Urso (Ursodeoxycholic acid - ursodiol) - Drug Information

Urso (Ursodiol, Ursodeoxycholic acid) reduces the amount of cholesterol found in bile and bile stones by reducing the amounts of cholesterol secreted by the liver and partially absorbed by the intestines.

It is used in the treatment of the following conditions:

  • Gallstones (capsules only):
    • When an elective cholecystectomy would be performed on a patient with radiolucent, noncalcified gallbladder stones fewere than 20 mm in diameter, it would be used to treat them unless doing so would increase their surgical risk because of a rare reaction to general anesthesia, a systemic disease, advanced age, or a patient's decision to forego surgery.
    • In obese patients who are losing weight quickly, it is used to prevent the development of gallstones.
  • Primary biliary cirrhosis (tablets only):
    • It is used to treat people who have PBC, or primary biliary cirrhosis.
  • Off Label Use of Adults:
    • It prevents gallstones after bariatric surgery.

The other medicine used in the treatment and prevention of gallstones is chenodeoxycholic acid (Chenodiol).

Urso (Ursodiol) Dose in Adults

For the treatment of gallstones, urso (Actigall) dosage:

  • oral administration of 2 to 3 divided doses of 8 to 10 mg/kg/day

 


Using Urso off-label to treat and prevent gallstones after bariatric surgery:

  • For six months, take 500 to 600 mg orally once daily, either all at once or in two doses.

 


Using Actigall's urso dose to prevent gallstones:

  • twice daily administration of 300 mg

 


Urso dosage (Urso, Urso Forte) for the management of primary biliary cirrhosis:

  • Orally administered in divided doses of two to four mg/kg/day (with food).

Urso (Ursodiol) Dose in Children

Dose for the management of biliary atresia in the status following Kasai surgery: 

  • Children and Infants:
    • Orally administered in doses of two to three, between 10-20 mg per kg per day.

 


Treatment of cholestasis-related pruritus with urso dose 

  • Infants, kids, and teenagers:
    • Oral administration of 15-20 mg per kg per day, either once daily or in divided doses twice daily
    • Some patients may need doses as high as 30 mg per kg per day.

 


Urso dose for the treatment of liver disease associated with cystic fibrosis:

  • Infants, young children, and teenagers
    • Initial: Orally administered in two divided doses at 20 mg per kg per day
    • According to reports, doses should be divided between 10 and 30 mg per kg per day.

 


Treatment of cholestasis brought on by parenteral nutrition with Urso: 

  • Children and Infants:
    • 30 mg/kg/day given orally in three separate doses

Urso Pregnancy Risk Factor: B

  • Animal reproduction studies have not shown any adverse events.

Urso (Ursodiol) use during breastfeeding:

  • It is unknown if ursodiol can be excreted in breast milk or not.
  • The manufacturer suggests that breastfeeding mothers exercise caution when giving ursodiol.

Urso (Ursodiol) Dose in Renal Disease:

  • There are no dosage adjustments given in the manufacturer’s labelling.

Urso (Ursodiol) Dose in Liver Disease:

  • There are no dosage adjustments given in the manufacturer’s labelling.

Common Side Effects of Ursodiol (Urso) Include:

  • Respiratory:
    • Upper Respiratory Tract Infection
  • Central Nervous System:
    • Headache
    • Dizziness
  • Neuromuscular & Skeletal:
    • Back Pain
  • Gastrointestinal:
    • Dyspepsia
    • Nausea
    • Diarrhea
    • Constipation

Less Common Side Effects of Urso (Ursodiol) Include:

  • Gastrointestinal:
    • Vomiting
    • Peptic Ulcer
  • Genitourinary:
    • Urinary Tract Infection
  • Dermatologic:
    • Alopecia
    • Skin Rash
  • Hepatic:
    • Cholecystitis
  • Hypersensitivity:
    • Hypersensitivity Reaction
  • Endocrine & Metabolic:
    • Hyperglycemia
  • Hematologic & Oncologic:
    • Leukopenia
    • Thrombocytopenia
  • Infection:
    • Viral Infection
  • Renal:
    • Increased Serum Creatinine
  • Neuromuscular & Skeletal:
    • Arthritis
    • Musculoskeletal Pain
  • Respiratory:
    • Pharyngitis
    • Bronchitis
    • Cough
    • Flu-Like Symptoms

