Document Detail

Excretion of loratadine in human breast milk.
MedLine Citation:
PMID:  2966185     Owner:  NLM     Status:  MEDLINE    
The excretion of loratadine, a new nonsedating antihistamine, into human breast milk was studied in six lactating nonpregnant volunteers. Each volunteer received one 40-mg loratadine capsule. Milk and blood were collected before and at specified times (to 48 hours) after dosing. Plasma and milk loratadine concentrations were determined by a specific radioimmunoassay, and those of an active but minor metabolite, descarboethoxyloratadine, by high performance liquid chromatography (HPLC). Breast milk concentration-time curves of both loratadine and descarboethoxyloratadine paralleled the plasma concentration-time curves. For loratadine, the plasma Cmax was 30.5 ng/mL at 1.0 hour after dosing and the milk Cmax was 29.2 ng/mL in the 0 to 2 hour collection interval. Through 48 hours, the loratadine milk-plasma AUC ratio was 1.2 and 4.2 micrograms of loratadine was excreted in breast milk, which was 0.010% of the administered dose. For descarboethoxyloratadine, the plasma Cmax was 18.6 ng/mL at 2.2 hours after dosing, whereas the milk Cmax was 16.0 ng/mL, which was in the 4 to 8-hour collection interval. Through 48 hours, the mean milk-plasma descarboethoxyloratadine AUC ratio was 0.8 and a mean of 6.0 micrograms of descarboethoxyloratadine (7.5 micrograms loratadine equivalents) were excreted in the breast milk, or 0.019% of the administered loratadine dose. Thus, a total of 11.7 micrograms loratadine equivalents or 0.029% of the administered dose were excreted as loratadine and its active metabolite. A 4-kg infant ingesting the loratadine and descarboethoxyloratadine excreted would receive a dose equivalent to 0.46% of the loratadine dose received by the mother on a mg/kg basis.(ABSTRACT TRUNCATED AT 250 WORDS)
J Hilbert; E Radwanski; M B Affrime; G Perentesis; S Symchowicz; N Zampaglione
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  28     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  1988 Mar 
Date Detail:
Created Date:  1988-06-09     Completed Date:  1988-06-09     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  234-9     Citation Subset:  IM    
Pharmaceutical Research Division, Schering Corporation, Bloomfield, New Jersey 07003.
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MeSH Terms
Cyproheptadine / analogs & derivatives*,  metabolism,  pharmacokinetics
Histamine Antagonists / metabolism*,  pharmacokinetics
Milk, Human / metabolism*
Piperidines / analysis*,  pharmacokinetics
Pyridines / analysis*,  pharmacokinetics
Reg. No./Substance:
0/Histamine Antagonists; 0/Piperidines; 0/Pyridines; 129-03-3/Cyproheptadine; 79794-75-5/Loratadine; FVF865388R/desloratadine

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