Amylase; Cellulase; Lipase; Protease
LIPASE
Indications: Dyspepsia
DESCRIPTION:
CLINICAL PHARMACOLOGY:
Diminution of secretions from exocrine glands is often a result of the normal aging process. Amylase; cellulase; lipase; protease provides a balanced combination of natural proteolytic, amylolytic, cellulolytic and lipolytic enzymes to enhance digestion of proteins, starch and fat in the gastrointestinal tract. These enzymes do not exert any systemic pharmacologic effects. Amylase; cellulase; lipase; protease should be considered an enzyme supplement and not an enzyme replacement therapy. Enzymes in amylase; cellulase; lipase; protease are basically derived from fungal and plant sources and possess a broad spectrum of pH activity. Enzymes are promptly released from the capsules and are bioavailable for digestion of food in the stomach and intestines.
INDICATIONS AND USAGE:
For the relief of functional indigestion when due to enzyme deficiency or imbalance. Amylase; cellulase; lipase; protease relieves symptoms due to faulty digestion including the sensation of fullness after meals, dyspepsia, flatulence, abdominal distention and intolerance to certain foods.
PANCREASE is indicated for the treatment of steatorrhea secondary to pancreatic insufficiency such as cystic fibrosis or chronic alcoholic pancreatitis.
CONTRAINDICATIONS
PANCREASE Capsules are contraindicated in patients known to be hypersensitive to pork protein or any other component of this product.
WARNINGS
Cases of fibrotic strictures in the colon have been reportedly primarily in cystic fibrosis patients with the use of enzyme supplements, generally at dosages above the recommended range. Some cases required surgery including resection of the bowel. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered.
Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision. It is recommended that therapy be initiated at a low dose, followed by titration to an effective dose. The titration schedule should be guided by measured changes in 3-day fecal fat excretion. (See DOSAGE AND ADMINISTRATION .)
CONTRAINDICATIONS:
Amylase, cellulase, lipase, and protease capsules are contraindicated in patients known to be hypersensitive to pork protein and in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases.
WARNINGS:
Do not administer to patients who are allergic to pork products. Should hypersensitivity occur, discontinue medication and treat symptomatically.
PRECAUTIONS:
Information for the Patient: If capsules are opened, avoid inhalation of the powder. Sensitive individuals may experience allergic reactions.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of amylase; cellulase; lipase; protease.
Pregnancy Category C :It is also not known whether amylase; cellulase; lipase; protease can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Amylase; cellulase; lipase; protease should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether amylase; cellulase; lipase; protease is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when amylase; cellulase; lipase; protease is administered to a nursing woman.
Reproduction studies have been conducted in rats and rabbits at doses 0.44 times and 0.35 times the maximum daily human dose, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to PANCREASE. No fertility or peri-/postnatal studies have been performed in animals. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Pancreatic enzymes act locally in the gastrointestinal tract and are not likely to be systematically absorbed. Some of the constituent amino and nucleic acids are likely to be absorbed along with dietary proteins. The possibility of the protein constituents appearing in the breast milk can not be excluded.
Pediatric Use
Colonic strictures, particularly in children with cystic fibrosis, have been associated with doses generally above the recommended dosing range (See WARNINGS .) Patients currently receiving doses >2,500 lipase units/kg/meal or 4,000 lipase units/gm fat/day should be re-evaluated and the dosage either immediately decreased or titrated downward to the lowest effective clinical dose as assessed by 3-day fecal fat excretion.
Geriatric Use
Studies on the relationship of age to the effects of pancrelipase have not been conducted. However, geriatric-specific problems that would limit the usefulness of this medication in the elderly are not expected.
ADVERSE REACTIONS:
Virtually unknown. Occasionally a slight looseness of stools may be noticed. If so, dosage should be reduced. Finely powdered pancreatic enzyme may be irritating to the mucous membranes and respiratory tract. Inhalation of the airborne powder may precipitate an asthma attack in sensitive individuals.
The most frequently reported adverse events resulting from the post-marketing experience with PANCREASE were gastrointestinal and include diarrhea, abdominal pain, intestinal obstruction, vomiting, flatulence, nausea, constipation, melena, and perianal irritation. Frequently reported adverse events in other body systems included weight decrease and pain. Hyperuricemia and hyperuricosuria have been reported with the use of pancrelipase products, primarily with non-enteric coaated formulations. Cases of fibrosing colonopathy have been reported primarily in cystic fibrosis. (See WARNINGS )
OVERDOSAGE:
No systemic toxicity occurs. Excessive dosage may, however, produce a laxative effect.