1. Clinical Overview
A fixed-dose combination of digestive enzymes and an antiflatulent. Pancreatin, a porcine-derived enzyme mixture containing amylase, lipase, and protease, aids in the digestion of carbohydrates, fats, and proteins. Dimethicone is a silicone-based polymer that reduces gas-related discomfort by lowering surface tension of gas bubbles, causing them to coalesce and be expelled more easily. This combination is widely used in India for symptomatic relief of dyspepsia, bloating, and flatulence associated with pancreatic insufficiency and functional gastrointestinal disorders.
| Onset | Duration | Bioavailability |
|---|---|---|
| Pancreatin: 30-60 minutes post-ingestion. Dimethicone: 15-30 minutes. | Pancreatin: 3-4 hours. Dimethicone: 2-3 hours. | Pancreatin: Enzymes are not systemically absorbed; act locally in the GI lumen. Dimethicone: Not absorbed; acts topically on gas bubbles. |
2. Mechanism of Action
Pancreatin provides exogenous lipase, amylase, and protease to compensate for deficient endogenous pancreatic secretion, facilitating the hydrolysis of fats into fatty acids and glycerol, starches into dextrins and sugars, and proteins into proteoses and derived substances. Dimethicone is a surfactant with defoaming properties. It reduces the surface tension of gas bubbles trapped in the gastrointestinal mucus and content, causing them to coalesce. The larger bubbles are easier to expel via belching or flatus, relieving sensations of pressure, bloating, and discomfort.
3. Indications & Uses
- Symptomatic relief of flatulence, bloating, and abdominal discomfort
- Pancreatic exocrine insufficiency (e.g., due to chronic pancreatitis, cystic fibrosis, post-pancreatectomy)
- Functional dyspepsia with gas-related symptoms
4. Dosage & Administration
Adult Dosage: One to two tablets/capsules, three times daily with meals or as directed by the physician. The dose should be taken during or immediately after meals.
Administration: Swallow the tablet/capsule whole with a full glass of water. Do NOT crush, chew, or break enteric-coated formulations. Take during or immediately after meals to coincide with the presence of food in the stomach and duodenum. Do not lie down immediately after taking the dose.
5. Side Effects
Common side effects may include:
- Nausea
- Abdominal cramping/discomfort
- Diarrhea or loose stools (especially with high doses)
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Acarbose, Miglitol | Pancreatin may reduce the efficacy of these alpha-glucosidase inhibitors by digesting carbohydrates. | Moderate |
| Antacids containing Calcium Carbonate or Magnesium Hydroxide | May reduce the efficacy of enteric-coated pancreatin by raising gastric pH and causing premature release of enzymes. | Moderate |
| Iron Supplements (e.g., Ferrous Sulfate) | Pancreatin may impair iron absorption. Separate administration by at least 2 hours. | Moderate |
| Folic Acid | Pancreatin may reduce folic acid absorption. Monitor levels with long-term use. | Moderate |
| Orlistat | Additive effect on fat malabsorption and steatorrhea; increased risk of GI side effects. | Moderate |
7. Patient Counselling
- DO take the tablet/capsule during or immediately after meals.
- DO swallow the tablet whole with plenty of water.
- DO inform your doctor if you are allergic to pork.
- DO NOT crush, chew, or break the tablet, especially if it is enteric-coated.
- DO NOT take the medication on an empty stomach.
- DO NOT lie down for at least 10 minutes after taking the dose.
8. Toxicology & Storage
Overdose: Symptoms are primarily gastrointestinal: severe nausea, vomiting, diarrhea, abdominal cramps, and perianal irritation. Hyperuricemia may occur with massive, chronic overdose.
Storage: Store in a cool, dry place, below 25°C. Protect from moisture and direct sunlight. Keep out of reach of children. Do not use after the expiry date printed on the pack.