Document Detail

Hospital morphine preparation for abstinence syndrome in newborns exposed to buprenorphine or methadone.
MedLine Citation:
PMID:  18008179     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: This study was undertaken to evaluate the adequacy of a hospital formulated oral morphine preparation for management of neonatal abstinence syndrome (NAS) and to compare clinical features in infants exposed to methadone or buprenorphine in utero.
METHOD: Between October 1998 and October 2004 all infants born to mothers treated with buprenorphine or methadone during pregnancy were enrolled into this prospective study. Morphine hydrochloride solution (0.2 mg/ml) was prepared without preservatives under a flow laminar air box (class 100).
MEAN OUTCOME MEASURE: Morphine solution: quantitative and qualitative HPLC analysis and microbiological study at regular intervals during storage at 4 degrees C for 6 months. Maternal characteristics: age, opiate dose during pregnancy. Neonatal characteristics: gestational age at delivery, birth weight, Lipsitz scores. Morphine dose: daily morphine dose, maximum morphine dose, duration of NAS, and duration of treatment required to achieve stable Lipsitz scores below 4.
STATISTICS: Kruskal-Wallis test for comparison of median values.
RESULTS: Microbiological and HPLC analysis showed that the morphine preparation remained stable for 6 months at 4 degrees C. Nine methadone-exposed infants and 13 buprenorphine-exposed infants were included in the study. All infants presented NAS requiring treatment with the morphine solution. Lipsitz scores at birth were significantly different in the methadone and buprenorphine groups (P < 0.05). The methadone group required significantly higher doses of morphine preparation than the buprenorphine group during the first 38 days of treatment (P < 0.05): 0.435 +/- 0.150 mg/kg/day vs. 0.257 +/- 0.083 mg/kg/day.
CONCLUSION: This hospital morphine solution is adequate for management of NAS. Preparations showed good stability and doses could be adjusted with a margin of 0.02 mg. The onset of NAS occurred within 24 h after birth in methadone-exposed infants (range 6-24 h) and within 48 h after birth in buprenorphine-exposed infants (range 24-168 h). Due to the possibility of delayed onset of NAS up to 7 days, infants born to mothers treated with buprenorphine should be kept in the hospital for an appropriate surveillance period. Treatment time was significantly longer (45 vs. 28 days) and the mean morphine doses were higher (1.7 fold) in methadone-exposed than buprenorphine-exposed infants.
Nathalie Colombini; Riad Elias; Muriel Busuttil; Myriam Dubuc; Marie-Ange Einaudi; Martine Bues-Charbit
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Publication Detail:
Type:  Journal Article     Date:  2007-11-16
Journal Detail:
Title:  Pharmacy world & science : PWS     Volume:  30     ISSN:  0928-1231     ISO Abbreviation:  Pharm World Sci     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-04-17     Completed Date:  2008-10-23     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  9307352     Medline TA:  Pharm World Sci     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  227-34     Citation Subset:  IM    
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MeSH Terms
Buprenorphine / adverse effects*
Chromatography, High Pressure Liquid
Drug Contamination
Drug Stability
Infant, Newborn
Methadone / adverse effects*
Morphine / administration & dosage*,  therapeutic use*
Narcotic Antagonists / adverse effects*
Narcotics / administration & dosage*,  adverse effects,  therapeutic use*
Neonatal Abstinence Syndrome / drug therapy*
Pharmaceutical Solutions
Prospective Studies
Reg. No./Substance:
0/Narcotic Antagonists; 0/Narcotics; 0/Pharmaceutical Solutions; 40D3SCR4GZ/Buprenorphine; 76I7G6D29C/Morphine; UC6VBE7V1Z/Methadone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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