Urso 250
Loading...Urso 250 Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
URSO 250® and URSO Forte® (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
History
There is currently no drug history available for this drug.
Other Information
URSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 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 powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic (C24H40O4). Ursodiol has a molecular weight of 392.56. Its structure is shown below.
Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, ethylcellulose, dibutyl sebacate, carnauba wax, hydroxypropyl methylcellulose, PEG 3350, PEG 8000, cetyl alcohol, sodium lauryl sulfate and hydrogen peroxide.
Sources
Urso 250 Manufacturers
-
Aptalis Pharma Us, Inc.
![Urso 250 (Ursodiol) Tablet, Film Coated Urso Forte (Ursodiol) Tablet, Film Coated [Aptalis Pharma Us, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Urso 250 | Aptalis Pharma Us, Inc.
2.1 General Dosing InformationThe 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.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the URSO Forte TabletThe URSO Forte scored tablet can be broken in halves to provide recommended dosage.
To break URSO Forte scored tablet easily, place the tablet on a flat surface with the scored section on top. 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. [see How Supplied/Storage and Handling (16.2)].
Login To Your Free Account