URSODIOL- ursodiol tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

American Health Packaging

INN (International Nazwa):

URSODIOL

Skład:

URSODIOL 250 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Ursodiol tablets 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 mother. Th

Podsumowanie produktu:

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 unit dose packages of 30 (5 x 6) NDC 68084-892-25. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

URSODIOL- URSODIOL TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
URSODIOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR URSODIOL.
URSODIOL TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Ursodiol tablets 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 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 (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 WATSON LABORATORIES,
INC. AT 1-800-272-5525 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 inte