Pregnancy Warnings

Chlorpheniramine/codeine/pseudoephedrine Pregnancy and Breast Feeding Warnings

Chlorpheniramine/codeine/pseudoephedrine is also known as: Co-Histine DH, Codahistine-DH Elixir, Codehist DH, Decohistine DH, Dihistine DH, Novadyne DH, Novahistine DH, Phenylhistine DH, Phenylhistine DH Expectorant, Ryna-C

Overview

It is unknown if Chlorpheniramine/Codeine/Pseudoephedrine Liquid can cause harm to the fetus. If you become pregnant while taking Chlorpheniramine/Codeine/Pseudoephedrine Liquid, discuss with your doctor the benefits and risks of using Chlorpheniramine/Codeine/Pseudoephedrine Liquid during pregnancy. Chlorpheniramine/Codeine/Pseudoephedrine Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Chlorpheniramine/Codeine/Pseudoephedrine Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Chlorpheniramine/codeine/pseudoephedrine Pregnancy Warnings

Chlorpheniramine/codeine/pseudoephedrine has been not been formally assigned to a pregnancy category by the FDA. Codeine is the only narcotic analgesic that has shown a statistically significant association with teratogenicity (involving respiratory tract malformations) at the time of this writing. Like other narcotics, codeine rapidly crosses the placenta. Neonatal codeine withdrawal has occurred even in infants whose mothers were taking codeine at cough suppressant doses for as little as ten days prior to delivery. Chlorpheniramine/codeine/pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Chlorpheniramine/codeine/pseudoephedrine Lactation Warnings

There are no data on the excretion of chlorpheniramine into human milk. Codeine is excreted into human milk in small amounts. Several small series and one small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia and cyanosis in the first week of life. Codeine is nevertheless considered compatible with breast-feeding by the American Academy of Pediatrics. 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.

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