Select micronutrients for the preterm neonate.

If premature neonates are not provided with adequate nutrition, they will quickly become deficient because of increased requirements and a lack of nutrient stores to achieve adequate growth. The provision of many of the recommended micronutrients for pediatric and adult patients is challenging in premature neonates because of the limited data surrounding the true needs of premature neonates and the difficulty in assessing adequate serum levels of these nutrients in this patient population. Parenteral and enteral nutrition shortages further complicate providing adequate micronutrients to premature neonates. This review will discuss select micronutrients and their importance to the preterm neonate, with special emphasis on micronutrients with limited evidence and more challenging supplementation and repletion strategies.

Safety in parenteral nutrition compounding.

Parenteral nutrition (PN) compounding is a complex process that requires knowledge and training to ensure the safety and efficacy of this form of nutrition support therapy. Unfortunately, errors and lack of adherence to safe PN compounding recommendations and sterile compounding requirements have resulted in patient injury and death. These lapses in the safe provision of PN have been the result of various factors, including a lack of understanding of PN compatibility, stability, and sterility requirements, as well as drug product shortages and order entry errors. This review will describe the current challenges with the education and training regarding PN compounding, compatibility and stability of PN admixtures, simultaneous administration of nonnutrient medications with PN admixtures, and specific challenges with special populations such as neonates, pediatrics, and those receiving home care.

Enteral and parenteral nutrition considerations in pediatric patients.

PURPOSE: Current clinical practice guidelines on management of enteral nutrition (EN) and parenteral nutrition (PN) in pediatric patients are reviewed. SUMMARY: The provision of EN and PN in pediatric patients poses many unique considerations and challenges. Although indications for use of EN and PN are similar in adult and pediatric populations, recommended EN and PN practices differ for pediatric versus adult patients in areas such as selection of EN and PN formulations, timing of EN and PN initiation, advancement of nutrition support, and EN and PN goals. Additionally, provision of EN and PN to pediatric patients poses unique compounding and medication administration challenges. This article provides a review of current EN and PN best practices and special nutrition considerations for neonates, infants, and other pediatric patients. CONCLUSION: The provision of EN and PN to pediatric patients presents many unique challenges. It is important for pharmacists to keep current with pediatric- and neonatal-specific guidelines on nutritional management of various disease states, as well as strategies to address compounding and medication administration challenges, in order to optimize EN and PN outcomes.

Intravenous fat emulsions reduction for patients with parenteral nutrition-associated liver disease.

OBJECTIVE: To test the hypothesis that implementation of a marked reduction in intravenous fat will result in reversal of parenteral nutrition-associated liver disease (PNALD) in infants. STUDY DESIGN: Prospective study of intravenous fat emulsion reduction in parenteral nutrition to 1 g/kg/d 2 times per week in neonates diagnosed with PNALD. Primary outcome measure was total bilirubin levels compared with gestational age, birth weight, and diagnosis-matched historical controls receiving 3 g/kg/d of intravenous lipids. RESULTS: Intravenous fat emulsion reduction resulted in a significant decline in total bilirubin levels compared with controls. Comparison of growth in the 2 groups was similar. Mild essential fatty acid deficiency was detected in 8 of 31 infants and was reversed with additional days of lipid infusion. No significant adverse events were noted. CONCLUSIONS: An association between intravenous lipid emulsion administration and the development of PNALD seems probable. Use of intravenous fat emulsion reduction is a potential approach to reverse PNALD in young infants. Frequent monitoring of essential fatty acid deficiency is needed with the use of this regimen.

Stability of extemporaneously prepared glycopyrrolate oral suspensions.

PURPOSE: The stability of extemporaneously prepared glycopyrrolate 0.5-mg/mL suspensions was evaluated. METHODS: An oral suspension of glycopyrrolate 0.5 mg/mL was prepared by thoroughly grinding 30 1-mg tablets of glycopyrrolate in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23-25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and 7, 15, 30, 60, and 90 days afterward. After further dilution to an expected concentration of 50 µg/mL with sample diluent, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH on each day of analysis. Taste evaluations were performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: At least 95% of the initial glycopyrrolate remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample. CONCLUSION: Extemporaneously compounded suspensions of glycopyrrolate 0.5 mg/mL in a 1:1 mixture of Ora-Plus/Ora-Sweet or Ora-Plus/Ora-Sweet SF were stable for at least 90 days when stored in amber plastic bottles at room temperature.

