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Carcinogenesis, Mutagenesis, Impairment of Fertility. In two 24-month oral carcinogenicity studies in mice, Ursodiol at doses up to 1,000 mg/kg/day (3,000 mg/m 2 /day) was not tumorigenic. Based on body surface area, for a 50 kg person of average height (1. In a two-year oral carcinogenicity study in Fischer 344 rats, Ursodiol at doses up to 300 mg/kg/day (1,800 mg/m 2 /day, 3. In a life-span (126-138 weeks) oral carcinogenicity study, Sprague-Dawley rats were treated with doses of 33 to 300 mg/kg/day, 0. Ursodiol produced a significantly (p?0. In 103-week oral carcinogenicity studies of lithocholic acid, a metabolite of Ursodiol, doses up to 250 mg/kg/day in mice and 500 mg/kg/day in rats did not produce any tumors. In a 78-week rat study, intrarectal instillation of lithocholic acid (1 mg/kg/day) for 13 months did not produce colorectal tumors. A tumor-promoting effect was observed when it was administered after a single intrarectal dose of a known carcinogen N-methyl-N’-nitro-N-nitrosoguanidine. On the other hand, in a 32-week rat study, Ursodiol at a daily dose of 240 mg/kg (1,440 mg/m 2 , 2. Ursodiol was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y, TK+/-) forward mutation test, the human lymphocyte sister chromatid exchange test, the mouse spermatogonia chromosome aberration test, the Chinese hamster micronucleus test and the Chinese hamster bone marrow cell chromosome aberration test. Ursodiol at oral doses of up to 2,700 mg/kg/day (16,200 mg/m 2 /day, 29 times the recommended maximum human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats. Efficacy of Ursodeoxycholic Acid Administered at 13 to 15 mg/kg/day in 3 or 4 Divided Doses to PBC Patients. Upon completion of the double-blind portion, all patients entered an open-label active treatment extension phase. Treatment failure, the main efficacy endpoint measured during this study, was defined as death, need for liver transplantation, histologic progression by two stages or to cirrhosis, development of varices, ascites or encephalopathy, marked worsening of fatigue or pruritus, inability to tolerate the drug, doubling of serum bilirubin and voluntary withdrawal. After two years of double-blind treatment, the incidence of treatment failure was significantly (p 1, buy susta 350 mg injectable steroids sustanon (testosterone blend). Using a definition of treatment failure, which excluded doubling of serum bilirubin and voluntary withdrawal, time to treatment failure was significantly delayed in the Ursodiol tablets, 250 mg group. In comparison with placebo, treatment with Ursodiol tablets, 250 mg resulted in a significant improvement in the following serum hepatic biochemistries when compared to baseline: total bilirubin, SGOT, alkaline phosphatase and IgM. Efficacy of Ursodiol Administered at 14 mg/kg/day as a Once Daily Dose to PBC Patients. A second study conducted in Canada randomized 222 PBC patients to Ursodiol, 14 mg/kg/day or placebo, administered as a once daily dose in a double-blind manner during a two-year period. At two years, a statistically significant (p [ see Dosage and Administration (2. Patients with the following conditions should be instructed to receive appropriate management measures: variceal bleeding, hepatic encephalopathy, ascites, in need of an urgent liver transplant or hepatic function deterioration. Caution has to be exercised to maintain the bile flow of the patients taking Ursodiol. Patients should be informed that absorption of Ursodiol tablets, USP 250 mg and 500 mg may be reduced if they are taking bile acid sequestering agents, such as cholestyramine and colestipol, aluminum-based antacids, or drugs known to alter the metabolism of cholesterol [see Drug Interactions (7)]. Ursodiol For Dogs: Uses, Dosage, & Side Effects.
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. Description Clinical Pharmacology Indications and Usage Contraindications Precautions Drug Interactions Adverse Reactions/Side Effects Overdosage Dosage and Administration How Supplied/Storage and Handling. If this becomes troublesome, speak with your doctor Other possible but less common side-effects What can I do if I experience this? Itchy skin rash, feeling sick (nausea) If either of these becomes troublesome, speak with your doctor, steroid emergency card guidance
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