URSODIOL capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

PuraCap Laboratories, LLC

INN (Jina la Kimataifa):

URSODIOL

Tungo:

URSODIOL 300 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

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. 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

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

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
CONS IDERED.
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 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