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Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. Dosage Forms And Strengths. URSO 250: 250 mg tablet URSO Forte: 500 mg scored tablet. Each URSO 250 elliptical, biconvex, film-coated tablet, white, engraved with “URS785”, contains 250 mg of ursodiol. Available in bottles of 100 tablets ( NDC 58914-785-10). Each URSO Forte elliptical, biconvex, scored, film-coated tablet, white, engraved with “URS790”, contains 500 mg of ursodiol. Available in bottles of 100 tablets ( NDC 58914-790-10). Store at 20’C to 25’C (68’F to 77’F). Dispense in a tight container. Half-tablets (scored URSO Forte 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20’C to 25’C (68’F to 77’F). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see DOSAGE AND ADMINISTRATION ]. Manufactured in Canada for: Aptalis Pharma US, Inc. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials. ADVERSE REACTIONS VISIT AT 12 MONTHS VISIT AT 24 MONTHS UDCA n (%) Placebo n (%) UDCA n (%) Placebo n (%) Diarrhea — — 1 (1. UDCA = Ursodeoxycholic acid = Ursodiol. In a randomized, cross-over study in sixty PBC patients, seven patients (11. One patient on the twice a day regimen (total dose 1000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1000 mg or greater. However, an adverse reaction may occur at any dose. The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure, best steroid for muscle building.
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Adults and Elderly: The usual dose is 6 – 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary. The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s). Children: Dosage should be related to bodyweight. Children with cystic fibrosis aged 6 year to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with further increase to 30 mg/kg/day if necessary. Ursodeoxycholic acid should not be used in patients: 1. Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia. Ursodeoxycholic acid should be taken under medical supervision. During the first 3 months of treatment, the liver function parameters AST (SGOT), ALT (SGPT) and ?-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders and non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis. 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, best steroid for muscle building. 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. 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