Each enteric-coated tablet contains 116mg of Pancreatin (Pancreas Powder) equivalent to: Amylase activity 4,200 Ph. Eur. units, Lipase activity 3,500 Ph. Eur. units, Protease activity 250 Ph. Eur. units.
Enzystal P is a combination of three enzymes: lipase, protease and amylase. These three enzymes are produced naturally in the pancreas and are important in the digestion of fats, proteins and sugars.
Eynzystal P is used to replace these enzymes when the body does not have enough of its own. Conditions for which pancrelipase may be used include cystic fibrosis, chronic inflammation of the pancreas, and blockage of the pancreatic ducts. In addition, Enzystal P may be used following removal of pancreas.
Pharmacology: Pharmacodynamics: Pancreatin is derived from porcine pancreas and contains the enzymes amylase, protease and lipase. The enzymes have the same actions as pancreatic juice and when administered to patients with pancreatic insufficiency to improve the ability to metabolize starches, proteins and fats.
Pharmacokinetics: Pancreatin hydrolyzes fats to glycerol and fatty acids, changes proteins into proteases and derived substances, and converts starch into dextrins and sugars.
Pancreatin is used to compensate for reduced intestinal enzyme activity in pancreatic deficiency states. It is indicated for the treatment of fibrocystic disease of the pancreas (cystic fibrosis), chronic pancreatitis, and pancreatic steatorrhea following pancreatectomy. As an aid to digestion following gastrectomy.
Dosage should be adjusted to individual needs and depends on the severity of the disease and the composition of food consumed.
The following dosage ranges provide a suitable basis for adjustment.
Infants: the contents of 1-2 tablets mixed with food.
Older Children and Adults: the contents of 2-6 tablets with each snack or meal. The tablets may be swallowed.
The tablets may provide a suitable alternative to the enteric-coated presentations in cases where the pH of the duodenum is not sufficiently alkaline to dissolve the enteric coat.
It is important to ensure adequate hydration at all times, especially during periods on increased loss of fluids. Inadequate hydration may aggravate constipation.
If the tablet is mixed with liquids or food, the resulting mixture should be used immediately and should not be stored for more than one hour prior to use.
Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricemia.
Hypersensitivity to the active ingredients or any of the excipients.
Allergic reactions mainly but not exclusively limited to the skin have been observed when taking pancreatin tablets. Unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units/kg/day of lipase.
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 of developmental toxicity is to be expected.
Caution should be exercised when prescribing to pregnant women.
Pancreatic enzymes can be used during breastfeeding.
Pancreatin should be used in doses sufficient to provide adequate nutritional status.
The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild to moderate in severity. Strictures of the ileo-caecum and large bowels have been reported in patients with cystic fibrosis taking high doses of pancreatic enzyme supplements.
Allergic reactions mainly but not exclusively limited to the skin have been reported.
No reported drug interactions are known.
Store at temperatures not exceeding 30°c.
A09AA - Enzyme preparations ; Used as digestives.
Enzystal P EC tab 116 mg
20's (P400/box)
Sign Out
