Donnazyme tablets are available for oral administration.
Each tablet contains:
|
Pancreatin, USP equivalent ........................................ 500 mg which provides not less than the following enzymatic activity-- Lipase ........................................................ 1,000 USP Units Protease ................................................... 12,500 USP Units Amylase ................................................... 12,500 USP Units |
Inactive Ingredients: Acacia, Acetylated Monoglycerides, Calcium Sulfate, Carnauba Wax, Cellulose Acetate Phthalate, Corn Starch, D&C Yellow 10 Aluminum Lake, Diethyl Phthalate, Edible Ink, FD&C Blue 1 Aluminum Lake, FD&C Yellow 6 Aluminum Lake, Gelatin, Methylparaben, Microcrystalline Cellulose, Polysorbates, Povidone, Propylparaben, Shellac, Sodium Benzoate, Stearic Acid, Sucrose, Titanium Dioxide, Wheat Flour, White Wax. May contain Docusate Sodium.
The outer layer of Donnazyme tablets is gastric-soluble.
The core of the tablet contains pancreatin. It is designed to disintegrate in the alkaline medium of the duodenum where it releases the active enzyme components of pancreatin (trypsin, amylase and lipase). Trypsin breaks down larger protein fractions into peptides; amylase converts starch into maltose; lipase splits fat into fatty acids and glycerin.
Donnazyme is indicated for the treatment of exocrine pancreatic insufficiency.
Donnazyme is contraindicated in patients with known hypersensitivity to the drug.
Do not take this product if you are allergic to pork.
Do not take this product unless directed by a physician.
Do not exceed the labeled dose unless directed by a physician.
Do not chew tablets.
Swallow tablets quickly to lessen potential for mouth irritation.
Carcinogenesis, mutagenesis: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy Category C. Animal reproduction studies have not been conducted with Donnazyme. It is not known whether Donnazyme can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnazyme should be given to a pregnant woman only if clearly needed.
Nursing mothers: 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 Donnazyme is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in children have not been established.
Skin rash is the most frequently reported adverse reaction to Donnazyme and appears to be associated with hypersensitivity to pork protein in the pancreatin. At high doses, a laxative effect may occur.
Excessive dosage may produce a laxative effect. Systemic toxicity does not occur.
Two tablets with each meal and 2 tablets taken with food eaten between meals or as directed by a physician. Donnazyme tablets should be swallowed whole and not crushed or chewed.
Kelly green tablets in bottles of 100 (NDC 0031-4650-63). Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). Dispense in tight container.
Manufactured by:
Pharamaceutical Division
A.H. Robins Company
Richmond, VA 23220
rev. 2/95
|
|