Last update Feb. 7, 2022

Theophylline

Compatible

Safe substance and/or breastfeeding is the best option.

Theophylline is a xanthine derivative chemically similar to caffeine and theobromine. It is used to treat asthma and bronchospasm. It is used as treatment of apnea on premature babies. Oral and intravenous administration every 6 to 8 hours.

It is excreted in human milk in small amounts but it could be clinically significant (Gardner 1987, Reinhardt 1983, Stec 1980, Yurchak 1976).

Except in the case of a newborn who developed irritability and difficulties falling asleep, no problems have been observed in infants whose mothers took it (Yurchak 1976).

Maternal serum levels must be monitored and maintained at 5 - 12 mcg / mL (National Asthma 2004).

Several medical societies, experts and expert consensus, consider the use of this medication to be compatible during breastfeeding. (Middleton 2020, National Asthma Ed. 2004)

American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).

List of WHO essential medicines: compatible with breastfeeding (WHO / UNICEF 2002).

Monitor the appearance of irritability or insomnia in the infant.

Known safer alternatives are preferable, especially during the neonatal period and in the event of prematurity.

Alternatives

  • Albuterol (Safe substance and/or breastfeeding is the best option.)
  • Terbutaline Sulfate (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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Other names

Theophylline is also known as


Theophylline in other languages or writings:

Group

Theophylline belongs to this group or family:

Tradenames

Main tradenames from several countries containing Theophylline in its composition:

List of 33 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 76 %
Molecular weight 180 daltons
Protein Binding 55 %
VD 0.3 - 0.7 l/Kg
pKa 7.8 -
Tmax 1 - 2 hours
T½ 8 - 12 hours
M/P ratio 0.5 - 1.1 -
Theoretical Dose 0.42 - 1.0 mg/Kg/d
Relative Dose 5 - 11 %
Ped.Relat.Dose 3.5 -8.3 %

References

  1. Middleton PG, Gade EJ, Aguilera C, MacKillop L, Button BM, Coleman C, Johnson B, Albrechtsen C, Edenborough F, Rigau D, Gibson PG, Backer V. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020 Feb 6;55(2). pii: 1901208. Abstract Full text (link to original source) Full text (in our servers)
  2. Athavale MA, Maitra A, Patel S, Bhate VR, Toddywalla VS. Development of an in vitro cell culture model to study milk to plasma ratios of therapeutic drugs. Indian J Pharmacol. 2013 Abstract Full text (link to original source) Full text (in our servers)
  3. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  4. National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. None 2004 Full text (link to original source) Full text (in our servers)
  5. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Abstract Full text (link to original source) Full text (in our servers)
  6. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  7. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000 Nov;16(4):319-31. Review. Erratum in: J Hum Lact 2001 Feb;17(1):90. Abstract
  8. Kirsten R, Nelson K, Kirsten D, Heintz B. Clinical pharmacokinetics of vasodilators. Part II. Clin Pharmacokinet. 1998 Abstract
  9. Gardner MJ, Schatz M, Cousins L, Zeiger R, Middleton E, Jusko WJ. Longitudinal effects of pregnancy on the pharmacokinetics of theophylline. Eur J Clin Pharmacol. 1987;32(3):289-95. Abstract
  10. 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 Feb;131(2):66-70. German. Abstract
  11. Stec GP, Greenberger P, Ruo TI, Henthorn T, Morita Y, Atkinson AJ Jr, Patterson R. Kinetics of theophylline transfer to breast milk. Clin Pharmacol Ther. 1980 Sep;28(3):404-8. Abstract
  12. Yurchak AM, Jusko WJ. Theophylline secretion into breast milk. Pediatrics. 1976 Apr;57(4):518-20. Abstract

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