Contraindications to Urso (Ursodiol) include:

  • hypersensitivity to any of the formulation's ingredients, including ursodiol
  • patients with pancreatitis brought on by gallstones, biliary-gastrointestinal fistula, acute cholecystitis, chronic cholangitis, or biliary obstruction
  • Not recommended for use with radiolucent, radiopaque, or calcium-calcified cholesterol stones or stones made of bile pigment.
  • Totally blocked bile due to extrahepatic causes
  • obstruction of the liver that is widespread
  • sensitivity to bile acid

Warnings and precautions

  • Obstructive biliary:
    • As you receive treatment, keep your bile flowing to prevent biliary obstruction.
  • Hepatic effects
    • Patients with chronic liver conditions need to exercise caution.
    • Liver function tests should be monitored every month for the first three months, then every six months going forward, or as determined by clinical judgment.
    • Therapy may need to be stopped if liver function tests reveal significant elevations.

Monitor:

Primary biliary cirrhosis:

  • After the first three months, liver function tests, such as ALT, AST, GGT, bilirubin, and alkaline phosphatase, should be monitored monthly or as clinically necessary.

How to administer Urso (Ursodiol)?

  • Avoid administering antacids or bile acid sequestrants that contain aluminum.
  • If you need to take antacids with aluminum, do so two hours after taking ursodiol.
  • Some medical professionals advise taking ursodiol an hour before or four to five hours after taking bile acid sequestrants.
  • Urso Forte can be divided into two equal parts for the administration of the proper dose.
  • avoid chewing.
  • It is best to eat before taking Urso Forte and Urso.

Mechanism of action of Ursodiol:

  • By reducing cholesterol production and fractional reabsorption by the intestines, ursodiol lowers cholesterol levels in bile and kidney stones.
  • The exact mechanism underlying primary biliary dysfunction is unknown.

Absorption:

  • 90%

Protein binding:

  • ~70%

Metabolism:

  • It undergoes extensive enterohepatic recycling.
  • Ursodiol is conjugated in the liver before being hydrolyzed to active ursodiol, which is then recycled or transformed into lithocholic acid by the colonic microbial flora.
  • Ursodiol becomes a significant biliary and plasma bile acid over the course of prolonged administration, making up 30% to 50% of biliary and plasma bile acids.

Excretion:

  • By Feces; urine (<1% 

International Brands of Ursodiol:

  • Actigall
  • Urso 250
  • Urso Forte
  • DOM-Ursodiol C
  • JAMP-Ursodiol
  • PHL-Ursodiol C [DSC]
  • PMS-Ursodiol
  • PMS-Ursodiol C
  • Urso
  • Urso DS
  • Actigall
  • Adursal
  • Canlin
  • Cholemax
  • Destolit
  • Deursil
  • Dexo
  • Dozurso
  • Estazor
  • Galcholic
  • Homan
  • Lupible
  • Taurolite
  • Triptor
  • Udihep
  • Uldeso
  • Urdafalk
  • Urdek
  • Urosan
  • Ursa
  • Ursacol
  • Ursilon
  • Ursimex
  • Urso
  • Ursobilane
  • Ursocel
  • Ursochol
  • Ursodamor
  • Ursodox
  • Ursofalk
  • Ursolic
  • Ursolin
  • Ursolit
  • Ursoliv
  • Ursolvan
  • Ursopol
  • Ursosan

Ursodiol (Ursodeoxycholic Acid) brands in Pakistan:

Ursodeoxycholic Acid [Caps 250 Mg]

Triptor

Consolidated Chemical Laboratories (Pvt) Ltd.

Urso

Agp (Private) Ltd.

Ursofalk

Agp (Private) Ltd.

Ursogal

Shrooq Pharmaceuticals

Ursox

Genome Pharmaceuticals (Pvt) Ltd

 

Urso (Ursodeoxycholic Acid) [Caps 500 Mg]

Triptor

Consolidated Chemical Laboratories (Pvt) Ltd.

Urso

AGP (Private) Ltd.

Ursogal

Shrooq Pharmaceuticals