URSODIOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

URSODIOL

Composition:

URSODIOL 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. - Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. Ursodiol is indicated for the prevention of gallstone formation in obese patients expe

Product summary:

Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted WATSON on one half and 3159 on the other half of the capsule in black. Blisterpacks of 30. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Dispense in a tight container (USP). Rx only Keep out of reach of children. Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: August 2008 2000700-00 S0808

Authorization status:

New Drug Application

Summary of Product characteristics

URSODIOL- URSODIOL CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
URSODIOL CAPSULES USP
REVISED: AUGUST 2008
RX ONLY
2000700-00
PRESCRIBING INFORMATION
SPECIAL NOTE
GALLBLADDER STONE DISSOLUTION WITH URSODIOL TREATMENT REQUIRES MONTHS
OF THERAPY. COMPLETE
DISSOLUTION DOES NOT OCCUR IN ALL PATIENTS AND RECURRENCE OF STONES
WITHIN 5 YEARS HAS BEEN
OBSERVED IN UP TO 50% OF PATIENTS WHO DO DISSOLVE THEIR STONES ON BILE
ACID THERAPY. PATIENTS
SHOULD BE CAREFULLY SELECTED FOR THERAPY WITH URSODIOL, AND
ALTERNATIVE THERAPIES SHOULD BE
CONS IDERED.
DESCRIPTION
Ursodiol is a bile acid available as 300 mg capsules suitable for oral
administration.
Ursodiol USP (ursodeoxycholic acid) is a naturally occurring bile acid
found in small quantities in
normal human bile and in the biles of certain other mammals. It is a
bitter-tasting, white powder freely
soluble in ethanol, methanol, and glacial acetic acid; sparingly
soluble in chloroform; slightly soluble in
ether; and insoluble in water. The chemical name for ursodiol is
3α,7β-Dihydroxy-5β-cholan-24-oic
acid (C
H O ). Ursodiol, USP has a molecular weight of 392.57. Its structure
is shown below:
_Inactive Ingredients: _Colloidal silicon dioxide, magnesium stearate,
and starch (corn). Gelatin capsules
contain gelatin and titanium dioxide. The capsules are printed with
edible ink containing black iron
oxide.
CLINICAL PHARMACOLOGY
About 90% of a therapeutic dose of ursodiol is absorbed in the small
bowel after oral administration.
After absorption, ursodiol enters the portal vein and undergoes
efficient extraction from portal blood by
the liver (i.e., there is a large “first-pass” effect) where it is
conjugated with either glycine or taurine
and is then secreted into the hepatic bile ducts. Ursodiol in bile is
concentrated in the gallbladder and
expelled into the duodenum in gallbladder bile via the cystic and
common ducts by gallbladder
contractions provoked by physiologic responses to eating. Only small
quantities of ursodiol appear in
the systemic circula