INFORMATION FOR HEALTH PROFESSIONALS
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PANCREASE Capsules are white, dye-free hard gelatin capsules containing a specially formulated Pancrelipase USP on enteric-coated beads . Capsules are imprinted with "0095" in red.
Pancrelipase is a porcine pancreatic enzyme concentrate predominantly steapsin (pancreatic lipase), amylase and protease. It is a cream-coloured, amorphous powder having a faint characteristic, but not offensive odour. Its activities are greatest in neutral or faintly alkaline media. It is inactivated in the presence of more than traces of mineral acids or large amounts of alkali hydroxides. An excess of alkali carbonate inhibits its action.
Each PANCREASE Capsule contains pancrelipase 193.8 mg average and not less than:
Lipase 5,600 BP Units Amylase 3,200 BP Units Protease 350 BP Units
Based on minimum potencies, Pancrelipase USP has about four times the protease activity, twelve times the lipase activity, and four times the amylase activity of Pancreatin USP, and equivalent protease activity, 1.5 times the lipase activity, and 0.6 times the amylase activity of Pancreatin BP.
Pancrelipase has actions and uses qualitatively similar to pancreatin. When administered orally it assists in the digestion of protein, carbohydrate, and fat.
The enzymes are present in the form of pH-sensitive enteric-coated microspheres which are filled into gelatin capsules. The microspheres, which are released from the capsule into the stomach, are enteric-coated to resist inactivation at low pH. Once released, the microspheres are distributed into the stomach and pass into the duodenum where, when the pH reaches 5.5, the enteric coating begins to dissolve and the enzymes are released. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, protein into proteoses and derived substances, and starch into dextrins and sugars. Controlled clinical studies in cystic fibrosis indicate that PANCREASE is effective in controlling steatorrhoea at low daily dose levels.
PANCREASE is indicated for patients with exocrine pancreatic enzyme deficiency as in:
Dosage is determined by the degree of steatorrhoea and the fat content of the diet. Start at a low dose and adjust based on 3-day faecal fat studies. If doses greater than 3,125 BP lipase units/kg/meal (5,000 BP lipase units/g fat/day) are required, other causes of malabsorption should be excluded. It is unknown whether doses above 3,125 BP lipase units/kg/meal are safe.
It is important to ensure that patients ingest a liberal amount of liquids to maintain adequate hydration while dosing with PANCREASE.
There is considerable variation among individual's response to enzymes with respect to control of steatorrhoea.
PANCREASE Capsules should only be taken with meals or snacks.
Whenever possible, PANCREASE Capsules should be swallowed intact with generous amounts of liquid. However, if swallowing of capsules is difficult, they may be opened and the microspheres sprinkled onto a small quantity of soft food on a teaspoon or tablespoon and ingested immediately.
It is advisable to choose foods which do not need to be chewed and have a pH lower than 7.3. Examples of such foods are apricot, banana, and sweet potato baby foods, applesauce, instant pudding and gelatin snacks. Contact of the micropheres with foods having a pH greater than 7.3 can dissolve the protective enteric coating and destroy enzyme activity.
To avoid irritation of the mouth, lips, and tongue, opened PANCREASE Capsules should be swallowed immediately before regular feedings or meals to minimize the likelihood that the microspheres are retained in the mouth. Proteolytic enzymes present in the formulation, when retained in the mouth, may begin to digest the mucous membranes and cause ulcerations.
PROTECT THE ENTERIC COATING, MICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED.
Recommended dosage - One or two capsules during each meal and one capsule with snacks. Higher doses may be required depending upon individual requirements.
The contents of one or two capsules may be taken with soft food that does not require chewing.
PANCREASE is contraindicated in patients with known hypersensitivity to pork proteins or any of the ingredients of this product. Hypersensitivity reactions to pork protein include sneezing, lachrymation and skin rashes.
PANCREASE is also contraindicated in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases.
Patients with pancreatic insufficiency should consume a high-calorie diet with unrestricted fat which is appropriate for age and clinical status. A nutritional assessment should be performed regularly as a component of routine care and additionally, when dosing of pancreatic enzyme replacement is altered.
It is important to ensure that patients ingest a liberal amount of liquids to maintain adequate hydration while dosing with PANCREASE.
Cases of fibrotic strictures in the colon have been reported 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. Patients currently on doses higher than 3,125 BP lipase units/kg/meal should be re-evaluated. (See Dosage and Administration section).
If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered. Any change in pancreatic enzyme replacement therapy (eg. 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 faecal fat excretion. (See Dosage and Administration section).
To protect the enteric coating, microspheres should not be crushed or chewed. Intact capsules should be swallowed with liquids at mealtime. If an intact capsule cannot be swallowed, it may be opened and the contents taken with small amounts of food that do not require chewing. (See Dosage and Administration section). If the microspheres come into extended contact with food for which the pH is higher than 7.3, then the protective enteric covering layer can dissolve.
The safe use of PANCREASE in pregnancy has not been established. Diethyl phthalate, an enteric coating component of PANCREASE Capsules has been reported with high intraperitoneal dosing to be teratogenic in rats. However, when this coating was administered orally to rats up to 100 times the human dose, no teratogenic or embryocidal effects were observed. Therefore, PANCREASE should not be used during pregnancy unless the potential benefits justify the potential risk to the foetus.
It is not known whether any of the components of PANCREASE are excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore, PANCREASE is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.
Clinical evidence indicates that PANCREASE Capsules are well tolerated.
The most frequently reported adverse events resulting from the post-marketing experience with pancreatic enzyme formulations are given below:
Common
| Gastrointestinal | diarrhoea, nausea, abdominal pain, flatulence, vomiting, constipation, melaena, perianal irritation, intestinal obstruction |
|---|---|
| General | weight decrease, pain |
Rare
| Gastrointestinal | fibrosing colonopathy in cystic fibrosis patients |
|---|---|
| Metabolic | hyperuricaemia and hyperuricosuria have been reported with the use of pancrelipase products, primarily with non-enteric coated formulations |
In patients with deficient pancreatic bicarbonate secretion, antacid supplementation may be required for control of steatorrhoea. It is important that any antacid supplementation should not be taken concomitantly with PANCREASE Capsules as the alkali may destroy the enteric coat.
Accidental or intentional ingestion of an overdose of PANCREASE has not been reported. However, the extremely high maximum tolerated dose in acute animal toxicity studies, reflects an extremely high therapeutic index. In mice, rats and dogs, an LD50 could not be determined because it was not possible to administer enough compound.
PANCREASE Capsules should be stored below 25°C in a dry place.
General Sale Medicine.
PANCREASE is available in bottles of 250 capsules.
PANCREASE Capsules contain povidone, sodium starch glycolate, sucrose spheres, cellulose acetate phthalate, diethyl phthalate, talc, maize starch, titanium dioxide, sodium chloride and gelatin. Each capsule contains not more than 19 mg sodium chloride equivalent to not more than 7.5 mg (0.32 mmol) sodium.
Janssen-Cilag Pty Ltd,
PO Box 9222,
Newmarket,
Auckland,
New Zealand
Tel: (09) 524 5012
Fax: (09) 523 1646
27 March 2001