) also found no significant adverse effects. They do point out that in some studies significant hypotension was noted which was usually related to a rapid bolus infusion and was dose dependent. All studies reviewed have concluded that amiodarone is safe for us in infants and neonates.

The Benefits

Amiodarone has been noted to be one of the most effective drug treatments for refractory arrhythmias in children. SVT occurs most often in children under 1 month of age. These infants with severe SVT must be treated immediately with a drug such as amiodarone. (Yildirim, Tilker, Cengiz, & Kilicdag, 2005) The study at Primary Children’s Medical Center concluded that amiodarone was effective in about 50% of the patients as a single treatment; the other 50% of patients required a combination of propranolol and amiodarone to be effective. Those patients that required the combination therapy were also the same group that required a larger loading dose initially, leading to a conclusion that their arrhythmias were likely harder to treat. (Etheridge, Craig, & Compton, 2001) Haas and Camphausen (2008) discuss another study in relation to timing of amiodarone initiation. They summarize that amiodarone is considered safe and effective and that it is now listed as a treatment for malignant ventricular arrhythmias in the pediatric advanced life support algorithm. Their study also demonstrated that early treatment with amiodarone in infants was beneficial. (Haas & Camphausen, in press) A study at Children’s Hospital, Boston had the same results. They also determined amiodarone to be safe and effective in these infants. (Weindling, Saul, & Walsh, 1996) According to Rosenthal et al (2004) junctional ectopic tachycardia responds well to IV amiodarone. They also include it in the treatment of ventricular tachycardia (VT). Lidocaine is considered a first line drug for VT and amiodarone can be used if it is unsuccessful. Amiodarone is preferred over procainamide because it has a lower incidence of hypotension or arrhythmia aggravation. Paroxysmal supraventricular tachycardia can be treated with amiodarone for recurrent episodes, while adenosine is the drug of choice for the initial treatment. Amiodarone has a higher success rate and lower risk of adverse effects which causes it to stand out as an appropriate drug treatment. It is “usually well tolerated, even in patients with poor contractility.” (Rosenthal et al., 2004, p. 1325) The various studies have shown amiodarone to be safe and effective despite the potential adverse effects. These adverse effects do remain a potential risk and caregivers must be able to monitor the infants for them.



Nursing Implications

A nurse must be aware of what to look for in an infant or neonate. Symptomatic arrhythmias may show symptoms such as congestive heart failure, poor perfusion and unresponsiveness. Sometimes the arrhythmia may not cause the infant or neonate to be symptomatic and therefore may go unnoticed. In these situations it is important for a nurse to know what to look for. (Miller-Hoover, 2006) A neonate with SVT may present with more subtle signs than an older child. Symptoms may include pallor, cyanosis, irritability, restlessness, tachypnea, feeding difficulty, grunting and diaphoresis. (Moak, 2000) The nurse should be able to recognize the life-threatening arrhythmias on the cardiorespiratory monitor so that proper treatment can be initiated. “Recognition and treatment of cardiac arrhythmias are an essential piece of caring for the neonate or infant. All caregivers should be able to determine the differences among ST, SVT and VT.” (Miller-Hoover, 2006, p. 173) During amiodarone therapy it is important for the nurse to assess for new arrhythmias or worsening of the arrhythmia that is being treated. This nursing assessment should be ongoing throughout the patient’s treatment. A patient receiving amiodarone in an acute care setting should have their cardiac rhythm monitored continuously. Patients receiving IV amiodarone should be in an intensive care setting to allow for this continuous monitoring. Hypotension is most likely to occur during the start of treatment; therefore it is important for the nurse to monitor the patient’s blood pressure frequently during this time. IV amiodarone infusions should be given through a central venous catheter if possible to prevent phlebitis. The nurse should also be aware that aminophylline, cefazolin, heparin, mezlocillin, cefamandole and sodium bicarbonate should not be given along with amiodarone as they tend to form precipitates. These drugs are. Once the patient is stabilized on IV amiodarone the patient may be changed to oral amiodarone. The nurse should continue close monitoring of the patient when changing to oral dosing and with dose adjustments. The nurse should give oral amiodarone with food to avoid GI symptoms such as nausea and vomiting. (Aschenbrenner & Venable, 2009)

From a nursing standpoint, a nurse should be aware that a normal amiodarone dose for a life-threatening arrhythmia is a loading dose of 5mg/kg followed by a maintenance dose of 7.5 mg/kg/day to a maximum of 21.6 mg/kg/day. The IV administration should be given cautiously and the nurse should be aware of the potential for plastic leaching. (New labeling addresses off-label pediatric use, 2001) The amiodarone itself can also absorb into PVC IV tubing and the dosing recommendations are made taking the use of this tubing into consideration therefore the PVC tubing should be used for IV administration. (Aschenbrenner & Venable, 2009) The nurse should also be aware of Haas and Camphausen’s (2008) reporting of rapid bolus infusions leading to hypotension. It is also important for the nurse to be aware of the potential drug interactions of digoxin toxicity, warfarin toxicity, quinidine toxicity, felcainide toxicity, procainamide toxicity, phenytoin toxicity and increased cyclosporine levels. The doses of these drugs may need to be decreased when amiodarone is started. (Figa et al., 1994) (Karch, 2009) The nurse should monitor these blood levels and hold the dose and report the problem to the PCP if a problem is noted. The nurse should also be aware that amiodarone can cause an increased T3 level and increased serum reverse T3 level. (Karch, 2009)Upon reviewing the various studies available surrounding amiodarone use in this patient population minimal severe adverse effects were encountered. The studies come from all over the world and come to the same conclusion. Pediatric cardiologists are prescribing amiodarone for their patient’s despite to potential risks. The conclusions to the studies reviewed were that amiodarone is safe and effective for use in infancy and the neonatal period. Although the studies have proven the drug to be safe it still requires caution and close monitoring. The future for nursing in relation to amiodarone is to continue to closely monitor this patient population. Nurses should be able to assess for life-threatening arrhythmias, especially those nurses dealing with a high risk population. They should be able to continuously assess a patient’s cardiac rhythm while they are receiving amiodarone therapy. A nurse should be aware of all of the potentially severe adverse effects and drug interactions and be able to point out any potential problems to the primary caregiver. I anticipate continued research in this area and continued use of amiodarone due to the current studies deeming it safe and effective. Nurses involved in the use of amiodarone should make every effort to stay up to date on the most current information.