Stability of extemporaneously prepared oxandrolone oral suspensions.

PURPOSE: The stability of extemporaneously prepared oxandrolone oral suspensions was studied. METHODS: Oxandrolone oral suspension (1 mg/mL) was prepared using oxandrolone tablets, Ora-Plus, and either Ora-Sweet or Ora-Sweet SF. Three identical samples of each formulation were prepared and stored in 2-oz amber plastic bottles with child-resistant caps at room temperature (23-25 °C). After thorough but gentle shaking by hand to prevent foaming, a 1-mL sample was withdrawn from each of the six bottles, diluted with mobile phase to an expected concentration of 200 µg/mL, and assayed in duplicate by injecting 5 µL into the high-performance liquid chromatography system immediately after preparation and at 7, 14, 35, 60, and 90 days. The samples were examined for any change in color or pH on each day of analysis. The stability of the suspensions was determined by calculating the percentage of the initial oxandrolone concentration remaining on each test day. Stability was defined as the retention of at least 90% of the initial oxandrolone concentration. RESULTS: At least 98% of the original oxandrolone concentration remained in both formulations at the end of the 90-day study period. There was no appreciable change in odor, taste, color, or pH. Both suspensions remained white in color and sweet with no aftertaste throughout the study period. The oxandrolone was easily resuspended with gentle shaking. CONCLUSION: Extemporaneously prepared suspensions of oxandrolone 1 mg/mL in 1:1 mixtures of Ora-Plus and either Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of an extemporaneous alcohol-free melatonin suspension.

PURPOSE: The stability of alcohol-free oral suspensions of melatonin 1 mg/mL, extemporaneously prepared from two commercially available melatonin tablet products, was studied. METHODS: Four 1-mg/mL melatonin suspensions were prepared. Formulations A and B contained 20 crushed 3-mg tablets of melatonin combined with a 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF to produce a volume of 60 mL. Formulations C and D were prepared by crushing 20 combination tablets containing melatonin 3 mg and pyridoxine hydrochloride 10 mg and then combining the powder with a 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF to produce a 60-mL volume. The suspensions were prepared in triplicate and stored at room temperature in amber plastic prescription bottles. Immediately after preparation and on days 7, 15, 30, 60, and 90, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography (HPLC). The samples were also evaluated for any changes in color, odor, and taste. RESULTS: HPLC analysis demonstrated that at least 94% of the initial melatonin concentration in formulations A and B, and at least 98% of that in formulations C and D, remained throughout the 90-day study period. Detectable changes in color, odor, or taste occurred in all of the formulations. CONCLUSION: Extemporaneously prepared, alcohol-free, 1-mg/mL suspensions of melatonin and melatonin-pyridoxine hydrochloride in a 1:1 mixture of Ora-Plus and either Ora Sweet or Ora Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Stability of extemporaneously prepared rifaximin oral suspensions.

PURPOSE: The stability of extemporaneously prepared rifaximin oral suspensions was studied. METHODS: An oral suspension of rifaximin 20 mg/mL was prepared by thoroughly grinding six 200-mg tablets of rifaximin in a glass mortar. Thirty milliliters of Ora-Plus and 30 mL of either Ora-Sweet or Ora-Sweet SF were mixed and added to the powder to make a final volume of 60 mL. Three identical samples of each formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the six bottles with a micropipette immediately after preparation and at 7, 15, 30, and 60 days. After further dilution to an expected concentration of 20 microg/mL with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and pH was tested on each day of analysis. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point and defined as retention of at least 90% of the initial concentration of rifaximin. RESULTS: At least 99% of the initial rifaximin remained throughout the 60-day study period in both preparations. There were no detectable changes in color, odor, taste, or pH and no visible microbial growth in any sample. CONCLUSION: Extemporaneously prepared suspensions of rifaximin 20 mg/mL in 1:1 mixtures of Ora-Plus with either Ora-Sweet or Ora-Sweet SF were stable for at least 60 days when stored in 2-oz amber plastic bottles at room temperature.

