Summary
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 µg of nitrendipine per day, or a relative dose of 0.095%.
References
Warthier DC, Lamping KA, Zyvoloski MG, Gross GJ, Brooks HL (1983) The slow-channel calcium blocking agent, nitrendipine, and coronary blood flow. J Cardiovasc Pharmacol 5: 272–277
White WB, Smith VE, McCabe EJ, Meeran MK (1985) Effects of chronic nitrendipine on casual (office) and 24-hour ambulatory blood pressure. Clin Pharmacol Ther 38: 60–64
Jain AK, McMahon FG, Ryan JR, Maronde R, Vlachakis N, Mroczek W (1984) Efficacy and safety of nitrendipine in patients with severe hypertension: A multiclinic study. J Cardiovasc Pharmacol 6: S1053–1059
Brugmann U, Blasini R, Rudolph W (1984) Antihypertensive and antiischämische Wirkung von Nitrendipine (Bay E 5009). Z Cardiol 73: 24–28
White WB (1984) Management of hypertension during lactation. Hypertension 6: 297–300
Krol GJ, Lettieri JT, Mazzu AL, Burkholder DE, Birkett JP, Taylor RJ, Bon C (1987) Bioequivalence of different nitrendipine tablet dosage formulations. J Cardiovasc Pharmacol 9: S129-S135
Fomon SJ (1974) Infant nutrition, 2nd edn. W. B. Saunders, Philadelphia, pp 23–27
White WB, Andreoli JW, Cohn RD (1985) Alpha-methyldopa disposition in mothers with hypertension and in their breast-fed infants. Clin Pharmacol Ther 37: 387–390
Author information
Authors and Affiliations
Additional information
Presented in part at the 3rd Annual Meeting of the American Society of Hypertension, New York, N.Y., June 24, 1988
Rights and permissions
About this article
Cite this article
White, W.B., Yeh, S.C. & Krol, G.J. Nitrendipine in human plasma and breast milk. Eur J Clin Pharmacol 36, 531–534 (1989). https://doi.org/10.1007/BF00558082
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF00558082