Drug Catalog - Product Detail
Ursodiol Cap 300 MG 100 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 10702-0237-01 | KVK TECH | 100 | 300MG | CAPSULE |
PACKAGE FILES
Generic Name
URSOSIOL
Substance Name
URSADIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA210707
Description
DESCRIPTION Ursodiol Capsules, USP is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP is 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,7β-Dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below: Inactive Ingredients: Colloidal silicon dioxide, corn starch and magnesium stearate. Gelatin capsules contain red iron oxide, gelatin, and titanium dioxide. The capsules are printed with edible ink containing shellac, black iron oxide, propylene glycol, FD&C Blue # 2 aluminum lake, FD&C Red # 40 aluminum lake, D&C Yellow # 10 aluminum lake and FD&C Blue # 1 aluminum lake. chemical structure
How Supplied
HOW SUPPLIED Ursodiol Capsules, USP are pink opaque cap, white opaque body with black imprint “K237” on both cap and body containing white to off-white powder. Bottles of 100 are supplied with child-resistant closures. (NDC 10702-237-01) Store at 20 to 25°C (68 to 77°F); excursions permitted within 15 o to 30 o C (59 o to 86 o F). [see USP Controlled Room Temperature]. Dispense in tight container (USP). Keep out of reach of children. For all medical inquiries contact: KVK-Tech, Inc. Customer Service 1-215-579-1842 Manufactured by: KVK-Tech, Inc. 110 Terry Drive Newtown PA 18940 Manufacturer’s code: 10702 Item ID #: 6318/02 Rev.: 04/2020 company logo
Indications & Usage
INDICATIONS AND USAGE Ursodiol Capsules 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. 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 - 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 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.).