1. Clinical Overview
A standardized, porcine-derived pancreatic enzyme supplement combined with a bile salt. Pancreatin contains lipase, amylase, and protease enzymes to aid digestion of fats, carbohydrates, and proteins. Sodium Tauroglycocholate, a conjugated bile salt, emulsifies dietary fats, enhances lipase activity, and stimulates bile flow, providing a synergistic effect for comprehensive digestive support in exocrine pancreatic insufficiency (EPI).
| Onset | Duration | Bioavailability |
|---|---|---|
| 30 to 60 minutes post-ingestion. | 4 to 6 hours, corresponding to the postprandial digestive phase. | Enzymes act locally in the intestinal lumen; systemic absorption of active enzymes is negligible. Bile salts are absorbed via active transport in the terminal ileum with approximately 95% efficiency (enterohepatic circulation). |
2. Mechanism of Action
Pancreatin provides exogenous lipase, amylase, and protease to compensate for deficient endogenous pancreatic secretion. Lipase hydrolyzes triglycerides to monoglycerides and fatty acids. Amylase breaks down starch. Proteases cleave proteins into peptides and amino acids. Sodium Tauroglycocholate, a conjugated bile salt, reduces surface tension of fat globules, emulsifying them to increase surface area for lipase action. It also stimulates biliary and pancreatic secretion, enhances intestinal absorption of fats and fat-soluble vitamins (A, D, E, K), and may improve the dissolution of the enteric coating in the duodenum.
3. Indications & Uses
- Exocrine Pancreatic Insufficiency (EPI) due to Chronic Pancreatitis
- EPI due to Cystic Fibrosis (in conjunction with other care)
- EPI following Pancreatectomy or Gastrointestinal Bypass Surgery (e.g., Whipple's procedure)
4. Dosage & Administration
Adult Dosage: 1 to 2 capsules/tablets, swallowed whole with a full glass of water, at the beginning of each main meal (breakfast, lunch, dinner). Dosage must be individualized based on fat content of meal and severity of EPI. Typical range: 1-3 capsules per meal.
Administration: Swallow whole; do not crush, chew, or hold in mouth (can cause mucosal irritation). Take with meals or snacks. Do not take with antacids or proton pump inhibitors within 1-2 hours, as increased gastric pH may cause premature release of enzymes. Maintain adequate hydration.
5. Side Effects
Common side effects may include:
- Abdominal discomfort or cramping
- Nausea
- Flatulence
- Diarrhea or constipation
- Perianal irritation (with high doses)
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Acarbose, Miglitol | Pancreatin may reduce efficacy of these alpha-glucosidase inhibitors by digesting complex carbohydrates. | Moderate |
| Antacids (Calcium/Magnesium Carbonate), H2 Blockers, PPIs | May increase gastric pH, causing premature dissolution of enteric coating and inactivation of enzymes in stomach. | Moderate |
| Orlistat | Both are lipase inhibitors; concomitant use is contradictory and reduces efficacy of pancreatin. | Major |
| Iron Supplements, Folic Acid | Bile salts may enhance absorption of fat-soluble vitamins and possibly these nutrients. Monitor levels. | Minor |
| Bile Acid Sequestrants (Cholestyramine, Colestipol) | Bind to Sodium Tauroglycocholate, reducing its efficacy and potentially binding enzymes. Administer at least 2-4 hours apart. | Moderate |
7. Patient Counselling
- DO take the capsule/tablet at the start of every main meal and with snacks containing fat.
- DO swallow whole with plenty of water.
- DO NOT crush, chew, or break the tablet/capsule.
- DO NOT take the dose while lying down or just before bedtime.
- DO store in a cool, dry place away from moisture.
8. Toxicology & Storage
Overdose: Nausea, vomiting, severe abdominal cramping, diarrhea, perianal soreness. In children with cystic fibrosis, very high doses (exceeding 10,000 USP lipase/kg/meal) are associated with fibrosing colonopathy.
Storage: Store below 25°C, in a cool, dry place. Protect from moisture and direct sunlight. Keep the container tightly closed. Do not refrigerate unless specified by the manufacturer (condensation can damage enteric coating). Keep out of reach of children.