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Drug Details

PANCREASE

• Drug Class Description
  Pancreatic enzymes.
• Generic Name
  Pancreatin
• Presentation
  Size 0, elongated hard gelatin capsule, with a white opaque body and a white opaque cap, each ringed with a red band and the letters HL in red, containing enterically coated minitablets.
• Description
  Each capsule contains pancreatin, equivalent to 25000 units of lipase, 22500 units of amylase and 1250 units of protease.
• Indications
  

  Exocrine pancreatic enzyme deficiency as in cystic fibrosis, chronic pancreatitis, post pancreatectomy, post gastro-intestinal bypass surgery (eg Billroth II gastroenterostomy), and ductal obstruction from neoplasm (eg of the pancreas or common bile duct).

• Adult Dosage
  

  For oral administration.

  Patients with pancreatic insufficiency should undergo regular nutritional assessments as a component of routine care and additionally, when dosing of pancreatic enzyme replacement is altered.

  Dosage should be individualised to each patient, with therapy being initiated at the lowest possible dose and gradually increase until the desired control of steatorrhoea is obtained.

  Adults and children

  One or two capsules during each meal and one capsule with snacks. The interindividual response to pancreatin supplements is variable and the number of capsules may need to be titrated to the individual based upon parameters of steatorrhoea and symptomatology. Further dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

  Where patients are already in receipt of lower unit dose enteric coated pancreatin supplements, then Pancrease HL Capsules may be substituted at one-third of the number of capsules of the previous preparation.

  Where swallowing of capsules is difficult, then they may be opened and the minitablets taken with liquid or soft foods which do not require chewing. To protect the enteric coating, the minitablets should not be crushed or chewed.

  Contact of the minitablets with food having a pH higher than 5.0 can dissolve the protective coating and will reduce the efficacy of the product.

  It is important to ensure adequate hydration of patients at all times whilst dosing Pancrease HL Capsules.

  Patients who are taking or have been given in excess of 10,000 units of lipase/kg/day are at risk of developing colon damage. The dose of Pancrease HL should usually not exceed this dose.

• Child Dosage
  1 or 2 during each meal and 1 with snacks. A third capsule with meals may be taken if required; maximum 10,000 units/kg lipase daily. Pancrease HL is not recommended for cystic fibrosis in children under 15 years.
• Contra Indications
  

  Pancrease HL Capsules are contra-indicated in patients known to be hypersensitive to pork protein or any other component of this product.

  Children aged 15 or under with cystic fibrosis.

• Special Precautions
  

  Contact of the minitablets with food or liquid having a pH higher than 5.0 can dissolve the protective coating and will reduce efficacy of the product.

  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. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered. In some cases surgery including resection of the bowel is required and the need for this should also 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.

• Interactions
  Food with pH >7.5.
• Adverse Drug Reactions
  

  Postmarketing Experience

  Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Pancrelipase Capsules that meet threshold criteria are included in Table 1. The adverse drug reactions are ranked by frequency, using the following convention:

  Very common 1/10

  Common 1/100 and < 1/10

  Uncommon 1/1,000 and <1/100

  Rare 1/10,000 and <1/1,000

  Very rare <1/10,000, including isolated reports

  The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates that might be obtained in clinical trials or epidemiological studies.

  The most frequently reported adverse events were of gastrointestinal origin i.e. nausea, vomiting and diarrhoea.

  Table 1. Postmarketing reports of adverse drug reactions
  Metabolism and Nutrition Disorders
  Very rare	weight decrease
  Investigations
  Very rare	hyperuricosuria, hyperuricaemia
  Gastrointestinal disorders
  Very rare	abdominal distention, abdominal pain, abnormal faeces, colonic stenosis, diarrhoea, intestinal bleeding, perianal irritation, dyspepsia, fibrosing colonopathy, flatulence, ileal stenosis, intestinal obstruction, melaena, nausea, constipation, vomiting.
  General disorders and administration site conditions
  Very rare	oedema, pain,
  Skin and subcutaneous tissue disorders
  Very rare	pruritus, rash