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Bendroflumethiazide / nadolol Pregnancy and Breastfeeding Warnings

Bendroflumethiazide / nadolol is also known as: Corzide, Corzide 40/5, Corzide 80/5

Bendroflumethiazide / nadolol Pregnancy Warnings

Bendroflumethiazide has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been performed. There are no controlled data in human pregnancy. Some retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. Nadolol has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryo- and fetotoxicity in rabbits, but not in rats or hamsters, after dosages 5 to 10 times the maximum recommended human dosage (on a mg per kg basis). There are no controlled data in human pregnancy. Bendroflumethiazide-nadolol should only be given during pregnancy when there are no alternatives and benefits outweigh risk.

See references

Bendroflumethiazide / nadolol Breastfeeding Warnings

Bendroflumethiazide and nadolol are excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Goldman JA, Neri A, Ovadia J, Eckerling B, Vries A, de "Effect of chlorothiazide on intravenous glucose tolerance in pregnancy." Am J Obstet Gynecol 105 (1969): 556-60
  2. "Product Information. Corgard (nadolol)." Bristol-Myers Squibb, Princeton, NJ.
  3. "Product Information. Corzide (bendroflumethiazide-nadolol)" Bristol-Myers Squibb, Princeton, NJ.
  4. Finnerty FA "Thiazide and neonatal thrombocytopenia." N Engl J Med 271 (1964): 160-1
  5. Harley JD, Robin H, Robertson SE "Thiazide-induced neonatal haemolysis?" Br Med J 1 (1964): 696-7
  6. Lammintausta R, Erkkola R, Eronen M "Effect of chlorthiazide treatment on renin-aldosterone system during pregnancy." Acta Obstet Gynecol Scand 57 (1978): 389-92
  7. Lindheimer MD, Katz AI "Sodiuim and diuretics in pregnancy." N Engl J Med 288 (1973): 891-4
  8. Mulley BA, Parr GD, Pau WK, Rye RM, Mould JJ, Sidle NC "Placental transfer of chlorthalidone and its elimination in maternal milk." Eur J Clin Pharmacol 13 (1978): 129-31
  9. Zuspan FP, Bell JD, Barnes AC "Balance-ward and double-blind diuretic studies during pregnancy." Obstet Gynecol 16 (1960): 543-9
  10. Garnet JD "Placental transfer of chlorothiazide." Obstet Gynecol 21 (1963): 123-5
  11. Minkowitz S, Soloway HB, Hall JE, Yermakov V "Fatal hemorrhagic pancreatitis following chlorothiazide administration in pregnancy." Obstet Gynecol 24 (1964): 337-42
  12. Blayac JP, Ribes G, Buys D, Puech R, Loubatieres-Mariani MM "Effects of a new benzothiadiazine derivative, LN 5330, on insulin secretion." Arch Int Pharmacodyn Ther 253 (1981): 154-63
  13. Rodriguez SU, Sanford LL, Hiller MC "Neonatal thrombocytopenia associated with ante-partum administration of thiazide drugs." N Engl J Med 270 (1964): 881-4
  14. Miller ME, Cohn RD, Burghart PH "Hydrochlorothiazide disposition in a mother and her breast-fed infant." J Pediatr 101 (1982): 789-91
  15. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  16. Leikin SL "Thiazide and neonatal thrombocytopenia." N Engl J Med 271 (1964): 161
  17. Pritchard JA, Walley PJ "Severe hypokalemia due to prolonged administration of chlorothiazide during pregnancy." Am J Obstet Gynecol 81 (1961): 1241-4
  18. "Product Information. Naturetin (bendroflumethiazide)" Apothecon Inc, Princeton, NJ.
  19. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  20. Watt JD "Oral diuretics in pregnancy toxaemia." Br Med J 1 (1960): 1807
  21. Jerkner K, Kutti J, Victorin L "Platelet counts in mothers and their newborn infants with respect to ante-partum administration of oral diuretics." Acta Med Scand 194 (1973): 473-5
  22. Shoemaker ES, Gant NF, Madden JD, MacDonald PC "The effect of thiazide diuretics on placental function." Tex Med 69 (1973): 109-15
  23. Crosland DM, Flowers CE "Chlorothiazide and its relationship to neonatal jaundice." Obstet Gynecol 22 (1963): 500-4
  24. Gray MJ "Use and abuse of thiazides in pregnancy." Clin Obstet Gynecol 11 (1968): 568-78
  25. Tatum HJ, Waterman EA "The prophylactic and therapeutic use of the thiazides in pregnancy." GP 24 (1961): 101-5
  26. Anderson GG, Hanson TM "Chronic fetal bradycardia: possible association with hypokalemia." Obstet Gynecol 44 (1974): 896-8
  27. Fox RE, Marx C, Stark AR "Neonatal effects of maternal nadolol therapy." Am J Obstet Gynecol 152 (1985): 1045-6

References for breastfeeding information

  1. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  2. "Product Information. Corgard (nadolol)." Bristol-Myers Squibb, Princeton, NJ.
  3. "Product Information. Corzide (bendroflumethiazide-nadolol)" Bristol-Myers Squibb, Princeton, NJ.
  4. Mulley BA, Parr GD, Pau WK, Rye RM, Mould JJ, Sidle NC "Placental transfer of chlorthalidone and its elimination in maternal milk." Eur J Clin Pharmacol 13 (1978): 129-31
  5. Devlin RG, Duchin KL, Fleiss PM "Nadolol in human serum and breast milk." Br J Clin Pharmacol 12 (1981): 393-6
  6. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  7. Werthmann MW, Krees SV "Excretion of chlorothiazide in human breast milk." J Pediatr 81 (1972): 781-3
  8. "Product Information. Naturetin (bendroflumethiazide)" Apothecon Inc, Princeton, NJ.
  9. Miller ME, Cohn RD, Burghart PH "Hydrochlorothiazide disposition in a mother and her breast-fed infant." J Pediatr 101 (1982): 789-91

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