Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Ursodeoxycholic acid

Generic name
Ursodeoxycholic acid
Brand name
ATC Code
A05AA02

Pharmacokinetics in children

The following kinetic parameters have been found in neonates aged 1-51 days after administering microdoses (Gordi et al. 2014):

Dose

Cmax (pg/ml)

avg. (median)

Cl/F (ml/hour)

avg. (median)
8 ng (n=5) 7 (6) 47 (60)
26 ng (n=5) 28 (25) 51 (31)
80 ng (n=6) 85 (69) 33 (30)
total (n=16) - 43 (26)

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Cholestasis
  • Oral
    • Premature infants Gestational age < 37 weeks
      • 10 - 30 mg/kg/day in 2 - 3 doses.
    • Term neonate
      • 15 - 30 mg/kg/day in 2 - 3 doses.
Hepatobiliary complaints in cystic fibrosis
  • Oral
    • 1 month up to 18 years
      • 20 - 30 mg/kg/day in 2 - 3 doses.
      • Directions for administration:

        Take after a meal

    • 1 month up to 18 years
      • 20 - 30 mg/kg/day in 2 - 3 doses.
      • Directions for administration:

        Take after a meal
Gallstones
  • Oral
    • 1 month up to 18 years
      • 8 - 10 mg/kg/day in 1 dose
      • Duration of treatment:

        6 months to 2 years

      • Directions for administration:

        Take before going to bed

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Diarrhoea

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Severe renal function disorders, acute gastric and duodenal ulcers.
Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia [SmPC Ursofalk, 11/2020].

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Bile secretion increases when ursodeoxycholic acid is used and caution is therefore needed in conditions with limited bile secretion. Treatment should be discontinued if the concentrations of alkaline phosphatase, γ-GT and bilirubin increase after the start of the treatment

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Other drugs for bile therapy
A05AX04
A05AX05

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References

  1. Al-Hathlol K, et al, Ursodeoxycholic acid therapy for intractable total parenteral nutrition-associated cholestasis in surgical very low birth weight infants, Singapore Med J., 2006, 47, 147-51
  2. Arslanoglu S, et al, Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition., J Pediatr Gastroenterol Nutr, 2008, 46, 228-31
  3. Chen CY, et al, Ursodeoxycholic acid (UDCA) therapy in very-low-birth-weight infants with parenteral nutrition-associated cholestasis, J Pediatr, 2004, 145, 317-21
  4. Cheng K, et al, Ursodeoxycholic acid for cystic fibrosis-related liver disease., Cochrane Database Syst Rev, 2014 Dec 15, 12, CD000222
  5. De Marco G, et al, Early treatment with ursodeoxycholic acid for cholestasis in children on parenteral nutrition because of primary intestinal failure, Aliment Pharmacol Ther, 2006, 24, 387-94
  6. Galabert C, et al, Effects of ursodeoxycholic acid on liver function in patients with cystic fibrosis and chronic cholestasis, J Pediatr., 1992, 121, 138-41
  7. Levine A, et al, Parenteral nutrition-associated cholestasis in preterm neonates: evaluation of ursodeoxycholic acid treatment [abstract]., J Pediatr Endocrinol Metab., 1999, 12, 549-53
  8. Lepage G, et al, Ursodeoxycholic acid improves the hepatic metabolism of essential fatty acids and retinol in children with cystic fibrosis, J Pediatr., 1997, 130, 52-8
  9. Nousia-Arvanitakis S, et al, Long-term prospective study of the effect of ursodeoxycholic acid on cystic fibrosis-related liver disease, J Clin Gastroenterol, 2001, 32, 324-8
  10. Spagnuolo MI, et al, Ursodeoxycholic acid for treatment of cholestasis in children on long-term total parenteral nutrition: a pilot study. ;:., Gastroenterology., 1996, 111, 716-9
  11. Tramedico BV. ., SPC Ursodeoxycholzuur 15-3-2013, www.cbg-meb.nl
  12. Gordi T et al., Pharmacokinetic Analysis of 14C-ursodiol in Newborn Infants Using Accelerator Mass Spectrometry, J Clin Pharmacol, 2014, Sep;54(9), 1031-7
  13. Dr. Falk Pharma Benelux BV, SmPC Ursochol suspensie (RVG 101647) 05-03-2015, www.cbg-meb.nl
  14. Honar N et al., Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy, J Pediatr Gastroenterol Nutr., 2016, jan;62(1), 97-100
  15. Zambon GmbH, SmPC Ursochol® 300 mg Tabletten (37567.00.00), 03/17
  16. Zambon GmbH, SmPC Ursochol® 150 mg Tabletten (1527.00.00), 03/17
  17. Uptodate: UpToDate®, Pediatric Drug information: Ursodeoxycholsäure Lexicomp® Topic 12872 Version 153.0, accessed 01/19
  18. Dr. Falk Pharma, SmPC, Ursofalk 250 mg Kapseln (39200.00.00), 06/16
  19. Dr. Falk Pharma, SmPC, Ursofalk 250 mg/5 ml Suspension zum Einnehmen (39200.00.01), 05/14
  20. Hexal AG, SmPC, UDC 250/400 mg Filmtabletten (8799.00.00/8799.10.00), 02/14
  21. Dr. Falk Pharma, SmPC, Ursofalk 500 mg Filmtabletten (54690.00.00), 04/17

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Changes

Changes