Drug Catalog - Product Detail
URSODIOL USP TB 250MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00115-1524-01 | AMNEAL PHARMACEUTICALS | 100 | 250MG | TABLET |
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Description
11 DESCRIPTION Ursodiol, 250 mg is available as a film-coated tablet for oral administration. 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,7β-dihydroxy-5β-cholan-24-oic (C 24 H 40 O 4 ). Ursodiol has a molecular weight of 392.56. Its structure is shown below. Inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, povidone, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide, and macrogol/polyethylene glycol. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Ursodiol Tablets USP, 250 mg Each 250 mg tablet - white, film coated, oval shaped beveled edged, biconvex tablet debossed with " 2368 " on one side, contains 250 mg of ursodiol. Available in bottles of 100 tablets (NDC 0115-1524-01). 16.2 Ursodiol Tablets USP, 500 mg Each 500 mg tablet - white, film coated, oval shaped beveled edged, biconvex tablet debossed with " 2369 " on one side and scored on the other side, contains 500 mg of ursodiol. Available in bottles of 100 tablets (NDC 0115-1525-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Half-tablets (scored ursodiol 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20° to 25°C (68° to 77°F). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [ see Dosage and Administration (2.2) ].
Indications & Usage
1 INDICATIONS AND USAGE Ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Ursodiol tablets are bile acids indicated for the treatment of patients with primary biliary cirrhosis ( 1 )
Dosage and 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 ursodiol 500 mg tablet: scored tablet can be broken in halves to provide recommended dosage ( 2.2 , 16.2 ) 2.1 General Dosing Information The recommended adult dosage for ursodiol 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 Ursodiol Tablet USP, 500 mg The ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage. To break ursodiol 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) ].