Vitamin/Gastrointestinal Agent (Stimulant)
PREGNANCY RECOMMENDATION: No Human Data—No Relevant Animal Data
BREASTFEEDING RECOMMENDATION: No Human Data—Potential Toxicity
PREGNANCY SUMMARY
No reports describing the use of dexpanthenol in human pregnancy have been located. The absence of animal and human pregnancy experience prevents an assessment of the embryo–fetal risk. The potential dose over a 24-hour period for postoperative adynamic ileus (500—2500 mg) ranges from 50 to 250 times the U.S. recommended daily allowance in pregnancy (10 mg) for pantothenic acid. Although a 1982 review (1) recommended dexpanthenol for functional constipation in pregnant women, without providing any data in pregnancy, the safest course is to avoid the drug in pregnancy and certainly in the 1st trimester. Increased fluid intake and a high fiber diet are still the best way to decrease constipation in pregnancy (2).
FETAL RISK SUMMARY
Dexpanthenol is administered by IM or IV injection to prevent paralytic ileus, for the treatment of intestinal atony causing abdominal distention, and for postoperative or postpartum retention of flatus, or delay in resumption of intestinal motility. It also is used topically for the treatment of minor skin disorders. Dexpanthenol, the alcoholic analogue of d-pantothenic acid, is a prodrug that is converted in vivo to pantothenic acid, a B complex vitamin. (See Pantothenic Acid.) The vitamin is a precursor of coenzyme A, the cofactor for enzyme-catalyzed reactions involving the transfer of acetyl groups. The plasma elimination half-life and protein binding have not been reported (3).
Animal reproduction studies have not been conducted with dexpanthenol. Neither have animal studies been performed for carcinogenicity, mutagenicity, or impairment of fertility (3).
Studies describing the placental crossing of dexpanthenol have not been located. The molecular weight (about 205) is low enough that exposure of the embryo and fetus should be expected. Moreover, the active metabolite, pantothenic acid, is required for good health and crosses the placenta to the fetus (see Pantothenic Acid).
BREASTFEEDING SUMMARY
No studies describing the use of dexpanthenol during human lactation have been located. The molecular weight (about 205) is low enough that excretion into breast milk should be expected. The active metabolite, pantothenic acid, is excreted into milk. (See Pantothenic Acid.) The U.S. recommended daily allowance during lactation has not been established for pantothenic acid, but the potential dose of dexpanthenol is very high. (See Pregnancy Summary.). Although most of the dexpanthenol dose should be converted to the B vitamin, excretion of unmetabolized prodrug could potentially cause colic and diarrhea in a nursing infant.
References
1.Hanck AB, Goffin H. Dexpanthenol (Ro 01-4709) in the treatment of constipation. Acta Vitaminol Enzymol 1982;4:87–97.
2.Nolan TE, Schilder JM. Lower gastrointestinal tract disorders. Clinical Updates in Women’s Health Care. Am Coll Obstetricians Gynecologists 2006;5(1):5.
3.Product information. Ilopan. Adria Laboratories, 1989.