Country: United States
Language: English
Source: NLM (National Library of Medicine)
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)
AvPAK
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 the prevention of gallstone formation in obese patients experiencing rapid weight loss. - Ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol 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 therapy. - Allergy to bile acids.
Ursodiol Capsules USP, 300 mg are opaque white and pink capsules, filled with white powder. They are imprinted “Є503” in black ink on cap and body and are supplied in blister packs of 50 count NDC 50268-796-15. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispensed in a blister punch material for Institutional Use Only. Keep out of reach of children. Manufactured For: AvPAK A Division of AvKARE, Inc. Pulaski, TN 38478 Mfg. Iss. 05/10 AV 07/12
Abbreviated New Drug Application
URSODIOL- URSODIOL CAPSULE AVPAK ---------- URSODIOL CAPSULES, USP 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 the cystic and common ducts Read the complete document