URSODIOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

URSODIOL

Composition:

URSODIOL 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 or almost 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 (C24 H40 O4 ). 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

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 0378-1730-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 5/2020 USDL:R4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

URSODIOL- URSODIOL CAPSULE
MYLAN PHARMACEUTICALS 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 or almost 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 ducts. Ursodiol i