Conclusion

Amiodarone use in infants and neonates has been proven to be safe and effective by multiple studies. Although many of the adverse effects listed tend to be severe or lethal they are rare in general, and even more rare in this patient population. Amiodarone is definitely a drug that requires close monitoring in an intensive care setting such as the neonatal intensive care or cardiovascular intensive care units. It also requires a nurse to be able to evaluate the patient’s cardiac rhythm throughout therapy and a nurse that will keep educated on the potential adverse effects. The initial reason for this research was due to the fact that the risks presented by Aschenbrenner & Venable left questions regarding the safety of amiodarone in this patient population. Upon more thorough research it was found that these issues are known, they are rare, and the benefits to the patient population usually outweigh the risks. The use of amiodarone no longer presents such questions, but is still an ongoing issue due to the potentials that are present that require close monitoring and a very competent group of caregivers. The studies conclude that amiodarone is safe and effective for the infant and neonatal patient population. They also support that amiodarone is effective and an appropriate treatment for life-threatening arrhythmias in this patient population.


References

Aschenbrenner, D. S., & Venable, S. J. (2009). Drug therapy in nursing (3rd ed.). Philadelphia, PA: Wolters Kluwer Health / Lippincott Williams & Wilkins.

Etheridge, S. P., Craig, J. E., & Compton, S. J. (2001). Amiodarone is safe and highly effective therapy for supraventricular tachycardia in infants. American Heart Journal, 141(1), 105-110. Retrieved October 3, 2008 from http://www.sciencedirect.com.databases.wtamu.edu:2048/science?_ob=MImg&_imagekey=B6W9H-45SR6R7-T-1&_cdi=6683&_user=952831&_orig=browse&_coverDate=01%2F31% 2F2001&_sk=998589998&view=c&wchp=dGLbVlW-zSkzk&md5=f3561fc5fdbecc080bbf5e453f9898a1&ie=/sdarticle.pdf

Figa, F. H., Gow, R. M., Hamilton, R. M., & Freedom, R. M. (1994). Clinical efficacy and safety of intravenous amiodarone in infants and children. The American Journal of Cardiology, 74(6), 573-577. Retrieved October 3, 2008 from http://www.sciencedirect.com.databases.wtamu.edu:2048/science/article/B6T10-4C76D61-194/2/9bc4cfd27d078061d08b75644cd4e3a5

Haas, N. A., & Camphausen, C. K. (in press). Impact of early and standardized treatment with amiodarone on therapeutic success and outcome in pediatric patients with postoperative tachyarrhythmia. The Journal of Thoracic and Cardiovascular Surgery. Retrieved October 5, 2008, from http://www.sciencedirect.com/science?_ob=GatewayURL&_method=citationSearch&_uoikey=B6WMF-4SRDFM4- 5&_origin=SDEMFRHTML&_version=1&md5=ce0788a11badc2e9708467324ac58c37

Karch, A. M. (2009). 2009 Lippincott’s Nursing drug guide. Philadelphia, PA: Wolters Kluwer Health / Lippincott Williams & Wilkins.

Miller-Hoover, S. R. (2006). Neonatal and Infant tachyarrhythmias: Differentiation and treatment. Newborn and Infant Nursing Reviews, 6(3), 165-174.

Moak, J. P. (2000). Supraventricular tachycardia in the neonate and infant. Progress in Pediatric Cardiology, 11(1), 25-38.

New labeling addresses off-label pediatric use. (2001). Nursing, 31(9), 18.

Rosenthal, D., Chrisant, M. R., Edens, E., Mahoney, L., Carter, C., & Colan, S. et al. (2004). International society for heart and lung transplantation: Practice guidelines for management of heart failure in children. The Journal of Heart and Lung Transplantation, 23(12), 1313-1333.

Weindling, S. N., Saul, J. P., & Walsh, E. P. (1996). Efficacy and risks of medical therapy for supraventricular tachycardia in neonates and infants. American Heart Journal, 131(1), 66-72.

Yildirim, S. V., Tilker, F., Cengiz, N., & Kilicdag, H. (2005). Recurrent supraventricular tachycardia in a newborn treated with amiodarone: is hyperkalemia the apparent cause? [Electronic version] Pediatric Cardiology, 26(6), 879-880.


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