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Nitrendipine in human plasma and breast milk.

European journal of clinical pharmacology (1989-01-01)
W B White, S C Yeh, G J Krol
ABSTRACT

To assess the disposition of the dihydropyridine calcium antagonist, nitrendipine, in lactating mothers, we studied three breast-feeding women to determine simultaneous plasma and breast milk concentrations of nitrendipine and its inactive pyridine analog metabolite after both a single 10 mg oral dose and 5 days of continuous therapy (20 mg per day). Nitrendipine was excreted in breast milk at peak concentrations ranging from 4.3 to 6.5 ng/ml 1-2 h after acute dosing while its inactive pyridine metabolite ranged from 6.9 to 11.9 ng.ml-1. After 5 days of dosing, Cmax remained in the same range and the breast milk/whole plasma concentration ratio for nitrendipine was 0.2 to 0.5. On the fourth day of continuous dosing, average concentrations of nitrendipine from 24-h collections of the milk were 1.1 to 3.8 ng.ml-1. Thus, nitrendipine and its metabolite are excreted in very low concentrations in human breast milk. Based on a maternal dose of 20 mg daily, a newborn infant would ingest an average of 1.7 micrograms of nitrendipine per day, or a relative dose of 0.095%.

MATERIALS
Product Number
Brand
Product Description

Supelco
Pyridine solution, certified reference material, 2000 μg/mL in methanol
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Pyridine, puriss. p.a., ACS reagent, reag. Ph. Eur., ≥99.5% (GC)
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Pyridine, ReagentPlus®, ≥99%
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Pyridine, biotech. grade, ≥99.9%
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Pyridine, ACS reagent, ≥99.0%
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Pyridine, suitable for HPLC, ≥99.9%
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Pyridine, ACS reagent, ≥99.0%
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Pyridine, ReagentPlus®, ≥99%
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Pyridine, anhydrous, 99.8%
Supelco
Pyridine, analytical standard
Sigma-Aldrich
Pyridine, ≥99%