Penicillin prophylaxis in children with sickle cell disease.

Children who have sickle cell disease and are under the age of five years are at increased risk of life-threatening pneumococcal infection due to absent or non-functional spleens and a decreased immune response. To prevent pneumococcal infection, the American Academy of Pediatrics recommends the use of penicillin prophylaxis in children with sickle cell disease under the age of five and in older children who have had a previous severe pneumococcal infection or have functional/surgical asplenia. These recommendations are based on two landmark studies, the first evaluating the effectiveness of penicillin prophylaxis and the second evaluating the duration of prophylaxis. Although the mortality rate from infection has been reduced following penicillin prophylaxis, altered immunologic response and penicillin-resistant S. pneumoniae remain a concern. This paper will review the literature that supports the use of penicillin prophylaxis, potential problems associated with prolonged therapy and recommendations for prophylaxis.

Stability of 70% alcohol solutions in polypropylene syringes for use in ethanol-lock therapy.

PURPOSE: The stability of 70% alcohol solutions in two diluents stored at 23-25 degrees C over 14 days in two brands of polypropylene syringes was studied. METHODS: A 70% alcohol solution was aseptically prepared by adding Dehydrated Alcohol Injection, USP, to Sterile Water for Injection, USP (SWI), in an evacuated i.v. bag. This process was repeated with Bacteriostatic Water for Injection, USP (BWI). Identical 3-mL samples of each of the two solutions were drawn into 10-and 12-mL syringes (each a different brand) and stored at 23-25 degrees C. The stability of the samples was analyzed with high-performance liquid chromatography immediately after preparation and at 3, 7, and 14 days. RESULTS: At least 96% of the initial concentration of alcohol remained throughout the 14-day study period in all syringes. There were no detectable changes in color or volume and no visible evidence of precipitation or microbial growth in any sample. CONCLUSION: Extemporaneously prepared 70% alcohol solutions in SWI or BWI were stable for at least 14 days at 23-25 degrees C in two brands of polypropylene syringes.

Stability of vecuronium in sterile water for injection stored in polypropylene syringes for 21 days.

PURPOSE: The stability of vecuronium bromide 1 mg/mL in preservative-free sterile water for injection for up to 21 days was studied. METHODS: A vecuronium bromide 1-mg/mL solution was prepared by diluting 15 vials of 10-mg Vecuronium Bromide for Injection, USP, powder with preservative-free sterile water for injection and adding the solution to an evacuated i.v. bag. Identical 10-mL volumes of the solution were prepared and stored at 23-25 or 3-5 degrees C in polypropylene syringes. The stability of vecuronium was analyzed in triplicate with stability-indicating high-performance liquid chromatography immediately after preparation of solutions and at 3, 7, 14, and 21 days. The samples were also inspected for volume and color change and for visible precipitation and microbial growth. RESULTS: The percentage of the initial vecuronium bromide concentration remaining at each time point was greater than 100% at both 23-25 and 3-5 degrees C. There were no detectable changes in volume or color and no precipitation or visible microbial growth. CONCLUSION: Vecuronium bromide in an extemporaneously prepared solution in preservative-free sterile water for injection was stable for at least 21 days at 23-25 or 3-5 degrees C.

Stability of partial doses of omeprazole-sodium bicarbonate oral suspension.

