The Basics
What is Theophylline?
Used to control symptoms caused by lung problems such as asthma, chronic obstructive lung disease (COPD) or other lung problems.
Brand names for Theophylline
Theolair
How Theophylline is classified
Anti-Asthmatic Agents, Bronchodilator Agents
Theophylline During Pregnancy
Theophylline pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Theophylline while pregnant
There are no adequate and well controlled studies in pregnant women. Additionally, there are no teratogenicity studies in non-rodents (e.g., rabbits). Theophylline was not shown to be teratogenic in CD-1 mice at oral doses up to 400 mg/kg, approximately 2.0 times the human dose on a mg/m2 basis or in CD-1 rats at oral doses up to 260 mg/kg, approximately 3.0 times the recommended human dose on a mg/m2 basis. At a dose of 220 mg/kg, embryotoxicity was observed in rats in the absence of maternal toxicity.
Taking Theophylline While Breastfeeding
What are recommendations for lactation if you're taking Theophylline?
An expert panel considers use of theophylline to be acceptable during breastfeeding.[1] Maternal theophylline use may occasionally cause stimulation and irritability and fretful sleep in infants. Newborn and especially preterm infants are most likely to be affected because of their slow elimination and low serum protein binding of theophylline. There is no need to avoid theophylline products; however, keep maternal serum concentrations in the lower part of the therapeutic range and monitor the infant for signs of theophylline side effects. Infant serum theophylline concentrations can help to determine if signs of agitation are due to theophylline. Avoiding breastfeeding for an 2 hours after intravenous or 4 hours after an immediate-release oral theophylline product can decrease the dose received by the breastfed infant. When theophylline is given as an oral sustained-release product, timing of nursing with respect to the dose is of little or no benefit.
Maternal / infant drug levels
An expert panel considers use of theophylline to be acceptable during breastfeeding.[1] Maternal theophylline use may occasionally cause stimulation and irritability and fretful sleep in infants. Newborn and especially preterm infants are most likely to be affected because of their slow elimination and low serum protein binding of theophylline. There is no need to avoid theophylline products; however, keep maternal serum concentrations in the lower part of the therapeutic range and monitor the infant for signs of theophylline side effects. Infant serum theophylline concentrations can help to determine if signs of agitation are due to theophylline. Avoiding breastfeeding for an 2 hours after intravenous or 4 hours after an immediate-release oral theophylline product can decrease the dose received by the breastfed infant. When theophylline is given as an oral sustained-release product, timing of nursing with respect to the dose is of little or no benefit.
Possible effects of Theophylline on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Theophylline
Terbutaline.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg.htm
2. Stec GP, Greenberger P, Ruo TI et al. Kinetics of theophylline transfer to breast milk. Clin Pharmacol Ther. 1980;28:404-8. PMID: 7408400
3. Yurchak AM, Jusko WJ. Theophylline secretion into breast milk. Pediatrics. 1976;57:518-25. PMID: 1264548
4. Gardner MJ, Schatz M, Cousins L et al. Longitudinal effects of pregnancy on the pharmacokinetics of theophylline. Eur J Clin Pharmacol. 1987;31:289-95. PMID: 3595701
5. Reinhardt D, Richter O, Brandenburg G. [Pharmacokinetics of drugs from the breast-feeding mother passing into the body of the infant, using theophylline as an example]. Monatsschr Kinderheilkd. 1983;131:66-70. PMID: 6843559
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
