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Available published data on the use of Ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to Ursodiol occurred in the second and third trimester of pregnancy. In animal reproduction studies, Ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. No adverse effects on embryo-fetal development were observed with oral administration of Ursodiol to pregnant rats and rabbits during organogenesis at doses up to 22 and 7 times, respectively, the maximum recommended human dose (based on body surface area). Ursodiol is naturally present in human milk. There are no reports of adverse effects of Ursodiol on the breastfed child, but the reports are extremely limited. There are no data on the effects of Ursodiol on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ursodiol and any potential adverse effects on the breastfed child from Ursodiol or from the underlying maternal condition. The safety and effectiveness of Ursodiol in pediatric patients have not been established. There have been no reports of accidental or intentional overdosage with Ursodiol. Single oral doses of Ursodiol at 10 g/kg in mice and dogs, and 5 g/kg in rats were not lethal. A single oral dose of Ursodiol at 1. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters. Ursodiol tablets, USP 250 mg is available as a film-coated tablet for oral administration. Ursodiol tablets, USP 500 mg is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white or almost white powder consisting of crystalline particles freely soluble in alcohol and glacial acetic acid, sparingly soluble in chloroform, slightly soluble in ether, acetone, methylene chloride and practically insoluble in water. The chemical name of Ursodiol is 3,7?-dihydroxy-5?-cholan-24-oic (C 24 H 40 O 4 )., best legal steroids for muscle growth. Ursodiol has a molecular weight of 392. Its structure is shown below. Inactive ingredients: Sodium Starch Glycolate, Povidone, Sodium Lauryl Sulfate, Tromethamine, Microcrystalline Cellulose, Polyethylene Glycol 3350, Magnesium Stearate, Opadry Clear YS-1-7006, Purified Water. Ursodiol — Clinical Pharmacology. Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool.
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