URSODIOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

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 the prevention of gallstone formation in obese patients experiencing rapid weight loss. - Ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol therapy. - Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. - Allergy to bile acids.

Product summary:

Ursodiol Capsules USP, 300 mg are #0 capsules with a pink opaque cap, white opaque body, imprinted “Є503” in black ink on cap and body, filled with white powder. It is supplied in bottles of 100 NDC 60429-138-01. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012 Rev. 11-2018-01 MF503REV11/18 OE1105

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

URSODIOL- URSODIOL CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
URSODIOL CAPSULES USP, 300 MG
RX ONLY
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: _Corn starch, magnesium stearate, silicon
dioxide and the capsule shell contain the
following ingredients, gelatin, titanium dioxide, D&C Red # 28, FD&C
Blue # 1 and FD&C Red # 40.
The imprinting ink contains the following: black iron oxide, D&C
Yellow # 10 Aluminum Lake, FD&C
Blue # 1 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40
Aluminum Lake, propylene
glycol and shellac glaze.
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