URSODIOL tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

BluePoint Laboratories

DCI (Dénomination commune internationale):

URSODIOL

Composition:

URSODIOL 250 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Patients with complete biliary obstruction and known 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 moth

Descriptif du produit:

Each 250 mg tablet - white, film coated, oval shaped beveled edged, biconvex tablet debossed with "IX524" on one side, contains 250 mg of ursodiol.  Available in bottles of 100 tablets (NDC 68001-343-00). Each 500 mg tablet - white, film coated, oval shaped beveled edged, biconvex tablet debossed with "IX525" on one side and scored on the other side, contains 500 mg of ursodiol.  Available in bottles of 100 tablets (NDC 68001-344-00). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight container. 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). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.2)] .

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

URSODIOL- URSODIOL TABLET, FILM COATED
BLUEPOINT LABORATORIES
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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
•
•
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 IMPAX LABORATORIES, INC.
AT 1-800-934-6729 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Liver Function Tests
2.3 Scoring the Ursodiol Tablet USP, 500 mg
3 DOSAGE FORMS AND STRENGTHS
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)
Ursodiol: 250 mg tablet (3)
Ursodiol: 500 mg scored tablet (3)
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
consid