Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

URSODIOL

×

Overview

What is URSODIOL?

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 (CHO). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below:

Inactive Ingredients:



What does URSODIOL look like?



What are the available doses of URSODIOL?

Sorry No records found.

What should I talk to my health care provider before I take URSODIOL?

Sorry No records found

How should I use URSODIOL?

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 1-3 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 therapy, the likelihood of success is greatly reduced.


What interacts with URSODIOL?

Sorry No Records found


What are the warnings of URSODIOL?

Sorry No Records found


What are the precautions of URSODIOL?

Sorry No Records found


What are the side effects of URSODIOL?

Sorry No records found


What should I look out for while using URSODIOL?


What might happen if I take too much URSODIOL?

Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16-20 mg/kg/day have been tolerated for 6-37 months without symptoms by 7 patients. The LD for ursodiol in rats is over 5000 mg/kg given over 7-10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.


How should I store and handle URSODIOL?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808Ursodiol Capsules USP, 300 mg are opaque white capsules imprinted on one half and on the other half of the capsule in black. Bottles of 100 are supplied with child-resistant closures.Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).Dispense in a tight container (USP).Rx onlyKeep out of reach of children.Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Corona, CA 92880 USARevised: August 20082000700-00S0808


×

Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and also inhibits intestinal absorption of cholesterol. It appears to have little inhibitory effect on synthesis and secretion into bile of endogenous bile acids, and does not appear to affect secretion of phospholipids into bile.

With repeated dosing, bile ursodeoxycholic acid concentrations reach a steady state in about 3 weeks. Although insoluble in aqueous media, cholesterol can be solubilized in at least two different ways in the presence of dihydroxy bile acids. In addition to solubilizing cholesterol in micelles, ursodiol acts by an apparently unique mechanism to cause dispersion of cholesterol as liquid crystals in aqueous media. Thus, even though administration of high doses (e.g., 15-18 mg/kg/day) does not result in a concentration of ursodiol higher than 60% of the total bile acid pool, ursodiol-rich bile effectively solubilizes cholesterol. The overall effect of ursodiol is to increase the concentration level at which saturation of cholesterol occurs.

The various actions of ursodiol combine to change the bile of patients with gallstones from cholesterol-precipitating to cholesterol-solubilizing, thus resulting in bile conducive to cholesterol stone dissolution.

After ursodiol dosing is stopped, the concentration of the bile acid in bile falls exponentially, declining to about 5%-10% of its steady-state level in about 1 week.

Non-Clinical Toxicology
Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of ursodiol.

Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver-toxic metabolite. This bile acid is formed in the gut from ursodiol less efficiently and in smaller amounts than that seen from chenodiol.

Lithocholic acid is detoxified in the liver by sulfation and, although man appears to be an efficient sulfater, it is possible that some patients may have a congenital or acquired deficiency in sulfation, thereby predisposing them to lithocholate-induced liver damage.

Abnormalities in liver enzymes have not been associated with ursodiol therapy and, in fact, ursodiol has been shown to decrease liver enzyme levels in liver disease. However, patients given ursodiol should have SGOT (AST) and SGPT (ALT) measured at the initiation of therapy and thereafter as indicated by the particular clinical circumstances.

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

Rate this treatment and share your opinion


Learn about User Reviews

Helpful tips to write a good review:

  1. Only share your first hand experience as a consumer or a care giver.
  2. Describe your experience in the Comments area including the benefits, side effects and how it has worked for you. Do not provide personal information like email addresses or telephone numbers.
  3. Fill in the optional information to help other users benefit from your review.

Reason for Taking This Treatment

(required)

Click the stars to rate this treatment

Effectiveness (required)

This medication has worked for me.




Ease of Use (required)

This medication has been easy for me to use.




Satisfaction (required)

Overall, I have been satisfied with my experience.




Write a brief description of your experience with this treatment:

2000 characters remaining

Optional Information

Help others benefit from your review by filling in the information below.
I am a:
Gender:
×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
×

Tips

Tips

×

Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).