Drug Catalog - Product Detail
URSODIOL, USP CP 300MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-1730-01 | MYLAN | 100 | 300MG | CAPSULE |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Ursodiol Capsules, USP are 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 white or almost white crystalline powder freely soluble in alcohol and in glacial acetic acid, slightly soluble in acetone, methylene chloride, and ether, sparingly soluble in chloroform, and practically insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol has a molecular weight of 392.57. Its structure is shown below: Each capsule contains 300 mg of ursodiol, USP with the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Yellow No. 6, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Ursodiol Structural Formula
How Supplied
HOW SUPPLIED Ursodiol Capsules, USP are available containing 300 mg of ursodiol, USP. The 300 mg capsules are hard-shell gelatin capsules with a peach opaque cap and a white opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 1730 in black ink on both the cap and body. They are available as follows: NDC 0378-1730-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 5/2020 USDL:R4
Indications & Usage
INDICATIONS AND USAGE 1. Ursodiol capsules, USP are 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 capsules beyond 24 months is not established. 2. Ursodiol capsules are 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 capsules treatment of radiolucent gallbladder stones is 8 to 10 mg/kg/day given in two or three divided doses. Ultrasound images of the gallbladder should be obtained at 6 month intervals for the first year of ursodiol capsules therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol capsules 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 reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol capsules therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of ursodiol capsules for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).