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Nitrendipine in human plasma and breast milk
1Section of Hypertension and Vascular Diseases, University of Connecticut School of Medicine, Farmington.
European Journal of Clinical Pharmacology
|January 1, 1989
Summary
Nitrendipine and its metabolite are excreted in low concentrations in breast milk. A newborn infant ingests a minimal relative dose of 0.095% from maternal nitrendipine therapy.
Area of Science:
- Pharmacology
- Neonatal Medicine
- Maternal Health
Background:
- Dihydropyridine calcium antagonists like nitrendipine are used to treat hypertension.
- Understanding drug transfer into breast milk is crucial for nursing mothers.
Purpose of the Study:
- To quantify nitrendipine and its metabolite levels in breast milk and plasma of lactating women.
- To determine the infant's potential exposure to nitrendipine via breast milk.
Main Methods:
- Three lactating women received either a single 10 mg oral dose or 20 mg daily for 5 days.
- Simultaneous plasma and breast milk samples were analyzed for nitrendipine and its metabolite.
- Milk-to-plasma concentration ratios and infant daily intake were calculated.
Main Results:
- Peak nitrendipine in milk ranged from 4.3-6.5 ng/ml; metabolite ranged from 6.9-11.9 ng/ml.
- Breast milk/plasma ratio for nitrendipine was 0.2-0.5 after 5 days.
- Average 24-hour milk concentration of nitrendipine was 1.1-3.8 ng/ml on day 4.
Conclusions:
- Nitrendipine and its metabolite are excreted in very low concentrations in human breast milk.
- Infant exposure to nitrendipine is minimal, with a relative dose of approximately 0.095% of the maternal dose.