Each enteric film-coated tablet contains 325 mg of Pancreatin BP that provides not less than the following enzymatic activity-
Amylase 7800 units
Protease 455 units
Lipase 6500 units
Pancreatin is a preparation of Pancreatin, an extract from mammalian pancreas containing enzymes with Amylase, Protease and Lipase activity. It is designed to disintegrate in the alkaline medium of the duodenum where it releases the active enzyme components of Pancreatin (Amylase, Protease and Lipase). Amylase hydrolyzes dietary starch to yield maltose, maltoriose and a-dextrin. Protease cleaves peptide bonds in the center of proteins and polypeptides and forms amino acids and oligopeptides. Lipase hydrolyzes dietary triglycerides forming two molecules of fatty acid and a molecule of beta-monoglyceride. It converts not less than 25 times its weight of starch into soluble carbohydrates and not less than 25 times its weight of casein into proteoses within 5 mins, (equivalent to 150 times in 30 mins).
2-3 tablets to be swallowed whole with little water immediately after or during meal. Or as directed by the physician
Alkaline media will rupture the enteric coating. As such to prevent bursting out of the content in the stomach Pancreatin should not be used concurrently with antacid.
Pancreatin is contraindicated in patients with known hypersensitivity to the drug.
The most frequent side effects are gastrointestinal including nausea, vomiting and abdominal discomfort. Buccal and perianal soreness may occur, particularly in infants. Hypersensitivity reactions manifested by sneezing, lacrimation or skin rashes have been reported.
Pancreatin should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pancreatin is administered to a nursing mother.
Patients known to be allergic to animal protein should be treated with caution.
Excessive dosage may produce a laxative effect. Systemic toxicity does not occur. Very high dosage may cause hyperuricaemia and hyperuricosuria