Monograph: |
PANCREATIN
CLINICAL PHARMACOLOGY
The outer layer of PANKREOFLAT 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.
INDICATIONS AND USAGE
PANKREOFLAT is indicated for the treatment of exocrine pancreatic insufficiency.
CONTRAINDICATIONS
PANKREOFLAT is contraindicated in patients with known hypersensitivity to the drug.
WARNINGS
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.
PRECAUTIONS
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 PANKREOFLAT. It is not known whether PANKREOFLAT can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PANKREOFLAT 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 PANKREOFLAT is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in children have not been established.
ADVERSE REACTIONS
Skin rash is the most frequently reported adverse reaction to PANKREOFLAT and appears to be associated with hypersensitivity to pork protein in the pancreatin. At high doses, a laxative effect may occur.
OVERDOSAGE
Excessive dosage may produce a laxative effect. Systemic toxicity does not occur.
DOSAGE AND ADMINISTRATION
Two tablets with each meal and 2 tablets taken with food eaten between meals or as directed by a physician. PANKREOFLAT tablets should be swallowed whole and not crushed or chewed.
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