URSODIOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

URSODIOL

Composition:

URSODIOL 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Ursodiol capsules, USP are 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 capsules beyond 24 months is not established. - Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - Ursodiol capsules 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 are available containing 300 mg of ursodiol, USP. The 300 mg capsules are hard-shell gelatin capsules with a peach opaque cap and a white opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 1730 in black ink on both the cap and body. They are available as follows: NDC 51079-383-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12267 12/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

URSODIOL- URSODIOL CAPSULE
MYLAN INSTITUTIONAL INC.
----------
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 considered.
DESCRIPTION
Ursodiol Capsules, USP are 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 white
crystalline powder freely soluble in alcohol and in glacial acetic
acid, slightly soluble in
acetone, methylene chloride, and ether, sparingly soluble in
chloroform, and practically
insoluble in water. The chemical name for ursodiol is
3α,7β-Dihydroxy-5β-cholan-24-oic
acid (C
H
O
). Ursodiol has a molecular weight of 392.57. Its structure is shown
below:
Each capsule contains 300 mg of ursodiol, USP with the following
inactive ingredients:
colloidal silicon dioxide, corn starch, FD&C Yellow No. 6, gelatin,
hydroxypropyl cellulose,
magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate,
sodium starch
glycolate and titanium dioxide.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum
Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake,
FD&C Red No.
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
24
40
4
is conjugated with either g