Actigall


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ursodiol

(er-soe-dye-ole) ,

Actigall

(trade name),

Urso 250

(trade name),

Urso

(trade name),

Urso DS

(trade name),

Urso Forte

(trade name)

Classification

Therapeutic: gallstone dissolution agents
Pregnancy Category: B

Indications

Gallbladder stone dissolution and prevention.Primary biliary cirrhosis.Biliary atresia.TPN-induced cholestasis.

Action

↓ cholesterol content of bile and bile stones by suppressing cholesterol synthesis and secretion from the liver and inhibits intestinal absorption of cholesterol.

Therapeutic effects

Gallstone dissolution and reduction in gallstone formation.
↓ progression of liver disease and improvement in liver function tests.

Pharmacokinetics

Absorption: 90%.
Distribution: Only small quantities are found in the systemic circulation; sites of action include the liver, bile, and gut lumen.
Protein Binding: 70%.
Metabolism and Excretion: Undergoes extensive enterohepatic recycling; excreted in feces via bile.
Half-life: 100 hr.

Time/action profile

ROUTEONSETPEAKDURATION
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Contraindications/Precautions

Contraindicated in: Patients requiring cholecystectomy; Calcified cholesterol stones, radiopaque stones, bile pigment stones, or stones >20 mm;Complete biliary obstruction.
Use Cautiously in: Chronic liver disease.

Adverse Reactions/Side Effects

Central nervous system

  • anxiety
  • depression
  • fatigue
  • headache
  • sleep disorder

Dermatologic

  • hair thinning
  • pruritus
  • rash

Gastrointestinal

  • abdominal/biliary pain
  • constipation
  • diarrhea
  • flatulence
  • jaundice
  • ↑ liver enzymes
  • nausea
  • stomatitis
  • vomiting

Neurologic

  • arthralgias
  • myalgia

Respiratory

  • cough
  • rhinitis

Interactions

Drug-Drug interaction

Cholestyramine, colestipol, and aluminum-containing antacids may ↓ absorption.Estrogens may ↓ its effectiveness.

Route/Dosage

Oral (Adults) Gallstone dissolution—Initial 8–10 mg/kg/day in 2–3 divided doses; maintenance: 250 mg/day at bedtime for 6 mo–1 yr; Gallstone prevention—300 mg twice daily; Primary biliary cirrhosis—13–15 mg/kg/day in 2–4 divided doses.
Oral (Children and Infants) TPN-induced cholestasis—30 mg/kg/day in 2–3 divided doses.
Oral (Infants) Biliary atresia—10–15 mg/kg/day.

Availability (generic available)

Capsules: 300 mg
Tablets: 250 mg, 500 mg

Nursing implications

Nursing assessment

  • Monitor abdominal pain prior to and periodically during therapy.
  • Monitor ultrasonograms at 6 mo intervals during the first year of therapy.
  • Lab Test Considerations: Monitor liver function tests (GGT, alkaline phosphatase, AST, ALT) and bilirubin levels every mo for three mo and every six mo thereafter. If increase to clinically significant levels, consider discontinuation of therapy.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Administer with food. Tablets may be broken in half and swallowed with water. To minimize the bitter taste, advise patient to swallow the half-tablet quickly without chewing. Half-tablets should be stored separately for up to 28 days.

Patient/Family Teaching

  • Instruct patient to take ursodiol as directed.
  • Advise patient to avoid aluminum-containing antacids during therapy; may impair absorption.

Evaluation/Desired Outcomes

  • Dissolution and reduction in formation of gallstones. May take several mo of therapy and complete dissolution may not occur. Stone recurrence may occur after dissolution.
  • ↓ progression of liver disease and improvement in liver function tests.

Actigall®

A drug used to dissolve gallstones as an alternative to cholecystectomy in patients with radiolucent, noncalcified gallstones ≤ 20 mm in diameter, and to prevent gallstone development in patients undergoing rapid weight loss. 
Contraindications Actigall does not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. It is useless for acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula.

Actigall®

Ursodiol, ursodeoxycholic acid An agent used to dissolve gallstones as an alternative to cholecystectomy in Pts with radiolucent, noncalcified gallstones ≤ 20 mm in diameter, and to prevent gallstone development in Pts undergoing rapid weight loss
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References in periodicals archive ?
4 days on 3 off, with doxycycline 100 mg, 2 tablets 2 x per day, and Actigall.
Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall Capsules.
Watson US rights to Actigall, Pharma which contains ursodiol, a naturally occurring bile acid, introduced in the U.
The medicinal benefits of bear gall are not denied in the west: Actigall, a synthetic form of ursodeoxycholic acid (UDCA) - the active ingredient in bear gall - is used to dissolve kidney stones and treat cirrhosis of the liver.
I am fairly stunned that the only thing given to protect the gallbladder and liver with the use of IV medications is Actigall, and some practitioners do not prescribe anything when giving IV treatment.
The new gallstone treatment combines Medstone's shockwave (lithotripsy) technology with short-term use of Actigall, a gallstone-dissolving drug made by Novartis Pharma AG (NYSE:NVS).
Nasdaq: MEDS) has been notified that the FDA's Gastroenterology and Urology Device Advisory Panel has recommended conditional approval of Medstone's submission to treat gallstones using the company's lithotripter, in combination with Actigall, a drug used to dissolve gallstones.
This new gallstone treatment therapy combines Medstone's lithotripsy technology with short-term use of Actigall, a gallstone dissolving drug manufactured by Novartis Pharma AG (NYSE: NVS).
Nasdaq: MEDS) Friday announced that the Food and Drug Administration (FDA) informed Medstone in writing that its Pre-market Approval Application to non-invasively treat gallstones, using the company's lithotripter in conjunction with Actigall (ursodiol USP), is considered filed.
ACTIGALL entered the US market approximately ten years before the related product, and has long been recognized in the medical community by the truncated term "urso" derived from the generic name.
Food & Drug Administration (FDA) to treat gallstones using the company's non-invasive lithotripter in conjunction with Actigall (ursodiol USP), a gallstone dissolution medication from Novartis Pharmaceuticals Corp.