URSODIOL 200 MG- usodiol capsule URSODIOL 400 MG- usodiol capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

LGM Pharma Solutions, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ursodiol is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. Ursodiol (ursodesoxycholic 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 (C24 H40 O4 ). Ursodiol has a molecular weight of 392.57. Its structure is shown below: Inactive Ingredients: Silicon dioxide, magnesium stearate, and corn starch. Gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains FD&C Yellow #6 and D&C Yellow #10.

Product summary:

Ursodiol Capsules, USP 200 mg are opaque white capsules imprinted with a thick black bar. Ursodiol Capsules, USP 400 mg are opaque yellow and white capsules imprinted with a thick black bar. Bottles of 100 are supplied with child-resistant closures. Ursodiol Capsules, USP 200 mg (NDC 79739-7143-1) Ursodiol Capsules, USP 400 mg (NDC 79739-7144-1) Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Dispense in tight container (USP). Rx only Keep out of reach of children. Manufactured By: Nexgen Pharma, Inc. Irvine, CA 92614 Revised: 08/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

URSODIOL 200 MG- USODIOL CAPSULE
URSODIOL 400 MG- USODIOL CAPSULE
LGM PHARMA SOLUTIONS, LLC
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URSODIOL CAPSULES, USP
RX ONLY
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 200 mg and 400 mg capsules
suitable for oral administration.
Ursodiol (ursodesoxycholic 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 has a molecular weight of 392.57. Its structure is
shown below:
_Inactive Ingredients: _Silicon dioxide, magnesium stearate, and corn
starch. Gelatin capsules contain
gelatin and titanium dioxide and are printed with edible black ink;
additionally, the 400 mg capsule also
contains FD&C Yellow #6 and D&C Yellow #10.
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 systemi