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Chlorpheniramine / dihydrocodeine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Chlorpheniramine / dihydrocodeine / pseudoephedrine is also known as: Coldcough Syrup, Dihydro-CP, Hydro-Tussin DHC, Pancof, Tricof, Uni-Cof

Chlorpheniramine / dihydrocodeine / pseudoephedrine Pregnancy Warnings

Chlorpheniramine/dihydrocodeine/pseudoephedrine has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted with this combination product. There are no controlled data in human pregnancy. In the pregnancy section of the product labeling for Hydro-Tussin DHC, the manufacturer states "This combination product should be given to pregnant women only if clearly needed, especially during the first trimester." However, in the contraindications section of the product labeling, the manufacturer of Hydro-Tussin DHC states that "This product is contraindicated in women who are pregnant." (This may be due to the fact that with conservative use, dihydrocodeine is relatively safe for use in pregnancy. However, if used for prolonged periods or in high doses at term, dihydrocodeine represents a significantly greater risk when used in pregnancy.) The manufacturer further states that the product is "... not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn."

Chlorpheniramine/dihydrocodeine/pseudoephedrine is not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of the maternal opioid use or dose. The Collaborative Perinatal Project monitored 1,070 first trimester exposures and 3,931 exposures which occurred anytime during pregnancy. No evidence was found to suggest a relationship to large categories of malformations. Antihistamine exposure in the first trimester in general was not associated with an increased risk of malformations. Babies born to mothers who have been taking opioids regularly prior to delivery are likely to be physically dependent. Withdrawal signs have included irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. To treat opioid withdrawal symptoms in infants, chlorpromazine 0.7 to 1.0 mg/kg every six hours, phenobarbital 2 mg/kg every six hours, or paregoric 2 to 4 drops/kg every four hours have been used. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.

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Chlorpheniramine / dihydrocodeine / pseudoephedrine Breastfeeding Warnings

There are no data on the excretion of chlorpheniramine into human milk. However, because other antihistamines are excreted into human milk in low concentrations, the manufacturer of chlorpheniramine recommends that caution be used when administering chlorpheniramine to nursing women. There are no data on the excretion of dihydrocodeine into human milk. However, because other opiates (e.g. morphine) are excreted into human milk and because the molecular weight of dihydrocodeine bitartrate is low enough, the presence of dihydrocodeine in the milk would be expected. Pseudoephedrine is excreted into human milk. Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine, or 0.5% to 0.7% of the dose ingested by the mother. There are no reports of adverse effects in infants who were exposed to pseudoephedrine in breast milk. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

There are no data on the excretion of the combination product chlorpheniramine/dihydrocodeine/PSE into human milk. Pseudoephedrine is excreted into human milk.

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References for pregnancy information

  1. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  2. Nelson MA, Forfar JO "Associations between drugs administered during pregnancy and congenital abnormalities of the fetus." Br Med J 1 (1971): 523-7
  3. "Product Information. Hydro-Tussin DHC (chlorpheniramine/dihydrocodeine/PSE)." Ethex Corporation, Saint Louis, MO.
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):

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. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):
  4. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  5. "Product Information. Chlortrimeton (chlorpheniramine)." Schering-Plough, Liberty Corner, NJ.
  6. "Product Information. Hydro-Tussin DHC (chlorpheniramine/dihydrocodeine/PSE)." Ethex Corporation, Saint Louis, MO.
  7. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM "Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers." Br J Clin Pharmacol 18 (1984): 901-6

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