URSODIOL 200 MG- ursodiol capsule URSODIOL 400 MG- ursodiol capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

FH2 Pharma LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Ursodiol Capsules, USP 200 mg are supplied as opaque white body and opaque white cap, imprinted with "ISL" on one half and "U-200" on the other half of the capsule. Ursodiol Capsules, USP 400 mg are opaque yellow and white capsules imprinted with with "ISL" on one half and "U-400" on the other half of the capsule. Bottles of 60 are supplied with child-resistant closures. Ursodiol Capsules, USP 200 mg (NDC 72887-143-06) Ursodiol Capsules, USP 400 mg (NDC 72887-144-06) 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. Distributed by: FH2 Pharma LLC Delray Beach, FL 33444 7143-AG Revised: 06/2021

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

URSODIOL 200 MG- URSODIOL CAPSULE
URSODIOL 400 MG- URSODIOL CAPSULE
FH2 PHARMA 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
CONSIDERED.
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
24
40
4
by physiologic responses to eating. Only small quantities of ursodiol
appear in the
systemic