Finished product reference

Pancreatin

Capsule, Delayed Release Pellets · Oral · 10000 IU

List code
50404
Pharmacologic class
Pancreatic enzyme replacement (porcine lipase, protease and amylase)

What it is and how it works

Pancreatin contains pancreatic enzymes of porcine origin that hydrolyse fats, proteins and starch in the duodenum, compensating for deficient exocrine pancreatic secretion; enteric-coated microspheres protect the enzymes from gastric acid.

Indications

Exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, gastrectomy, pancreatic cancer or other causes.

Dosage and administration (summary)

Oral, with meals and snacks; dosing is expressed in lipase units and individualised according to fat intake, symptoms and steatorrhoea, typically starting at about 25,000–40,000 lipase units per main meal in adults.

Contraindications

Hypersensitivity to porcine protein or any component.

Warnings and precautions

Fibrosing colonopathy has been reported in children with cystic fibrosis taking high doses, generally above 10,000 lipase units/kg daily. Capsules should be swallowed whole or the granules mixed with acidic soft food without chewing, to avoid mucosal irritation and enzyme inactivation. Contains material of porcine origin; high doses may cause hyperuricosuria.

Pregnancy

Not absorbed systemically; may be used in pregnancy when needed to maintain nutrition.

Storage and supply

Store below 25 °C in a tightly closed container, protected from moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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