URSODIOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. Ursodiol, USP is a white or almost white crystalline powder, practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone and practically insoluble in methylene chloride. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24 H40 O4 ). Ursodiol, USP has a molecular weight of 392.6 g/mol. Its structure is shown below: Inactive Ingredients : Colloidal silicon dioxide, gelatin, iron oxide red, magnesium stearate, starch (biological source: maize), titanium dioxide and water. Each capsule is imprinted with black pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, purified water, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

Product summary:

Ursodiol Capsules USP, 300 mg are supplied as opaque white body and pink cap, imprinted “AN” on one half and “1540” on the other half of the capsules in black. They are available as follows: Cartons of 50 capsules (10 capsules per blister pack x 5), NDC 0904-7168-06 Cartons of 100 capsules (10 capsules per blister pack x 10), NDC 0904-7168-61 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in USP. Keep this and all medications out of reach of children.   Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Rev. 11-2018-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

URSODIOL- URSODIOL CAPSULE
MAJOR PHARMACEUTICALS
----------
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 (ursodeoxycholic acid), is a naturally occurring bile acid
found in small quantities
in normal human bile and in the biles of certain other mammals.
Ursodiol, USP is a white
or almost white crystalline powder, practically insoluble in water,
freely soluble in ethanol
(96%), slightly soluble in acetone and practically insoluble in
methylene chloride.
The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic
acid (C
H
O ).
Ursodiol, USP has a molecular weight of 392.6 g/mol. Its structure is
shown below:
_INACTIVE INGREDIENTS_: Colloidal silicon dioxide, gelatin, iron oxide
red, magnesium
stearate, starch (biological source: maize), titanium dioxide and
water.
24
40
4
Each capsule is imprinted with black pharmaceutical ink which contains
butyl alcohol,
dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, purified
water, potassium
hydroxide, propylene glycol, shellac and strong ammonia solution.
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 vi