Dosage/Direction for Use
Oral Exocrine pancreatic insufficiency Adult: In cases due to cystic fibrosis and other conditions (e.g. chronic pancreatitis or pancreatectomy): Usual dose with each meal: 5,000-56,000 units of lipase activity (with varying proportions of protease and amylase activity, depending on the preparation). Dose is individualised according to the individual needs, the amount and type of food consumed, and dosage form. Dosage recommendations may vary among individual products and between countries (refer to specific product and country guidelines). Child: In cases due to cystic fibrosis: Infants Initially, 2,000-5,000 units lipase/feeding.; <4 years Initially, 1,000 units lipase/kg/meal; ≥4 years Initially, 500 units lipase/kg/meal. All doses must be at a Max daily dose of 10,000 units lipase/kg/day. Dose is adjusted and individualised according to the needs, amount and type of food consumed, and dosage form. Dosage recommendations may vary among individual products and between countries (refer to specific product and country guidelines). Max Dosage: |
Special Precautions
Patient with hyperuricaemia, gout, pancreatic cancer. Renal impairment. Children. Pregnancy and lactation. Available brand products are not interchangeable. Some products contain pork protein. Patient Counselling May irritate oral mucosa; should not be held in mouth. Ensure adequate hydration. Monitoring Parameters Monitor nutritional intake, weight, faecal fat, stool character, growth (in children), and abdominal symptoms.
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Adverse Reactions
Significant: Fibrosing colonopathy, colonic strictures (in chronic high doses and mostly in paediatric patients with cystic fibrosis); severe hypersensitivity reactions (e.g. anaphylaxis, asthma, hives, pruritus); mucosal irritation, irritation of anus, risk of hyperuricaemia.
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhoea, constipation, abdominal distention, flatulence.
Skin and subcutaneous tissue disorders: Rash.
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Overdosage
Symptoms: Nausea, vomiting, abdominal pain, perianal irritation or inflammation, and hyperuricosuria and hyperuricaemia (at high doses). Management: Supportive treatment, ensure adequate hydration.
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Action
Pancreatin is a pancreatic enzyme containing lipases, proteases, and amylases derived from porcine pancreatic glands. It hydrolyses fats to glycerol, monoglyceride, and fatty acids, breaks down protein into peptides, proteoses, and derived substances, and converts starch into dextrins and short chain sugars (e.g. maltose, maltotriose) in the duodenum and proximal small intestine, much like the physiologic digestive enzyme produced by the pancreas.
Synonym(s): Pancrelipase.
Absorption: Not absorbed. Acts locally in the gastrointestinal tract. Excretion: Via faeces. |
Storage
Oral: Store below 25°C. Protect from moisture.
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CIMS Class
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