Drugs List

Therapeutic Indications

Uses

Pancreatic enzyme deficiency

Administration

For oral administration.

The capsules should be swallowed whole with a glass of water.

Where swallowing of capsules is difficult, the capsules may be opened and the contents may be taken with fluid (preferably water) or small amount of soft food immediately after mixing. In order to protect the enteric coating, it is important that the contents are not to be crushed or chewed.

Avoid contact of the minitablets with food or liquid having a pH higher than 4.5 as it can dissolve the protective coating and reduce the efficacy of the product.

Contraindications

Cystic fibrosis in children aged 15 years and under

Precautions and Warnings

Children under 15 years
Breastfeeding
Gout
Hyperuricaemia
Pregnancy
Renal impairment

Maintain adequate hydration during therapy
Different brands may not be interchangeable
The product is of porcine origin
Avoid contact of powder with skin and mucous membranes
Monitor serum folate levels - add supplements if necessary
Review to exclude colonic damage in patients reporting abdominal symptoms
Advise patient to report bowel dysfunction immediately
Local irritation of mouth/anal area may occur - prevent with barrier cream
Cystic fibrosis: lipase dose should not usually exceed 10,000units/kg/day
Advise patients to avoid excessive heat when preparing mixture

Caution should be exercised when making any change in pancreatic enzyme replacement therapy.

Abdominal symptoms (those not usually experienced by the patient) or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10000 units of lipase per kg per day. Possible risk factors are gender (boys at greater risk than girls), more severe cystic fibrosis, and concomitant use of laxatives. The peak age for developing fibrosing colonopathy is between 2 and 8 years.

Stricture of the ileo-caecum and large bowel, and colitis have been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. In some cases surgery including resection of the bowel may be required.

Pregnancy and Lactation

Pregnancy

Pancreatin should be used with caution during pregnancy.

At the time of writing, there is no adequate data on the use of pancreatin in pregnant women.

Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected, but the potential risk to human pregnancy is still unknown.

The manufacturers advise that pancreatin should only be used during pregnancy where clearly necessary. They also recommend that if used, it should be given at doses that provide adequate nutritional status.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pancreatin should be used with caution during breastfeeding.

At the time of writing, there are no adequate data on the use of pancreatin during breastfeeding and it is not known whether pancreatin is excreted in breast milk. The manufacturer states that no effects on the suckling child are anticipated since animal studies show no systemic exposure of the breastfeeding woman to pancreatic enzymes. The manufacturers does however, recommend that pancreatin should only be used during breastfeeding if clearly necessary, and if administered, dose should be adequate to provide adequate nutritional status.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Buccal irritation
Colitis
Colonic stricture
Diarrhoea
Hyperuricaemia
Hyperuricosuria
Intestinal obstruction
Intestinal stricture
Nausea
Perianal irritation
Rash
Vomiting

Presentation

Capsule containing enteric coated mini tablets of pancreatin (lipase, amylase and protease).

Drugs List

Therapeutic Indications

Uses

Pancreatic enzyme deficiency

Dosage

Therapy should be initiated at the lowest possible dose and gradually increased until the desired control of steatorrhoea is obtained.

The interindividual response to pancreatin supplements is variable and the dosage may need to be titrated to the individual based on parameters of steatorrhoea and symptomatology. Further dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

Adults

Children

Additional Dosage Information

Administration

For oral administration.

The capsules should be swallowed whole with a glass of water.

Where swallowing of capsules is difficult, the capsules may be opened and the contents may be taken with fluid (preferably water) or small amount of soft food immediately after mixing. In order to protect the enteric coating, it is important that the contents are not to be crushed or chewed.

Avoid contact of the minitablets with food or liquid having a pH higher than 4.5 as it can dissolve the protective coating and reduce the efficacy of the product.

Contraindications

Cystic fibrosis in children aged 15 years and under

Precautions and Warnings

Children under 15 years
Breastfeeding
Gout
Hyperuricaemia
Pregnancy
Renal impairment

Maintain adequate hydration during therapy
Different brands may not be interchangeable
The product is of porcine origin
Avoid contact of powder with skin and mucous membranes
Monitor serum folate levels - add supplements if necessary
Review to exclude colonic damage in patients reporting abdominal symptoms
Advise patient to report bowel dysfunction immediately
Local irritation of mouth/anal area may occur - prevent with barrier cream
Cystic fibrosis: lipase dose should not usually exceed 10,000units/kg/day
Advise patients to avoid excessive heat when preparing mixture

Caution should be exercised when making any change in pancreatic enzyme replacement therapy.

Abdominal symptoms (those not usually experienced by the patient) or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10000 units of lipase per kg per day. Possible risk factors are gender (boys at greater risk than girls), more severe cystic fibrosis, and concomitant use of laxatives. The peak age for developing fibrosing colonopathy is between 2 and 8 years.

Stricture of the ileo-caecum and large bowel, and colitis have been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. In some cases surgery including resection of the bowel may be required.

Pregnancy and Lactation

Pregnancy

Pancreatin should be used with caution during pregnancy.

At the time of writing, there is no adequate data on the use of pancreatin in pregnant women.

Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected, but the potential risk to human pregnancy is still unknown.

The manufacturers advise that pancreatin should only be used during pregnancy where clearly necessary. They also recommend that if used, it should be given at doses that provide adequate nutritional status.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Pancreatin should be used with caution during breastfeeding.

At the time of writing, there are no adequate data on the use of pancreatin during breastfeeding and it is not known whether pancreatin is excreted in breast milk. The manufacturer states that no effects on the suckling child are anticipated since animal studies show no systemic exposure of the breastfeeding woman to pancreatic enzymes. The manufacturers does however, recommend that pancreatin should only be used during breastfeeding if clearly necessary, and if administered, dose should be adequate to provide adequate nutritional status.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Instruct patients not to increase dose on their own.

Side Effects

Abdominal distension
Abdominal pain
Buccal irritation
Colitis
Colonic stricture
Diarrhoea
Hyperuricaemia
Hyperuricosuria
Intestinal obstruction
Intestinal stricture
Nausea
Perianal irritation
Rash
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2014

Reference Sources

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Pancrease HL capsules. Janssen-Cilag Ltd. Revised October 2013.

Summary of Product Characteristics: Nutrizym 22. Merck Serono Ltd. Revised September 2014.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017