Ursodiol (Ursodiol)

Trade Name : Ursodiol

AvPAK

CAPSULE

Strength 300 mg/1

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

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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 AvPAK. It is available in strength of 300 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

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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
  • Prescribing Information
  • SPECIAL NOTE
  • Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.
  • 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 3u03b1,7u03b2- Dihydroxy-5u03b2-cholan-24-oic acid (Cn n n Hn n n On n n ). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below:n nn
  • Inactive Ingredients:
  • The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, propylene glycol and shellac glaze.
  • About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large u201cfirst-passu201d effect) where it is conjugated with either glycine or taurine and is then secreted into the hepatic bile ducts. Ursodiol in bile is concentrated in the gallbladder and expelled into the duodenum in gallbladder bile via the cystic and common ducts by gallbladder contractions provoked by physiologic responses to eating. Only small quantities of ursodiol appear in the systemic circulation and very small amounts are excreted into urine. The sites of the drugu2019s therapeutic actions are in the liver, bile, and gut lumen.
  • Beyond conjugation, ursodiol is not altered or catabolized appreciably by the liver or intestinal mucosa. A small proportion of orally administered drug undergoes bacterial degradation with each cycle of enterohepatic circulation. Ursodiol can be both oxidized andreduced at the 7-carbon, yielding either 7-keto-lithocholic acid or lithocholic acid, respectively. Further, there is some bacterially catalyzed deconjugation of glyco- and tauro-ursodeoxycholic acid in the small bowel. Free ursodiol, 7-keto-lithocholic acid, and lithocholic acid are relatively insoluble in aqueous media and larger proportions of these compounds are lost from the distal gut into the feces. Reabsorbed free ursodiol is reconjugated by the liver. Eighty percent of lithocholic acid formed in the small bowel is excreted in the feces, but the 20% that is absorbed is sulfated at the 3-hydroxyl group in the liver to relatively insoluble lithocholyl conjugates which are excreted into bile and lost in feces. Absorbed 7-keto-lithocholic acid is stereospecifically reduced in the liver to chenodiol.
  • The 7-dehydroxylation reaction appears to be alpha-specific, i.e., chenodiol is more efficiently 7-dehydroxylated than ursodiol and, for equimolar doses of ursodiol and chenodiol, levels of lithocholic acid appearing in bile are lower with the former. Man has the capacity to sulfate lithocholic acid. Although liver injury has not been associated with ursodiol therapy, a reduced capacity to sulfate may exist in some individuals, but such a deficiency has not yet been clearly demonstrated.
  • 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 cholesterolsolubilizing, 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.
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  • 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:
  • 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 LDn n n 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.n nn
  • No data
  • Ursodiol Capsules USP, 300 mg are opaque white and pink capsules, filled with white powder. They are imprinted
  • u201cu0404503u201d in black ink on cap and body and are supplied in blister packs of 50 count NDC 50268-796-15.
  • Store at 20u00b0 - 25u00b0C (68u00b0 - 77u00b0F) [see USP Controlled Room Temperature]. Dispensed in a blister punch material for Institutional Use Only.
  • Keep out of reach of children.
  • Manufactured For:
  • AvPAK
  • A Division of AvKARE, Inc.
  • Pulaski, TN 38478
  • Mfg. Iss. 05/10
  • AV 07/12
  • NDC 50268-796-15n n n n Rx Onlyn n n 50 Capsules (5 X 10) Unit Dosen n n n 5026879615n n n n n
  • NDC 50268-796-15n n n n Rx Onlyn n n 50 Capsules (5 X 10) Unit Dosen n n n 5026879615n n n n
  • Each capsule contains:n n n Ursodiol, USP...........300 mgn n n n USUAL DOSAGE: See accompanying literature for complete prescribing information. n nn
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [see USP Controlled Room Temperature]. n n n n Dispense contents in a tight, light-resistant package as defined in the USP. n n n n KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.n nn
  • Manufactured for:n n n AvKARE, Inc.n n n Pulaski, TN 38478n nn
  • AvPAKn n n n

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