COMPOSITION Each regulated release capsule of enteric coated pancrelipase microspheres contains not less than:
Lipase 5 000 BP units
and/or 4 500 USP units
Amylase 2 900 BP units
and/or 20 000 USP units
Protease 330 BP units
and/or 25 000 USP units
PHARMACOLOGICAL CLASSIFICATION A.11.1 Medicines acting on the gastro-intestinal tract. Digestants.
PHARMACOLOGICAL ACTION The enteric-coated microspheres contained in PANKREASE resist gastric inactivation and deliver predictable, high levels of biologically active enzymes into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, protein into proteases and derived substances, and starch into dextrins and sugars.
INDICATIONS PANKREASE is indicated for the treatment of steatorrhoea secondary to exocrine pancreatic insufficiency in disorders such as:
CONTRA-INDICATIONS PANKREASE is contra-indicated in patients known to be hypersensitive to pork protein or any component of this product and in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases . Should hypersensitivity occur, discontinue medication and treat symptomatically. Pregnancy: The safety of PANKREASE in pregnancy has not been established.
WARNINGS: Cases of fibrotic strictures in the colon have been reported primarily in cystic fibrosis patients with the use of enzyme supplements. Some cases required surgery including resection of the bowel. If symptoms suggestive of gastro-intestinal obstruction occur, the possibility of bowel strictures should be considered and investigated.
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 DIRECTIONS FOR USE below.)
DOSAGE AND DIRECTIONS FOR USE Dosage should be individualised and determined by the degree of steatorrhoea and the fat content of the diet. Therapy should be initiated at the lowest possible dose and gradually increased until the desired control of steatorrhoea is obtained.
Infants (up to 12 months):
Fat-consumption scheme 2 000 - 4 000 USP lipase units per 120 mL of formula or per breast feeding. This provides approximately 450 - 900 lipase units per gram of fat ingested (based on 4,5 grams of fat per 120 mL standard cows milk-based infant formula).
Higher doses are used in infants because on average, infants ingest 5 grams of fat per kilogram of body weight per day whereas adults tend to ingest about 2 grams of fat per kilogram per day.
Children (over 12 months) and Adults:
Weight-based scheme: <4 years: Begin with 1 000 USP lipase units/kg/meal to a maximum of 2 500 lipase units/kg/meal.
>4 years: Begin with 400 USP lipase units/kg/meal to a maximum of 2 500 lipase units/kg/meal. If doses greater than 2 500 lipase units/kg/meal (4 000 lipase units per gram of fat per day) are required to control malabsorption, further investigation is warranted to rule out other causes of malabsorption. Doses greater than 2 500 lipase units/kg/meal should be used with caution and only if they are documented to be effective by 3-day fecal fat measures.
Colonic strictures, particularly in children, have been associated with doses above the recommended dosing range.
The daily dose of pancreatic enzyme supplement should not exceed 10 000 units of lipase activity per kilogram of body weight.
PANKREASE capsules should only be taken with meals or snacks. Whenever possible, PANKREASE capsules should be swallowed intact with generous amounts of liquid.
TO PROTECT ENTERIC COATING, MICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED.
Oral mucosal inflammation with contact bleeding has been reported.
Where swallowing of capsules is difficult, they may be opened and the microshperes shaken onto a small quantity of a 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 apricots, banana and sweet potato baby foods, applesauce, instant puddings and gelatin snacks. Contact of the microspheres 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 PANKREASE capsules should be swallowed immediately before regular feeding or meals to minimise the likelihood that the microspheres are retained in the mouth. Proteolytic enzymes present in the formulation, when retained in the mouth, may digest the mucous membranes and cause ulcerations.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS The most frequently reported side-effects resulting from the post-marketing experience with pancreatic enzyme formulations were gastro-intestinal and include diarrhoea, abdominal pain, intestinal obstruction, vomiting, flatulence, nausea, constipation melena and perianal irritation.
Frequently reported side-effects in other body systems include weight decrease and pain.
It should be noted that high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricaemia.
Cases of fibrosing colonopathy have been reported in cystic fibrosis patients. Folic acid status should be monitored and folic acid supplementation may have to be administered. Special Precautions No data are available on the effects of PANKREASE capsules on the ability to drive or to use machines. However, an effect is unlikely. Interaction 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.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT These have not been encountered.
Treatment is symptomatic and supportive.
IDENTIFICATION White opaque cap and body, hard gelatin capsule, imprinted "0095" in red on the body.
Capsules are filled with cream coloured beads.
PRESENTATION Round amber glass bottles fitted with a white screw cap, containing 100 capsules
Round polyethylene securitainers fitted with a polypropylene cap, containing 500 capsules.
STORAGE INSTRUCTIONS Keep bottle tightly closed and store in a dry place below 25°C. Do not refrigerate. Keep out of reach of children.
REGISTRATION NUMBER Q/11.1/86
NAME AND BUSINESS ADDRESS OF THE APPLICANT JANSSEN-CILAG logo
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
HALFWAY HOUSE, 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT 29 June 1999
Code No.: 024437
Updated on this site: March 2004
Source: Pharmaceutical Industry