URSODIOL tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Actavis Pharma, Inc.

INN (Nama Internasional):

URSODIOL

Komposisi:

URSODIOL 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

      Ursodiol tablets, USP 250 mg and 500 mg 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.       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 tablets, US

Ringkasan produk:

      Each ursodiol tablets, USP 250 mg elliptical, biconvex, film-coated tablet, white, engraved with "URS785", contains 250 mg of ursodiol. Available in bottles of 100 tablets (NDC 0591-2998-01).       Each ursodiol tablets, USP 500 mg elliptical, biconvex, scored, film-coated tablet, white, engraved with "URS790", contains 500 mg of ursodiol. Available in bottles of 100 tablets (NDC 0591-3005-01).       Store at 20°C to 25°C (68°F to 77°F). 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 20ºC to 25ºC (68ºF to 77ºF). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.3) ].

Status otorisasi:

New Drug Application Authorized Generic

Karakteristik produk

URSODIOL- URSODIOL TABLET
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
URSODIOL TABLETS, 250
MG AND 500 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR URSODIOL
TABLETS, 250 MG AND 500 MG TABLETS.
URSODIOL TABLETS, 250 MG, FOR ORAL USE
URSODIOL TABLETS, 500 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Ursodiol tablets, USP 250 mg and 500 mg are bile acids indicated for
the treatment of patients with
primary biliary cirrhosis (1)
DOSAGE AND ADMINISTRATION
Recommended adult dosage: 13-15 mg/kg/day administered in two to four
divided doses with food (2.1)
Scored ursodiol tablets, USP 500 mg: scored tablet can be broken in
halves to provide recommended
dosage (2.3, 16.2)
DOSAGE FORMS AND STRENGTHS
Ursodiol tablets, USP 250 mg: 250 mg tablet (3)
Ursodiol tablets, USP 500 mg: 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 (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 (5).
Caution should be exercised to maintain patients’ 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 ACTAVIS AT
1-800-272-5525 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Bile Acid Se