Benzyl alcohol, another preservative, has been linked to "a number of neonatal deaths and severe respiratory and metabolic complications in low-birth-weight premature infants." Most drugs have very low levels of benzyl alcohol and are not suspected of causing infant complications, although the [American Academy of Pediatrics] note that "the effects of lower amounts... have not been adequately studied."
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Benzyl alcohol gasping syndrome may occur due to a decrease in glycine conjugation seen in neonates and accumulation of benzoic acid.
Remember from class: Glycine conjugation is decreased in neonates and reaches adult levels at approximately 8 weeks of age. Because of decreased glycine conjugation, benzoic acid can accumulate in newborns given excess benzyl alcohol or benzoic acid.
Benzyl alcohol--> benzoic acid ----> glycine conjugation-----> hippuric acid.
This accumulation of benzoic acid results in the "benzyl alcohol gasping syndrome" with deterioration of multiple organ systems, severe metabolic acidosis and gasping respirations. This is a dose related syndrome and has been reported with doses of benzyl alcohol greater than 99 mg/kg. Because of this syndrome, the FDA now recommends that drugs containing benzyl alcohol or benzoic acid as preservatives should NOT be used in neonatal nurseries.
Therefore, one should USE PRESERVATIVE FREE MEDICATIONS FOR NEONATES.
Remember from class: Glycine conjugation is decreased in neonates and reaches adult levels at approximately 8 weeks of age. Because of decreased glycine conjugation, benzoic acid can accumulate in newborns given excess benzyl alcohol or benzoic acid.
Benzyl alcohol--> benzoic acid ----> glycine conjugation-----> hippuric acid.
This accumulation of benzoic acid results in the "benzyl alcohol gasping syndrome" with deterioration of multiple organ systems, severe metabolic acidosis and gasping respirations. This is a dose related syndrome and has been reported with doses of benzyl alcohol greater than 99 mg/kg. Because of this syndrome, the FDA now recommends that drugs containing benzyl alcohol or benzoic acid as preservatives should NOT be used in neonatal nurseries.
Therefore, one should USE PRESERVATIVE FREE MEDICATIONS FOR NEONATES.
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Drug products containing benzyl alcohol as preservative:
Drug products containing benzyl alcohol as preservative:
Heparin Sodium (Heparin Leo Injection) 1,000 i.u., 5,000 i.u., 25,000 i.u.
Mfr./Distr.: Leo Pharmaceutical Products/Zuellig Pharma. Corp.
1 comment:
here are some of the drugs i know that contain benzyl alcohol...
Solu-Medrol & Solu-Cortef Act-O-Vials...Aeknil 150mg/ml amp and Valium amp...but there are more i suppose..we have to consult the MIMS Annual...;p
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