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Abstract:  17a-hydroxyprogesterone caproate is a naturally occurring metabolite of progesterone that is produced in significant quantities during pregnancy. The demand for 17a hydroxyprogesterone caproate, the lack of a commercially available manufactured form approved by the US Food and Drug Administration, and publication of the results of a large trial to determine the effectiveness of the drug in the prevention of preterm delivery have spawned an increased interest in compounded formulations of the drug. The demand also has necessitated a review of the available literature and of past clinical studies, and a look at present and planned studies. Owing to the importance of this drug in pregnancy and the need for safety, accuracy in potency, and sterility in an intramuscular injection (the most common route of administration), compounding pharmacies must be in compliance with the United States Pharmacopeia Chapter <797> standards should they wish to compound this formulation.

Related Keywords: Dana Reed-Kane, PharmD, FIACP, FACA, FCP, NFPPhC, Karen Kirschbaum, PhD, women, pregnancy, preterm labor, 17a-hydroxyprogesterone caproate, risk factors, progesterone, preterm delivery

Related Categories: LEGAL, STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS, DOSAGE FORMS/DRUG CARRIERS, ENDOCRINOLOGY/HORMONES/ MENOPAUSE/ANDROPAUSE

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