ACTIGALL- ursodiol capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Actavis Pharma, Inc.

ІПН (Міжнародна Ім'я):

URSODIOL

Склад:

URSODIOL 300 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

- Actigall is 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 Actigall beyond 24 months is not established. - Actigall is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - Actigall will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment  stones. Hence, patients with such stones are not candidates for Actigall therapy. - Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for Actigall therapy. - Allergy to bile acids.

Огляд продуктів:

Actigall Capsules are opaque white and pink capsules imprinted “ACTIGALL” on one half and “300 mg” on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures. (NDC 52544-930-01) Store at 20-25°C (68-77°F). [See USP controlled room temperature.]  Dispense in a tight container (USP). Keep out of reach of children. Rx only For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Content Updated: November 2014 174785-1

Статус Авторизація:

New Drug Application

Характеристики продукта

ACTIGALL- URSODIOL CAPSULE
ACTAVIS PHARMA, INC.
----------
ACTIGALL
(URSODIOL, USP) CAPSULES
CONTENT UPDATED: NOVEMBER 2014
RX ONLY
174785-1
PRESCRIBING INFORMATION
SPECIAL NOTE
GALLBLADDER STONE DISSOLUTION WITH ACTIGALL 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
Actigall is a bile acid available as 300 mg capsules suitable for oral
administration.
Actigall is ursodiol, USP (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, magnesium stearate,
and starch (corn). Gelatin capsules
contain ferric oxide, gelatin, and titanium dioxide. The capsules are
printed with edible ink containing
black iron oxide.
CLINICAL PHARMACOLOGY
About 90% of a therapeutic dose of Actigall 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