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Ursodiol (Actigall)

Trade Name : Actigall

Allergan, Inc.

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 (Actigall) which is also known as Actigall and Manufactured by Allergan, Inc.. It is available in strength of 300 mg/1 per ml. Read more

Ursodiol (Actigall) 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
  • Actigall is a bile acid available as 300 mg capsules suitable for oral administration.
  • Actigall is ursodiol, USP (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 3u03b1,7u03b2-Dihydroxy-5u03b2-cholan-24-oic acid (CHO). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below:
  • Inactive Ingredients:
  • About 90% of a therapeutic dose of Actigall 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 and reduced 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.
  • Lithocholic acid causes cholestatic liver injury and can cause death from liver failure in certain species unable to form sulfate conjugates. Lithocholic acid is formed by 7-dehydroxylation of the dihydroxy bile acids (ursodiol and chenodiol) in the gut lumen. 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.
  • No data
  • No data
  • No data
  • No data
  • 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 Actigall has been reported. Doses of Actigall in the range of 16u00a0-u00a020 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with Actigall would probably be diarrhea, which should be treated symptomatically.
  • No data
  • Actigall Capsules are opaque white and pink capsules imprinted u201cACTIGALLu201d on one half and u201c300 mgu201d on the other half of the capsule in black.
  • Bottles of 100 are supplied with child-resistant closures.n n n n n
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F).
  • Dispense in a tight container (USP).
  • Keep out of reach of children.
  • Rx only
  • Distributed by:
  • Allergan USA, Inc.
  • Madison, NJ 07940
  • u00a9 2018 Allergan. All rights reserved.
  • ACTIGALL is a registered trademark of Allergan Sales, LLC.
  • Allergan and its design are trademarks of Allergan, Inc.
  • Revised: May 2018
  • v1.0USPI6145
  • NDC 0023-6145-01Actigalln (ursodiol, USP) capsules300 mg100 capsulesRx only

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