URSODIOL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)

Tillgänglig från:

Glenmark Pharmaceuticals Inc., USA

INN (International namn):

URSODIOL

Sammansättning:

URSODIOL 250 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. Risk Summary Available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to ursodiol occurred in the second and third trimester of pregnancy. In animal reproduction studies, ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or ot

Produktsammanfattning:

Each Ursodiol Tablet, USP 250 mg is a white to off-white, oval shaped, film-coated tablet debossed with “G72” on one side and “250” on the other side and contains 250 mg ursodiol, USP. Ursodiol Tablets, USP 250 mg are available in: Bottles of 30 tablets, NDC 68462-473-30 Bottles of 100 tablets, NDC 68462-473-01 Bottles of 500 tablets, NDC 68462-473-05 Each Ursodiol Tablet, USP 500 mg is a white to off-white, oval shaped, film-coated tablet debossed with “U 11” on one side and a score line on the other side and contains 500 mg ursodiol, USP. Ursodiol Tablets, USP 500 mg are available in: Bottles of 30 tablets, NDC 68462-474-30 Bottles of 100 tablets, NDC 68462-474-01 Bottles of 500 tablets, NDC 68462-474-05 Store at 20℃ to 25℃ (68℉ to 77℉) [see USP Controlled Room Temperature]. Dispense in a tight container. Half-tablets (scored Ursodiol Tablets, USP 500 mg broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20℃ to 25℃ (68℉ to 77℉). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.3)].

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

URSODIOL- URSODIOL TABLET
GLENMARK PHARMACEUTICALS INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
URSODIOL TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR URSODIOL
TABLETS.
URSODIOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Ursodiol tablets, 250 mg and 500 mg are bile acids indicated for the
treatment of patients with primary
biliary cholangitis. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
Patients with complete biliary obstruction and known hypersensitivity
or intolerance to ursodiol or any of
the components of the formulation. (4)
WARNINGS AND PRECAUTIONS
•
•
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 GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
•
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2023
Warnings and Precautions (5.2) 01/2023
Recommended adult dosage: 13 to 15 mg/kg/day administered in two to
four divided doses with food.
(2.1)
Scored ursodiol tablet, 500 mg: scored tablet can be broken in halves
to provide recommended
dosage. (2.3, 16)
Ursodiol Tablets, USP 250 mg: 250 mg tablet (3)
Ursodiol Tablets, USP 500 mg: 500 mg scored tablet (3)
Abnormal Liver Function Tests: Liver function tests (γ-GT, alkaline
phosphatase, AST, ALT) and
bilirubin level should be monitored. Treatment discontinuation should
be considered if parameters
increase to a level considered clinically significant in patients with
stable historical liver function test
levels. Caution should be exercised to maintain patients’ bile flow.
(5.1)
Enteroliths in Patients with Risk fo