Pancreatin

Registered South African indications: 

• Pancreatic exocrine insufficiency

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to pig proteins
• Early stages of acute pancreatitis (due to the fact that patients are not allowed to eat for the first 2-3 days)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• High doses

Forms avail. in SA and covered in this monograph: cap

Pancreatic exocrine insufficiency

• Oral (cap): 150-600mg; Titrate according to individual requirements; Maintenance: 150-300mg, 8hrly

Taken with or immediately after meals 

Swallow capsule whole or open capsule and administer pellets with a spoon

Pellets should not be chewed but swallowed whole

Pellets can be given with acidic fluid/ soft food

Very high doses may be associated with a fibrosing colonopathy

Paed forms avail. in SA and covered in this monograph: cap

Pancreatic exocrine insufficiency

• Oral (cap): See adult dosage

Children with cystic fibrosis who are taking >10 000 units of lipase/kg/day are at risk of developing colon damage

Pregnancy 

• Caution
• For pancreatic enzymes no clinical data on exposed pregnancies are available.  Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected
• Caution should be exercised when prescribing to pregnant women. If required during pregnancy, pancreatic enzymes should be used in doses sufficient to provide adequate nutritional status

Breastfeeding 

• Caution
• No effects on the breastfeeding child are anticipated since animal studies suggest no systemic exposure of the breastfeeding woman to pancreatic enzymes
• If required during breastfeeding, pancreatic enzymes should be used in doses sufficient to provide adequate nutritional status

Renal impairment 

• Caution; no dose adjustment recommended

Hepatic impairment

• No dose adjustment recommended 

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Constipation
• Abdominal distention
• Diarrhoea
• Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) 

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity 
• Anaphylactic reactions

No information available

None routine

Pancreatin substitutes pancreatic enzymes if they are deficient. The capsules dissolve rapidly in the stomach releasing the enzyme in minimicrospheres. When the minimicrospheres reach the small intestine the coating rapidly disintegrates to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or absorbed following further hydrolysis by intestinal enzymes.

Capsule 150mg

• Creon 10000 (Abbott) originator

Capsule 300mg

• Creon 25000 (Abbott) originator