País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)
Physicians Total Care, Inc.
URSODIOL
URSODIOL 300 mg
ORAL
PRESCRIPTION DRUG
- Ursodiol 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 ursodiol beyond 24 months is not established. Ursodiol 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 ursodiol beyond 24 months is not established. - Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. Ursodiol is indicated for the prevention of gallstone formation in obese patients expe
Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted WATSON on one half and 3159 on the other half of the capsule in black. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Dispense in a tight container (USP). Rx only Keep out of reach of children. Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: March 2009 174784 S0309 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
New Drug Application Authorized Generic
URSODIOL - URSODIOL CAPSULE PHYSICIANS TOTAL CARE, INC. ---------- URSODIOL CAPSULES USP REVISED: MARCH 2009 RX ONLY 174784 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: _Colloidal silicon dioxide, magnesium stearate, and starch (corn). Gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing black iron oxide. 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 the cystic and common ducts by gallbladder contractions provoked by physiologic responses to eating. Only small quantities of ursodiol appear in the systemic circulation and very small Leia o documento completo