Local Anesthetic
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Even though no studies describing the use of pramoxine during animal or human pregnancy have been located (1,2), since symptomatic hemorrhoids occur frequently in pregnancy, products containing pramoxine probably have been used during gestation. Because there is insignificant systemic absorption, there does not appear to be a risk to the embryo or fetus from pramoxine.
FETAL RISK SUMMARY
Pramoxine is a local anesthetic used for topical anesthesia. It is administered either alone or combined with hydrocortisone or other ingredients for the temporary relief of pain and itching secondary to minor skin irritations resulting from burns, sunburn, cuts, abrasions, insect bites, and hemorrhoids and other anorectal disorders. Pramoxine is typically formulated in a 1% concentration. Animal reproduction studies with pramoxine have not been conducted.
The molecular weight of pramoxine (about 294 for the free base) is low enough to cross the placenta, but the amount, if any, that is absorbed after topical administration into the systemic circulation is unknown. A 1985 review stated that pramoxine and similar anorectal products were not absorbed (1). However, even if some were absorbed systemically, the maternal plasma concentration would be very low, thus the amount available for transfer to the embryo or fetus should be negligible.
BREASTFEEDING SUMMARY
No studies describing the use of pramoxine during lactation have been located. The molecular weight of the free base (about 294) is low enough for excretion into breast milk, but the drug is not thought to be absorbed (1). Even if some absorption does occur, the amount in the maternal plasma should be very low so that little, if any, drug would appear in milk. The risk to a nursing infant is probably nil.
References
1.Lewis JH, Weingold AB, The Committee on FDA-Related Matters, American College of Gastroenterology. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol 1985;80:912–23.
2.Friedman JM. Teratogen update: anesthetic agents. Teratology 1988;37:69–77.