Drug Catalog - Product Detail
URSODIOL, USP CP 300MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00527-1326-01 | LANNETT | 100 | 300MG | CAPSULE |
PACKAGE FILES
Generic Name
URSODIOL
Substance Name
URSODIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA079082
Description
DESCRIPTION Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol 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,7 β -dihydroxy-5 β -cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol, USP has a molecular weight of 392.58. Its structure is shown below: Inactive Ingredients: Pregelatinized Starch, Colloidal Silicon Dioxide, Magnesium Stearate. The capsule shell consists of FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Titanium Dioxide, and Gelatin. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol, and Methanol. Chemical Structure
How Supplied
HOW SUPPLIED 300 mg: Size #0 pink opaque cap and a white opaque body imprinted with "Logo" and "LANNETT" on the cap and 1326 on the body. Bottles of 100, NDC 0527-1326-01 Store at 20°-25° C (68° -77° F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP with a child-resistant closure. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70329D Rev. 07/23
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for Ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, Ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment re-evaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).