Pancreatin is indicated for the treatment of:

• Exocrine pancreatic insufficiency due to cystic fibrosis
• Chronic pancreatitis
• Post-pancreatectomy or other related conditions

Pancreatin 10000 capsule contains: Pancreatin BP 150 mg equivalent to:

• Lipase 10000 Ph. Eur. Units
• Amylase 8000 Ph. Eur. Units
• Protease 600 Ph. Eur. Units

Pancreatin 25000 capsule contains: Pancreatin BP 300 mg equivalent to:

• Lipase 25000 Ph. Eur. Units
• Amylase 18000 Ph. Eur. Units
• Protease 1000 Ph. Eur. Units

Pancreatin contains pancreatic enzymes that catalyze the breakdown of fats into monoglycerides, glycerol, and free fatty acids; proteins into peptides and amino acids; and starches into dextrins and simple sugars such as maltose and maltotriose. These actions occur in the duodenum and proximal small intestine, where they function similarly to naturally secreted pancreatic digestive enzymes.

Infants (up to 12 months): Infants may be given 2,000 to 4,000 lipase units per 120 mL of formula or per breastfeeding. Do not mix pancreatin capsule contents directly into formula or breast milk prior to administration.

Children older than 12 months and younger than 4 years: Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 years and older and adults: Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Administration: Pancreatin is not interchangeable with any other pancrelipase product. Pancreatin should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be administered without crushing or chewing, followed by fluid to ensure complete ingestion.

No clinically significant drug interactions have been identified. No formal drug interaction studies have been conducted.

The most serious adverse reactions reported with pancreatic enzyme products containing pancrelipase include fibrosing colonopathy, hyperuricemia, and allergic reactions.

Pregnancy Category C. Animal reproduction studies have not been performed with pancrelipase. It is unknown whether it can cause fetal harm or affect reproductive capacity when used during pregnancy. The risk–benefit ratio should be considered when treating pregnant women with exocrine pancreatic insufficiency requiring enzyme therapy. Patients should inform their healthcare provider if they are pregnant or planning pregnancy during treatment.

It is not known whether pancrelipase is excreted in human breast milk. Breastfeeding patients should consult their healthcare provider.

Fibrosing colonopathy: A rare but serious condition reported with long-term, high-dose use of pancreatic enzyme products, most commonly in children with cystic fibrosis.

Oral mucosal irritation: Capsules should not be crushed, chewed, or mixed with food having pH >4, as this may destroy the enteric coating, cause enzyme release in the mouth, irritation, and loss of activity.

Risk of hyperuricemia: High doses may increase uric acid levels.

Potential viral exposure: The product is derived from porcine sources, carrying a theoretical risk.

Allergic reactions: May occur in sensitive individuals.

No overdose cases have been reported in clinical trials. However, long-term high doses have been associated with fibrosing colonopathy. High doses may also cause hyperuricosuria and hyperuricemia; caution is advised in patients with gout, renal impairment, or history of hyperuricemia.

Digestive Enzyme

Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.