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Medication Update: December 2007

Medication Update is a bi-monthly newsletter of the Pharmacy and Therapeutics Committee for physicians, pharmacists and nurses.

New Formulary Drugs

Idursulfase (Elaprase™)

Idursulfase is used for the treatment of patients with mucopolysaccharidosis, also known as Hunter Syndrome.

Nicardipine (Cardene®)

Nicardipine is used short-tem to control hypertension when intravenous therapy is required. It is currently the only IV calcium channel blocker available. Because it is very irritating to the vein it is recommended that it be used infused via central line if possible. It can be given via peripheral line but it should be used in a more dilute concentration and the IV site should be changed every 12 hours. Nicardipine was approved for addition to the formulary but with restriction to the critical care setting where nitroprusside and labetalol are not reasonable options for a patient.

Insulin glulisine (Apidra®)

Apidra is a rapid-acting form of insulin to be used in patients on a basal-bolus regimen. Apidra was added to the formulary but with restriction to patients that are currently using the drug at home or with approval from endocrine service for patients who have failed other short acting products such as Humalog or Novolog.

Insulin detemir (Levemir®)

Levemir is long acting form of insulin that provides a basal coverage for patients on a basalbolus regimen. Levemir provides an alternative form of insulin for patients who are not controlled with or who cannot use Lantus.

Other Formulary Issues

Enoxaparin

Several dosing changes to enoxaparin use in infants and neonates are recommended after a review of the literature and a medication use evaluation. A retrospective study of enoxaparin found that 91% of CHRMC patients under 5 kg were sub-therapeutic when started on the standard 1 mg/kg every 12 hour dosing. Therefore, It is recommended that we use a 1.5 mg/kg every 12 hour dosing regimen for patients less than 5 kg. This would be a change to a weight based cut-off instead of our previous guidelines that suggested an age cut-off. It is also recommended that patients born at less than 38 weeks gestation and less than 5 kg would be started on an empiric dose of 2 mg/kg every 12 hours.

Desflurane

A trial of desflurane use at CHRMC was undertaken. The results of a trial of were favorable. Wake up time from anesthesia was looked at for several procedures. Wake up times for neurosurgery were much improved which is critical in this subset of patients. Wake up times post tonsillectomy was also improved which resulted in earlier discharges for patients. Because of these results desflurane is added to the formulary with its use to be reviewed in 6 months.

Ketamine

An update to the policy on the use of ketamine by non-anesthesiologists was approved to include the use of ketamine as prescribed by the pain service to treat SCCA patients with chronic pain issues.

FDA Corner

Cefepime (Maxipime)

Cefepime had a 26% higher mortality rate (95% confidence intervals: 8%-49%) compared to other B-lactam antibiotics in a systematic review of 57 randomized-controlled trials. The number of patients needed to treat with comparator drugs in order to prevent one death with cefepime is 50 (33–100) patients. When analyzing just the pediatric studies, no difference in mortality are noted. For more information see: Lancet Infect Dis 2007;7:338-48. or http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cefepime.

Mycophenolate mofetil (Myfortic, Cellcept)

When used during pregnancy, is associated with increased risks of pregnancy loss and congenital malformations (now category D). For more information see: http://www.fda.gov/medwatch/safety/2007/safety07.htm#CellCept2 and http://www.fda.gov/medwatch/safety/2007/safety07.htm#Myfortic.

Nelfinavir mesylate (Viracept)

Nelfinavir contains a potential human carcinogen as an impurity in the manufacturing process. Nelfinavir is not recommended for first-line use in children just starting anti-retroviral therapy or for pregnant women. For more information see: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Viracept.

Respiratory Syncytial Virus

Respiratory Syncytial Virus (RSV) is a seasonal virus which causes respiratory illness in young infants. It effects 90% of infants and children by the age of 2. Approximately 125,000 infants are hospitalized in the U.S. each year for severe RSV. The disease is self limiting for most normal healthy infants. Groups at high risk for severe RSV disease include those with bronchopulmonary dyslpasia, congenital heart disease, preemies, and patients with decreased immune systems.

The virus is spread through contact with infected persons or contaminated surfaces. The infection can enter the body through mucous membranes or inhalation of droplets.

The main symptoms of RSV infection include runny nose, cough, and possibly a fever. Bronchiolitis and pneumonia as well as croup are common manifestations. Some patients may develop otitis media. Nasal aspirates or washes can be used for diagnostic purposes.

The treatment for RSV infections is mainly symptomatic support, IV hydration, oxygen, and monitoring. Bronchodilators may provide some relief of symptoms. Corticosteroids, inhaled or oral, may be useful in severe ventilated patients but probably does not offer much for less severe patients. Aerosolized ribavirin may be helpful if started early in patients with very severe disease but does not alter the course of infection in previously healthy children.

Preventing the virus from spreading is extremely important. Proper hand washing and isolation precautions are essential.

Palivizumab (Synagis) is a monoclonal antibody that can provide passive immunity to RSV. It is administered IM at a dose of 15mg/kg every month. If the IM dose exceeds 1 mL the injection is generally placed in 2 syringes and given at separate injection sites to ease the pain. It can also be given IV if the patient is at risk for bleeding or has little muscle mass.

Indications for palivizumab include:

  • Infants born at <=32 weeks gestation who are <6 months old at the onset of the RSV season.
  • Infants born at 33-35 weeks gestation who are <6 months old at the onset of the RSV season with one of the following risk factors for severe disease:
    • Status post neonatal hospitalization with complications (e.g., mechanical ventilation)
    • Infants at significant social risks, including daycare attendance, homeless mothers, mothers in drug rehabilitation programs,
    • Native American ethnicity
  • Children with conditions that adversely affect respiratory function and who have required daily respiratory medications/ treatments (eg, oxygen, diuretics, corticosteroids, bronchodilators) within the last 6 months and are <2 years of age at the onset of the RSV season. This includes children with congenital heart disease.

It is important to remember that palivizumab is only used to prevent viral infection and is not actually a treatment for the infection.

Zydis does not mean Zyprexa

Zydis is actually a technology that uses freeze dried dosage forms of medications to help the medications dissolve very rapidly with just saliva. It is most often associated with Zyprexa because they use the trademark in the product name but other familiar medications such as Zofran ODT and Maxalt-MLT also use the Zydis technology.

Credits

Editors

  • Renee Freitag, PharmD
  • Eric Harvey, PharmD, MBA, BCPS

P&T Chairs

  • Janet Englund, MD
  • Eric Harvey, PharmD, MBA, BCPS

Address

Children's Hospital and Regional Medical Center
P&T Committee, R-3409
4800 Sand Point Way NE
PO Box 5371/R-3409
Seattle, WA 98105