URSODIOL- ursosiol capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

URSADIOL (UNII: 3D089V7L0K) (URSADIOL - UNII:3D089V7L0K)

Доступна з:

PD-Rx Pharmaceuticals, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

- Ursodiol Capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol capsules beyond 24 months is not established. - Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - Ursodiol capsules will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol capsules therapy. - Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol capsules therapy. - Allergy to bile aci

Огляд продуктів:

Ursodiol Capsules, USP are pink opaque cap, white opaque body with black imprint “K237” on both cap and body containing white to off-white powder. NDC 43063-871-01 Bottles of 100 NDC 43063-871-60 Bottles of 60 NDC 43063-871-93 Bottles of 180 Store at 20 to 25°C (68 to 77°F); excursions permitted within 15 o to 30 o C (59 o to 86 o F). [see USP Controlled Room Temperature]. Dispense in tight container (USP). Keep out of reach of children. For all medical inquiries contact: KVK-Tech, Inc. Customer Service 1-215-579-1842

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

URSODIOL- URSOSIOL CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
URSODIOL CAPSULES, USP
RX ONLY
PRESCRIBING INFORMATION
SPECIAL NOTE
GALLBLADDER STONE DISSOLUTION WITH URSODIOL CAPSULES, USP 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 is a bile acid available as 300 mg capsules
suitable for oral
administration.
Ursodiol, USP is ursodeoxycholic acid, 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: _Colloidal silicon dioxide, corn starch and
magnesium stearate.
Gelatin capsules contain red iron oxide, gelatin, and titanium
dioxide. The capsules are
printed with edible ink containing shellac, black iron oxide,
propylene glycol, FD&C Blue #
2 aluminum lake, FD&C Red # 40 aluminum lake, D&C Yellow # 10 aluminum
lake and
FD&C Blue # 1 aluminum lake.
24
40
4
CLINICAL PHARMACOLOGY
About 90% of a therapeutic dose of ursodiol capsules 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