What is the appropriate pediatric dose of trypsin (or pancreatin) for a 28‑kg child?

Trypsin Dosing for a 28 kg Child

For a 28 kg child, the appropriate dose of trypsin (as an oral digestive enzyme supplement) is 10 drops in a little water, twice daily, based on FDA labeling for children 6-12 years of age. 1

Standard Pediatric Dosing

The FDA-approved dosing for oral trypsin follows age-based guidelines rather than weight-based calculations 1:

• Children 6-12 years: 10 drops in a little water, 2 times per day 1
• Children under 6 years: 5 drops in a glass of water, 2 times per day 1
• Children 12 years and older/Adults: 20 drops in a little water, 2 times per day 1

A 28 kg child typically falls within the 6-12 year age range, making 10 drops twice daily the appropriate dose 1.

Clinical Context: Pancreatic Enzyme Replacement

If trypsin is being considered as part of pancreatic enzyme replacement therapy (PERT) rather than as a standalone supplement, the approach differs significantly. Pancrelipase (which contains trypsin as protease along with lipase and amylase) is the appropriate therapeutic agent for pancreatic insufficiency 2.

For PERT in specific conditions like Glycogen Storage Disease Type III:

• Pancrelipase may be used with cornstarch to aid digestion and reduce side effects such as gas, bloating, and diarrhea in infants under 12 months who cannot fully digest cornstarch due to immature amylase production 2
• The combination helps improve tolerance of dietary interventions 2

Important Caveats and Pitfalls

Do not confuse standalone trypsin supplements with FDA-approved pancreatic enzyme replacement products 3:

• Over-the-counter enzyme supplements are not equivalent to prescription PERT formulations 3
• If treating pancreatic insufficiency, use FDA-approved PERT products (Creon, Zenpep, Pancreaze, Pertzye, or Viokace) rather than isolated trypsin 3

Administration timing is critical 3:

• Enzymes must be taken during meals, not before or after, to maximize mixing with food 3
• Never add enzymes directly to bottles or feeding tubes 3
• Do not crush or chew enteric-coated formulations as this destroys acid protection 3

Safety Considerations

Trypsin from porcine pancreas is generally safe for use in children 4:

• The primary safety concern is potential hypersensitivity reactions, though allergic reactions to porcine pancreatic enzymes in hydrolyzed foods are rarely reported 4
• The risk of allergic sensitization in infants is considered low but cannot be completely excluded 4
• Clinical studies identify hypersensitivity as the major side effect of pancreatic enzyme pharmaceuticals 4

Weight-Based Dosing Considerations

While the FDA label for trypsin uses age-based dosing 1, it's worth noting that pediatric drug dosing based solely on weight (mg/kg) can be inaccurate 5, 6:

• Weight-based scaling from adult doses results in doses too small for infants and children because elimination doesn't change in direct proportion to weight 6
• Children 2 years and older are essentially similar to adults in terms of drug metabolism maturation and differ primarily in size 6
• For a 28 kg child, age-based dosing as provided in the FDA label is the appropriate approach 1