Urso 250 250 mg/1
Ursodiol · TABLET, FILM COATED · Allergan, Inc.
Urso 250 is a tablet, film coated containing ursodiol at 250 mg/1, taken oral. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- Urso 250
- Generic Name
- Ursodiol
- NDC Code (Product)
58914-785- Manufacturer
- Allergan, Inc.
- Strength
- 250 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA020675
- Drug Class
- Bile Acid [EPC]
- Marketing Start
- 12/10/1997
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended adult dosage : 13-15 mg/kg/day administered in two to four divided doses with food. ( 2.1 ) Scored URSO Forte tablet : scored tablet can be broken in halves to provide recommended dosage. ( 2.3 , 16 ) 2.1 General Dosing Information 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. 2.2 Liver Function Tests Liver 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 Tablet The 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 …
Contraindications
4 CONTRAINDICATIONS Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Bile Acid Sequestering Agents : May interfere with the action of URSO 250 and URSO Forte by reducing its absorption. ( 7.1 ) Aluminum-based Antacids : May interfere with the action of URSO 250 and URSO Forte by reducing its absorption. ( 7.2 ) Drugs that alter the metabolism of lipids or induce cholestasis may interfere with the action of URSO 250 and URSO Forte. ( 7.3 ) 7.1 Bile Acid Sequestering Agents Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250 and URSO Forte by reducing its absorption. 7.2 Aluminum-based Antacids Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with URSO 250 and URSO Forte in the same manner as the bile acid sequestering agents. 7.3 Drugs Affecting Lipid Metabolism Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of URSO 250 and URSO Forte.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions reported with the use of ursodiol during worldwide postmarketing and clinical experience (≥1%) are, in alphabetical order: abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience 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 (1.32) --- Elevated creatinine --- --- 1 (1.32) --- Elevated blood glucose 1 (1.18) --- 1 (1.32) --- Leukopenia --- --- 2 (2.63) --- Peptic ulcer --- --- 1 (1.32) --- Skin rash --- --- 2 (2.63) --- Thrombocytopenia --- --- 1 (1.32) --- Note: Those adverse reactions occurring …
Frequently Asked Questions
What is Urso 250 used for?
Urso 250 contains Ursodiol. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Urso 250 a controlled substance?
Urso 250 is not classified as a controlled substance by the DEA.
What is the generic name for Urso 250?
The generic name for Urso 250 is Ursodiol. There are 12 other brand versions of Ursodiol.
What is the NDC code for Urso 250 250 mg/1?
The NDC (National Drug Code) for Urso 250 250 mg/1 is 58914-785, listed by Allergan, Inc..