Hydroxyprogesterone Pregnancy and Breastfeeding Warnings

Hydroxyprogesterone is also known as: Delta-Lutin, Duralutin, Hylutin, Hyprogesterone, Makena, Prodrox

Hydroxyprogesterone Pregnancy Warnings

Hydroxyprogesterone has been assigned to pregnancy category B by the FDA. There are no adequate and well controlled studies of hydroxyprogesterone use in women during the first trimester of pregnancy. Data from a vehicle (placebo)-controlled clinical trial of 310 pregnant women who received hydroxyprogesterone at weekly doses of 250 mg by intramuscular injection in their second and third trimesters, as well as long-term (2 to 5 years) follow-up safety data on 194 of their infants, did not did not demonstrate any teratogenic risks to infants from in utero exposure. Hydroxyprogesterone is only recommended for use during pregnancy when benefit outweighs risk.

Hydroxyprogesterone Breastfeeding Warnings

Detectable amounts of progestins have been identified in the milk of mothers receiving progestin treatment. Many studies have found no adverse effects of progestins on breastfeeding performance, or on the health, growth, or development of the infant. There is no indication for hydroxyprogesterone after delivery. Discontinue hydroxyprogesterone at 37 weeks of gestation or upon delivery.

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