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Ursodiol (Ursodiol)

Trade Name : Ursodiol

Actavis Pharma, Inc.

TABLET

Strength 250 mg/1

URSODIOL Bile Acid [EPC],Bile Acids and Salts [CS]

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Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ursodiol (Ursodiol) which is also known as Ursodiol and Manufactured by Actavis Pharma, Inc.. It is available in strength of 250 mg/1 per ml. Read more

Ursodiol (Ursodiol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • nttu00a0u00a0u00a0u00a0u00a0ntUrsodiol tablets, USP 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
  • u00a0Ursodiol tablets, USP 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cirrhosis ()
  • No data
  • Recommended adult dosage: 13-15 mg/kg/day administered in two to four divided doses with food () n
  • Scored ursodiol tablets, USP 500 mg: scored tablet can be broken in halves to provide recommended dosageu00a0(, )
  • No data
  • Ursodiol tablets, USP 250 mg: 250 mg tablet ()n
  • Ursodiol tablets, USP 500 mg: 500 mg scored tablet ()
  • nttu00a0u00a0u00a0u00a0u00a0ntPatients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.
  • Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation ()
  • nttu00a0u00a0u00a0u00a0u00a0ntPatients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment.
  • nttu00a0u00a0u00a0u00a0u00a0ntLiver function tests (u03b3-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels.
  • nttu00a0u00a0u00a0u00a0u00a0ntCaution has to be exercised to maintain the bile flow of the patients taking ursodiol.
  • Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment ().n
  • Liver function tests (u03b3-GT, alkaline phosphatase, AST, ALT) and bilirubin level should be monitored. Treatment discontinuation should be considered if parameters increase to a level considered clinically significant in patients with stable historical liver function test levels ().n
  • Caution should be exercised to maintain patientsu2019 bile flow ().
  • Most common adverse reactions reported with the use of ursodiol during worldwide postmarketing and clinical experience (u22651%) are, in alphabetical order: abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, and rash ()
  • No data
  • Bile Acid Sequestering Agents: May interfere with the action of ursodiol tablets, USP 250 mg and 500 mg by reducing its absorption ()n
  • Aluminum-based Antacids: May interfere with the action of ursodiol tablets, USP 250 mg and 500 mg by reducing its absorption ()n
  • Drugs that alter the metabolism of lipids or induce cholestasis may interfere with the action of ursodiol tablets, USP 250 mg and 500 mg ()
  • No data
  • nttu00a0u00a0u00a0u00a0u00a0ntThere have been no reports of accidental or intentional overdosage with ursodiol. Single oral doses of ursodiol at 10 g/kg in mice and dogs, and 5 g/kg in rats were not lethal. A single oral dose of ursodiol at 1.5 g/kg was lethal in hamsters. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters.
  • nttu00a0u00a0u00a0u00a0u00a0ntUrsodiol tablets, USP 250 mg is available as a film-coated tablet for oral administration.u00a0Ursodiol tablets, USP 500 mgu00a0is available as a scored film-coated tablet for oral administration.
  • Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3u03b1,7u00df-dihydroxy-5u00df-cholan-24-oic (CHO). Ursodiol has a molecular weight of 392.56. Its structure is shown below.
  • u00a0n
  • nttu00a0u00a0u00a0u00a0u00a0nt
  • Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, ethylcellulose, dibutyl sebacate, carnauba wax, hydroxypropyl methylcellulose, PEG 3350, PEG 8000, cetyl alcohol, sodium lauryl sulfate and hydrogen peroxide.
  • No data
  • nttu00a0u00a0u00a0u00a0u00a0ntIn two 24-month oral carcinogenicity studies in mice, ursodiol at doses up to 1,000 mg/kg/day (3,000 mg/m/day) was not tumorigenic. Based on body surface area, for a 50 kg person of average height (1.46 m body surface area), this dose represents 5.4 times the recommended maximum clinical dose of 15 mg/kg/day (555 mg/m/day).
  • nttu00a0u00a0u00a0u00a0u00a0ntIn a two-year oral carcinogenicity study in Fischer 344 rats, ursodiol at doses up to 300 mg/kg/day (1,800 mg/m/day, 3.2 times the recommended maximum human dose based on body surface area) was not tumorigenic.
  • nttu00a0u00a0u00a0u00a0u00a0ntIn a life-span (126-138 weeks) oral carcinogenicity study, Sprague-Dawley rats were treated with doses of 33 to 300 mg/kg/day, 0.4 to 3.2 times the recommended maximum human dose based on body surface area. Ursodiol produced a significantly (p0.5, Fisher's exact test) increased incidence of pheochromocytomas of the adrenal medulla in females of the highest dose group.
  • nttu00a0u00a0u00a0u00a0u00a0ntIn 103-week oral carcinogenicity studies of lithocholic acid, a metabolite of ursodiol, doses up to 250 mg/kg/day in mice and 500 mg/kg/day in rats did not produce any tumors. In a 78-week rat study, intrarectal instillation of lithocholic acid (1 mg/kg/day) for 13 months did not produce colorectal tumors. A tumor-promoting effect was observed when it was administered after a single intrarectal dose of a known carcinogen N-methyl-N'-nitro-N-nitrosoguanidine. On the other hand, in a 32-week rat study, ursodiol at a daily dose of 240 mg/kg (1,440 mg/m, 2.6 times the maximum recommended human dose based on body surface area) suppressed the colonic carcinogenic effect of another known carcinogen azoxymethane.
  • nttu00a0u00a0u00a0u00a0u00a0ntUrsodiol was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y, TK+/-) forward mutation test, the human lymphocyte sister chromatid exchange test, the mouse spermatogonia chromosome aberration test, the Chinese hamster micronucleus test and the Chinese hamster bone marrow cell chromosome aberration test.
  • nttu00a0u00a0u00a0u00a0u00a0ntUrsodiol at oral doses of up to 2,700 mg/kg/day (16,200 mg/m/day, 29 times the recommended maximum human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
  • No data
  • No data
  • No data
  • Principal Display Panel
  • NDC 0591-2998-01
  • Ursodiol Tablets, USP
  • 250 mg
  • 100 Tablets
  • Rx only
  • Principal Display Panel
  • NDC 0591-3005-01
  • Ursodiol Tablets, USP
  • 500 mg
  • 100 Tablets
  • Rx only

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