Pentoxifylline Pregnancy and Breastfeeding Warnings
Medically reviewed on Dec 18, 2017
Pentoxifylline Pregnancy Warnings
Pentoxifylline has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Pentoxifylline is only recommended for use during pregnancy when benefit outweighs risk.
Pentoxifylline Breastfeeding Warnings
Pentoxifylline and its metabolites are excreted into human milk. Mean pentoxifylline milk concentrations were 73.9 and 35.7 ng/mL at two and four hours after a pentoxifylline dose, respectively. The manufacturer recommends that due to the potential for serious adverse reactions 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.
The excretion of pentoxifylline into breast milk was studied in five healthy women at least six weeks post partum. Following oral administration of a 400 mg dose, pentoxifylline milk concentrations ranged from 27.2 to 163 ng/mL and from less than 10 to 67.4 ng/mL at two and four hours post-dose, respectively. The milk to plasma ratio at four hours post-dose ranged from 0.53 to 1.12 (mean 0.87). Major metabolites of pentoxifylline were also present in milk.
References for pregnancy information
- "Product Information. Trental (pentoxifylline)." Hoechst Marion-Roussel Inc, Kansas City, MO.
References for breastfeeding information
- Witter FR, Smith RV "The excretion of pentoxifylline and its metabolites into human breast milk." Am J Obstet Gynecol 151 (1985): 1094-7
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