Pancreatin

Generic name
Pancreatin
Brand name
ATC Code
A09AA02
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Pancreatin

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

There is no evidence that intact enzymes are absorbed. The degradation takes place proteolytically in the digestive tract.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Exocrine pancreatic insufficiency
  • Oral
    • < 1 year
      [2] [6] [7] [8]

      • 2000-4000 U lipase per 120 ml of food (bottle formula or breast feeding) and 2000 U lipase per gram of fat in supplementary feeding.

    • 1 year up to 4 years
      [2] [6] [7] [8]

      • 2000-4000 U lipase per gram of fat intake, max. 10,000 U lipase per kg/day

      • Titrate the dosage depending on the fat resorption coefficient and the pattern of symptoms (note the maximum dose).

    • ≥ 4 years
      [4] [6] [7] [8]

      • Start with 500 U lipase per kg bodyweight per meal. Max:

        • 1000-2500 U lipase per kg bodyweight per meal
        • 10,000 U lipase per kg bodyweight per day or
        • 2000-4000 U lipase per gram of fat intake for all meals, snacks and drinks or

      • Titrate the dosage further depending on the fat resorption coefficient and the pattern of symptoms (note the maximum dose).
Dissolving meconium
  • Rectal
    • Premature infants Gestational age < 37 weeks and < 1 kg
      [5]
      • Pancreatin 6NF powder 125 mg/dose, once only.

      • Dissolve in 5 ml of 0.9% NaCl

    • Premature infants Gestational age < 37 weeks and ≥ 1 kg
      [5]
      • Pancreatin 6NF powder: 250 mg/dose, once only.

      • Dissolve in 10 ml of 0.9% NaCl

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.

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

Frequency, type and severity of side effects in children with cystic fibrosis was similar compared to those in adults.

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

Contra-indications

No information available on specific contra indications in children.

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

A few cases of fibrotic changes in the colon with strictures and symptoms indicative of gastrointestinal obstruction (especially at > 10,000 FIP units of lipase/kg per day) have been reported in children with cystic fibrosis who used preparations with high doses of lipase for prolonged periods.
If the capsule cannot be swallowed, the capsule can be opened and the microgranules can be taken with a non-alkaline liquid (e.g. orange juice, apricot, banana or apple puree). The microgranules must not be chewed. The mouth must then be rinsed to avoid irritation. This can cause problems for children under 6 years of age (particularly infants): there is a risk of aspiration of the granules if the child resists or chokes on it.

In cases of absolute or relative insufficiency of the pancreas, pancreatin is used as a substitution product. This consists of a combination of amylase, protease and lipase. Pancreatic enzymes have an important role in the treatment of cystic fibrosis. The pancreatin capsules contain gastro-resistant micro-tablets. The coating of these micro-tablets also disguises the unpleasant taste. The capsules may be opened. The contents must not be chewed and should be taken with a non-alkaline liquid.
Preparations with high-dose lipase (25,000 FIP units/capsule) have recently been put on the market. On the one hand, they offer the advantage that fewer capsules need to be taken with meals, on the other hand the dosage in young children is more difficult. These new preparations are therefore above all appropriate for children ages older than 10 years.

Interactions

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

DIGESTIVES, INCL. ENZYMES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-formularium voor Kinderen, 2007
  2. Abbvie, SmPC Panzytrat granulaat (RVG 108240) 13-04-2022, www.geneesmiddeleninformatiebank.nl
  3. Janssen-Cilag BV, SPC Pancrease HL (RVG 16134), www.cbg-meb.nl, Geraadpleegd 19-05-14, http://db.cbg-meb.nl/IB-teksten/h16134.pdf
  4. Mylan Healthcare, SmPC Creon/Creon Forte (RVG 10656/10655) 03-02-2021, www.geneesmiddeleninformatiebank.nl
  5. Kneepkens CMF et al, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2002, 2e
  6. Mylan Healthcare, SmPC Creon granulaat (RVG 107907) 03-02-2021, www.geneesmiddeleninformatiebank.nl
  7. Turck, D et al, ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants children, amd adult with cystic fibrosis., Clinical Nutrition , 2016, 35, 557e577
  8. Turck D, et al., ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis,, Clin Nutr, 2016, Jun;35(3), 557-77

Changes

Therapeutic Drug Monitoring


Overdose