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The approval rested primarily on the results of two Phase III trials conducted in approximately 300 patients. A two-year 180-patient study performed by the Mayo Clinic dosed patients at 13-15 mg/kg per day with Urso tablets 250 mg four times daily. The recommended adult dosage for Urso 250 and Urso Forte in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician. The Urso Forte scored tablet can be broken in halves to provide recommended dosage.
Urso IndicationsPatients who are taking this medicine in order to treat gallstones might have to continue their treatment with this drug for several months. Even after such a long term treatment with Urso, some gallstones might not entirely dissolve. Most patients who have followed a prolonged treatment with this medicine will probably develop the same condition (gallstones) a few years after they stop their treatment with it. Your physician knows more about the risk that repeated gallstones involve. In order to check to see if your treatment with this medicine is paying off the proper benefitic effects, you will probably have to undergo a series of medical tests during your treatment with this drug. How Should I Use This Medicine?You might also have to perform kidney tests as well. You should not miss any of you appointments with your personal physician that are related with your intake of Urso. Patients who are suffering from known allergic reactions to any of this drug's components will probably not be allowed to start taking Urso. Before you start using this product you should inform your personal health care specialist if you are allergic to any dyes, foods, preservatives or any other type of substances (this includes other medicines). Urso Intake GuidelinesBefore you take your first dose of Urso you should ask your personal health care provider to give you a set of precise directions regarding how and when you should take this medicine. You should not disobey from any of your personal doctor's directions. If you have any further questions regarding your intake of this medicine you should refer to a nurse or to a pharmacist and ask them for additional explanations. Read the medicine's label for further information about this medicine. Each dose of this medicine should be accompanied by a full glass of liquid (juice or water). You should ask your personal health care specialist to give you the exact dose of this medicine that you should take in on a regular basis. What If I Miss A Dose?Also tell them if you smoke, drink alcohol, or use illegal drugs. Teratology studies have been performed in pregnant rats at oral doses up to 2,000 mg/kg/day (12,000 mg/m/day, 22 times the recommended maximum human dose based on body surface area) and in pregnant rabbits at oral doses up to 300 mg/kg/day (3,600 mg/m/day, 7 times the recommended maximum human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. What May Interact With This Medicine?Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. In a two-year oral carcinogenicity study in Fischer 344 rats, ursodiol at doses up to 300 mg/kg/day (1,800 mg/m/day, 3.2 times the recommended maximum human dose based on body surface area) was not tumorigenic. In a life-span (126-138 weeks) oral carcinogenicity study, Sprague-Dawley rats were treated with doses of 33 to 300 mg/kg/day, 0.4 to 3.2 times the recommended maximum human dose based on body surface area. |
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