URSODIOL tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Par Pharmaceutical, Inc.

INN (International namn):

URSODIOL

Sammansättning:

URSODIOL 250 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. There are no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mothe

Produktsammanfattning:

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. 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

URSODIOL- URSODIOL TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
----------
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
INDICATIONS AND USAGE
Ursodiol tablets, USP are bile acids indicated for the treatment of
patients with primary biliary cirrhosis (1)
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)
DOSAGE FORMS AND STRENGTHS
Ursodiol 250 mg tablet (3)
Ursodiol 500 mg scored tablet (3)
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
Patients with variceal bleeding, hepatic encephalopathy, ascites or in
need of an urgent liver transplant, should receive
appropriate specific treatment (5).
Liver function tests (_y_-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 (5).
Caution should be exercised to maintain patient's bile flow (5).
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 PAR PHARMACEUTICAL AT
1-800-828-9393 OR FDA AT 1-
800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
Bile Acid Sequestering Agents: May interfere with the action of
ursodiol by reducing its absorption (7.1)
Aluminum-based Antacids: May interf