Zymase® capsules contain enteric coated spheres of pancrelipase, a substance containing enzymes, principally lipase, with amylase and protease obtained from the pancreas of the hog. Each capsule contains not less than:
Lipase--12,000 USP Units
Protease--24,000 USP Units
Amylase--24,000 USP Units
Each capsule also contains: Gelatin, purified water, starch, talc, titanium dioxide, FD&C Green #3, FD&C Yellow #10, and other inactive ingredients.
Zymase® is protected against inactivation by gastric acidity, and active enzymes are released in the duodenum. The enzymes promote hydrolysis of fats into glycerol and fatty acids, protein into proteases and derived substances, and starch into dextrans and sugars.
Zymase® is indicated in conditions where pancreatic enzymes are either absent or deficient with resultant inadequate fat digestion. Such conditions include but are not limited to chronic pancreatitis, pancreatectomy, cystic fibrosis and steatorrhea of diverse etiologies.
Known hypersensitivity to pork protein.
To maintain enteric coating integrity, do not chew or crush spheres.
No adverse reactions have been reported. It should be noted, however, that extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricemia.
One to two capsules with each meal or snack. Individual cases may require higher dosage and dietary adjustment. Where swallowing of capsules is difficult, capsules may be opened and the spheres taken with liquids or soft foods which do not require chewing.
Not to exceed 25°C (77°F). Store in dry place when opened.
In tight container as defined in the USP.
Bottles of 100, NDC 0052-0393-91
5308530 393 91 5/99 04
Revised 4/93
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