URSODIOL capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

PuraCap Laboratories, LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 (C24 H40 O4 ). 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.

Produktu pārskats:

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. They are supplied: NDC 24658-780-01 Bottles of 100 Capsules. NDC 24658-999-10 Bottles of 1000 Capsules. 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. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Franklin, KY 42134 USA 1-877-264-0258 Manufactured in USA Issued September 2016 MF503ISS09/16 OE2631

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

URSODIOL- URSODIOL CAPSULE
PURACAP LABORATORIES, LLC
----------
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
CONSIDERED.
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
24
40
4
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