Drug Catalog - Product Detail
URSODIOL USP 500MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0413-01 | PAR PHARMACEUTICAL | 100 | 500MG | TABLET |
PACKAGE FILES
Generic Name
URSODIOL
Substance Name
URSODIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202540
Description
11 DESCRIPTION Ursodiol Tablets, USP 250 mg are available as a film-coated tablet for oral administration. Ursodiol Tablets, USP 500 mg are 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 (C 24 H 40 O 4 ). Ursodiol has a molecular weight of 392.56. Its structure is shown below. Inactive ingredients: caprylic/capric triglycerides, copovidone, hypromellose, microcrystalline cellulose, magnesium stearate, povidone, polydextrose, polyethylene glycol 3350, sodium starch glycolate type A and titanium dioxide. ursodiol-structure.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Ursodiol Tablet, USP 250 mg The 250 mg dosage form is a white to off-white, modified capsule shaped, film-coated tablet, imprinted with “P” and “412” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 49884-412-01) with a child resistant closure. 16.2 Ursodiol Tablet, USP 500 mg The 500 mg dosage form is a white to off-white, modified capsule shaped, film-coated tablet, imprinted with “P” and “413” on one side and bisected on the other side. Tablets are supplied in bottles of 100 (NDC 49884-413-01) with a child resistant closure. 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 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.2)] . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Ursodiol tablets, USP 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 to 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 to 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 ( y- GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for the three months after start of therapy, and every six months thereafter [see Warnings and Precautions ( 5.1 ) ]. 2.3 Scoring the Ursodiol 500 mg Tablet The ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage. To break ursodiol 500 mg 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) ] .