BACKGROUND: Omeprazole-sodium bicarbonate powder for oral suspension has recently been marketed. The manufacturer provides no information regarding the acceptability of using partial doses and recommends that the reconstituted suspension be administered immediately after preparation. OBJECTIVES: To determine the stability of the powder for oral suspension over 45 days, evaluate the stability of a partial dose (<20 mg) following exposure to Simulated Gastric Fluid USP (SGF) over 2 hours, and determine the feasibility of administering the suspension through neonatal and pediatric nasogastric feeding tubes compared with lansoprazole. METHODS: Three identical samples of omeprazole-sodium bicarbonate suspension 2 mg/mL were stored in the refrigerator (3-5 degrees C) and assayed by high-performance liquid chromatography immediately after preparation and at 7, 15, 30, and 45 days. Stability of a 1 mg/kg dose with an estimated volume of SGF for a simulated 12.7 kg pediatric patient was determined in triplicate over 2 hours at 37 degrees C. The ability to administer a typical dose of omeprazole suspension and lansoprazole suspension (microgranules and water compounded from lansoprazole oral disintegrating tablets) was assessed in triplicate using 3 different sizes of neonatal/pediatric nasogastric feeding tubes. RESULTS: At least 98% of the initial concentration of omeprazole remained throughout the 45 day study period in all suspensions. The suspension maintained at least 93% of the initial concentration following exposure to SGF for 2 hours. The lansoprazole bead mixture partially clogged the 6 French feeding tube and completely clogged the 5 French feeding tube. The omeprazole-sodium bicarbonate suspension was easily administered through all 3 sizes of neonatal/pediatric feeding tubes. CONCLUSIONS: Omeprazole-sodium bicarbonate suspension 2 mg/mL prepared from 20 mg packets was stable for at least 45 days when stored at 3-5 degrees C. A partial dose of 12.7 mg was stable following exposure to SGF for 2 hours at 37 degrees C. This suspension can be easily administered through 5, 6, and 8 French neonatal/pediatric feeding tubes and, when taking time and ease of preparation into account, it is cost competitive with simple omeprazole suspension.

Stability of an extemporaneously prepared alcohol-free phenobarbital suspension.

PURPOSE: The physical and chemical short-term stability of alcohol-free, oral suspensions of phenobarbital 10 mg/mL prepared from commercially available tablets in both a sugar and a sugar-free vehicle was assessed at room temperature. METHODS: Phenobarbital oral suspension 10 mg/mL was prepared by crushing 10 60-mg tablets of phenobarbital with a mortar and pestle. A small amount of Ora-Plus was added to the phenobarbital powder to sufficiently wet the particles. A 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF was combined with the phenobarbital powder to produce a final volume of 60 mL. Three identical samples of each of the two different formulations were prepared and stored at room temperature in 2-oz amber plastic bottles. Immediately after preparation and at 15, 30, 60, and 115 days, the samples were assayed in duplicate by stability-indicating high-performance liquid chromatography. The samples were tasted and inspected for color and odor changes. The percent of the initial concentration remaining at each study time for each phenobarbital suspension was determined. Stability was defined as the retention of at least 90% of the initial concentration. RESULTS: There were no detectable changes in color, odor, and taste and no visible microbial growth in any sample. At least 98% of the initial phenobarbital concentration remained throughout the 115-day study period in both preparations. CONCLUSION: An extemporaneously prepared alcohol-free suspension of phenobarbital 10 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF was stable for at least 115 days when stored in 2-oz amber plastic bottles at room temperature.

Otitis media: review of the 2004 treatment guidelines.

OBJECTIVE: To review the 2004 treatment guidelines provided by the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) regarding the treatment of otitis media in pediatric patients. DATA SOURCES: A MEDLINE search, restricted to English-language articles about pediatric patients, was conducted (1966-May 2005) using the key words acute otitis media (AOM), guideline, observation therapy, and vaccination. Additional references were located through review of the bibliographies of cited articles. STUDY SELECTION AND DATA EXTRACTION: Studies related to the fundamental basis of the updated guidelines and articles addressing current issues related to otitis media infection were included. DATA SYNTHESIS: Otitis media affects many children in the US. Concerns have been raised about the proper treatment of AOM in the face of increasing drug resistance among primary pathogens responsible for infection. Some countries have chosen to observe patients for a designated period of time prior to initiation of antibiotic therapy. The AAP and AAFP have updated the treatment guidelines for otitis media to include the option of observation therapy, recommendations for dosing of various antibiotic regimens and their place in therapy, and the importance of initial pain management. CONCLUSIONS: Updated treatment guidelines for otitis media have been developed in an effort to properly treat children while decreasing current resistance rates for common organisms that cause AOM. In the future, the therapeutic outcomes of observation therapy related to both the incidence of drug resistance and the possibility of increased complications related to otitis media will need to be evaluated in the US.