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Chlordiazepoxide / clidinium Pregnancy and Breastfeeding Warnings

Chlordiazepoxide / clidinium is also known as: Chlordinium, Clindex, Librax

Chlordiazepoxide / clidinium Pregnancy Warnings

The Collaborative Perinatal Project reported no association between first trimester use of chlordiazepoxide and congenital malformations. In a prospective study, 2323 patients were exposed to parasympatholytics during the first trimester, 4 of whom took clidinium. A possible correlation between the total group and minor malformations was observed.

Chlordiazepoxide has been assigned to pregnancy category D by the FDA. Chlordiazepoxide crosses the placenta and achieves a maternal:fetal plasma ratio of 1:1. An increased risk of congenital malformations in humans has been associated with the use of chlordiazepoxide in pregnancy, particularly in the first and second trimesters. Chronic use of chlordiazepoxide in later pregnancy has been associated with neonatal withdrawal and a "floppy infant syndrome" consisting of hypotonia, depression, decreased responsiveness, and reluctance to feed. There are no controlled data in human pregnancy. Clidinium has been assigned to pregnancy category C by the FDA. Minor malformations may be associated with clidinium use during the first trimester. There are no controlled data in human pregnancy. Chlordiazepoxide-clidinium should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Chlordiazepoxide / clidinium Breastfeeding Warnings

There are no data on the excretion of chlordiazepoxide-clidinium into human milk. Other benzodiazepines are excreted into human milk and reports of adverse reactions in nursing infants have occurred. Due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug, taking into account the importance of the drug to the mother.

Chlordiazepoxide is expected to pass into milk due to its low molecular weight.

See references

References for pregnancy information

  1. Athinarayanan P, Pierog SH, Nigam SK, Glass L "Chloriazepoxide withdrawal in the neonate." Am J Obstet Gynecol 124 (1976): 212-3
  2. Decancq HG, Jr Bosco JR, Townsend EH, Jr "Chlordiazepoxide in labor. Its effect on the newborn infant." J Pediatr 67 (1965): 836-40
  3. Stirrat GM, Edington PT, Berry DJ "Letter: Transplacental passage of chlordiazepoxide." Br Med J 2 (1974): 729
  4. Hartz SC, Heinonen OP, Shapiro S, Siskind V, Slone D "Antenatal exposure to meprobamate and chlordiazepoxide in relation to malformations, mental development, and childhood mortality." N Engl J Med 292 (1975): 726-8
  5. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  6. "Product Information. Librax (chlordiazepoxide-clidinium)." Valeant Pharmaceuticals, Costa Mesa, CA.
  7. Bitnun S "Possible effect of chlordiazepoxide on the fetus." Can Med Assoc J 100 (1969): 351
  8. Milkovich L, Van Den Berg BJ "Effects of prenatal meprobamate and chlordiazepoxide hydrochloride on human embryonic and fetal development." N Engl J Med 291 (1974): 1268-71
  9. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):
  2. "Product Information. Librax (chlordiazepoxide-clidinium)." Valeant Pharmaceuticals, Costa Mesa, CA.

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