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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 ). 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. Oral administration of Ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease. In addition to the replacement and displacement of toxic bile acids, other mechanisms of action include cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apotosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes, trenbolone 500.
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When used for the dissolution of cholesterol gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualised (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment. If the gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, ursodeoxycholic acid should not be used. When used for treatment of advanced stage of primary biliary cirrhosis: In very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Ursodeoxycholic acid should not be administered concomitantly with charcoal, colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after ursodeoxycholic acid. Ursodeoxycholic acid can increase the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary. In isolated cases ursodeoxycholic acid can reduce the absorption of ciprofloxacin. Ursodeoxycholic acid has been shown to reduce the plasma peak concentrations (C max ) and the area under the curve (AUC) of the calcium antagonist nitrendipine. An interaction with a reduction of the therapeutic effect of dapsone was also reported. These observations together with in vitro findings could indicate a potential for ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Controlled clinical trials have shown, however, that ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes. Oral contraceptives, oestrogenic hormones and blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter-effect to ursodeoxycholic acid used for dissolution of gallstones, trenbolone 500. There are no adequate data on the use of ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation. Ursodeoxycholic acid must not be used during pregnancy. Treatment should be discontinued immediately if pregnancy occurs and medical advice sought. Women of childbearing potential should be treated only if they are using reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking ursodeoxycholic acid for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis. The possibility of a pregnancy must be excluded before beginning treatment. It is not known whether ursodeoxycholic acid passes into breast milk. Therefore, ursodeoxycholic acid should not be taken during lactation. If treatment with ursodeoxycholic acid is necessary, breastfeeding must be discontinued. undefined Proyecto del tren transpeninsular descarriló más de 500 mdp. Desembolso de sct en proyecto cancelado. 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