Test 250 side effects

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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 < ) difference between the two treatments (n=106 for the URSO 250 group and n=106 for the placebo group), in favor of ursodiol, was demonstrated in the following: reduction in the proportion of patients exhibiting a more than 50% increase in serum bilirubin; median percent decrease in bilirubin (-% for the URSO 250 group vs. +% for the placebo group), transaminases (-% for the URSO 250 group vs. +% for the placebo group) and alkaline phosphatase (-% for the URSO 250 group vs. -% for the placebo group); incidence of treatment failure; and time to treatment failure. The definition of treatment failure included: discontinuing the study for any reason; a total serum bilirubin level greater than or equal to mg/dl or increasing to a level equal to or greater than two times the baseline level; and the development of ascites or encephalopathy. Evaluation of patients at 4 years or longer was inadequate due to the high drop out rate (n=10 withdrew from the URSO 250 group vs. n=15 from the placebo group) and small number of patients. Therefore, death, need for liver transplantation, histological 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 were not assessed.

Allergic-type reactions such as skin rash, urticaria , pruritus , angioedema , and respiratory symptoms have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of dyspnea , palpitations , hypotension, atrial fibrillation , arrhythmia , tachycardia , skin desquamation including reports of Stevens-Johnson syndrome , erythema multiforme , dermatitis exfoliative, constipation, vomiting, dry mouth , visual impairment, and epistaxis have been received during the postmarketing period.

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 , times the maximum recommended human dose based on body surface area) suppressed the colonic carcinogenic effect of another known carcinogen azoxymethane.

Test 250 side effects

test 250 side effects

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 , times the maximum recommended human dose based on body surface area) suppressed the colonic carcinogenic effect of another known carcinogen azoxymethane.

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