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Oxtriphylline Pregnancy and Breastfeeding Warnings

Oxtriphylline is also known as: Choledyl, Choledyl SA

Oxtriphylline Pregnancy Warnings

Oxtriphylline (theophylline) has been assigned to pregnancy category C by the FDA. Animal reproductive studies have not been conducted. The use of theophylline during pregnancy has not been associated with teratogenicity. There are no controlled data in human pregnancy. Oxtriphylline or theophylline is only recommended for use during pregnancy when benefit outweighs risk.

The Collaborative Perinatal Project monitored 193 women with first trimester exposure to theophylline or aminophylline and found no increased risk of malformations. Cord serum concentrations and infant serum concentrations have been reported to approximate the mother's serum concentration immediately following birth. In 12 mothers receiving theophylline, maternal serum, cord serum, and infant serum theophylline concentrations averaged 10 mcg/mL at the time of delivery. Jitteriness, irritability, and vomiting have been reported in infants of mothers maintained on theophylline prior to delivery. Apnea has been reported in an infant born after 37.5 weeks gestation to a mother who had been maintained on theophylline throughout pregnancy for asthma. At approximately 48 hours after birth, the infant's serum theophylline concentration was 15 mcg/mL. The infant was placed on theophylline when the concentration measured 2 mcg/mL. Apnea resolved when the theophylline concentration reached 17 mcg/mL. The pharmacokinetics of theophylline have been studied in women during pregnancy. Studies throughout pregnancy have noted a significant decrease in the clearance of theophylline during the third trimester. The clearance was only slightly decreased during the first and second trimester. The plasma protein binding of theophylline also has been shown to decrease in the later stages of pregnancy. It is important to closely monitor the theophylline serum concentration and the patient for signs of toxicity during pregnancy.

Oxtriphylline Breastfeeding Warnings

Oxtriphylline (theophylline) is excreted in human milk. In a study of five women given aminophylline, theophylline was detected in milk with a milk:serum ratio of 0.61 to 0.87. The peak milk concentration occurred between one and three hours after ingestion of the dose. Irritability was reported in one infant whose mother took aminophylline. Adverse effects were not reported in the infants of the other women participating in this study. Exposure to the infant can be minimized by nursing prior to administration of oxtriphylline to avoid peak milk concentrations. The American Academy of Pediatrics considers the use of oxtriphylline to be compatible with breast-feeding. The manufacturer recommends that due to the potential for serious adverse effects 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.

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