Dyphylline
Risk Factor: CM
Class: RESPIRATORY DRUGS
/ Bronchodilators
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
Animal reproductive studies have not been conducted with dyphylline. This xanthine derivative is closely related to theophylline (see also Theophylline).
No published reports of its use in human pregnancy have been located. In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 97 newborns had been exposed to dyphylline during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Seven (7.2%) major birth defects were observed (four expected), including (observed/expected) cardiovascular defects (3/1), and polydactyly (1/0.3). No anomalies were observed in four other categories of defects (oral clefts, spina bifida, limb reduction defects, and hypospadias) for which specific data were available. Only with cardiovascular defects is there a suggestion of a possible association, but other factors, including the mother's disease, concurrent drug use, and chance may be involved.
Breast Feeding Summary
Dyphylline is excreted into breast milk. In 20 normal lactating women a single 5 mg/kg IM dose produced an average milk:plasma ratio of 2.08 (1). The milk and serum elimination rates were equivalent. Although the drug accumulates in milk, the American Academy of Pediatrics considers dyphylline compatible with breast feeding (2).
References
- Jarboe CH, Cook LN, Malesic I, Fleischaker J. Dyphylline elimination kinetics in lactating women: blood to milk transfer. J Clin Pharmacol 1981;21:40510.
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Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
