Theophylline Pregnancy and Breastfeeding Warnings

Theophylline is also known as: Aerolate III, Aerolate JR, Asmalix, Bronkodyl, Elixophyllin, Quibron-T, Quibron-T/SR, Respbid, Slo-Bid Gyrocaps, Slo-Phyllin, Slo-Phyllin 125, T-Phyl, Theo-24, Theo-Dur, Theo-Time, Theo-X, TheoCap, Theobid, Theochron, Theoclear LA-130, Theoclear LA-260, Theolair, Theolair-SR, Theovent, Uniphyl

Theophylline Pregnancy Warnings

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 concentrations immediately following birth. In 12 mothers receiving theophylline, at the time of delivery, maternal serum, cord serum, and infant serum theophylline concentrations averaged 10 mcg/mL. Cases of 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 infants serum theophylline level 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. One study has shown an increase in fetal breathing movements when theophylline was ingested by pregnant women at 33 to 38 weeks gestation. Since fetal breathing movements are routinely used to assess fetal status in late gestation, maternal theophylline intake should be taken into account.

Theophylline has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality and teratogenicity. There are no controlled data in human pregnancy. Theophylline is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Theophylline Breastfeeding Warnings

Theophylline is excreted into human milk and may cause irritability or other signs of mild toxicity. The concentration of theophylline in breast milk is approximately equivalent to the maternal serum concentration. The manufacturer states that serious adverse effects in the infant are unlikely unless the mother has toxic serum theophylline concentrations. The American Academy of Pediatrics considers theophylline to be compatible with breast-feeding.

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 administering nursing prior to administration of theophylline to avoid peak milk concentrations.

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