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Pertzye 8000 USP units Capsule
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Indications & Clinical Uses
- Pertzye 8000 USP units is a brand of pancrelipase, a pancreatic enzyme replacement therapy containing lipase, protease and amylase, supplied as delayed-release capsules in four strengths (4,000, 8,000, 16,000 and 24,000 USP lipase units).
- It is approved by the US FDA (initial approval 2012) to treat exocrine pancreatic insufficiency (EPI) - inadequate digestive enzyme production - due to cystic fibrosis or other conditions such as chronic pancreatitis or pancreatectomy, in adults and pediatric patients including infants.
- Capsules are taken with meals and snacks to help digest fat, protein and starch.
- Pertzye is a self-administered oral medicine, not hospital-only, and is taken throughout life for as long as enzyme deficiency persists.
Side Effects
- The most common side effects, each reported in 10% or more of patients, are diarrhea, dyspepsia (indigestion) and cough; abdominal pain, flatulence, constipation, nausea and blurred vision have also been reported.
- A rare but serious risk is fibrosing colonopathy, a narrowing of the bowel wall linked to very high enzyme doses, seen mostly in children with cystic fibrosis; report new or worsening abdominal pain, distension, or reduced bowel movements promptly.
- Because Pertzye is derived from pig pancreas, hypersensitivity reactions are possible in people with pork protein allergy.
- Pertzye's current US label carries no boxed warning.
- Seek urgent medical help for signs of a severe allergic reaction, such as swelling, rash or difficulty breathing.
Precautions & Warnings
- Do not crush or chew Pertzye capsules; they must be swallowed whole, or opened and the contents sprinkled on a small amount of acidic soft food (pH 4.5 or below, such as applesauce) and swallowed immediately without chewing - do not mix into an entire meal, infant formula or breast milk, or into alkaline food.
- Avoid exceeding recommended lipase-unit limits per kilogram of bodyweight per meal, particularly in children under 12 with cystic fibrosis, because of the fibrosing colonopathy risk.
- Use with caution in people with gout, kidney impairment or elevated uric acid, since pancreatic enzymes can raise blood uric acid levels.
- Pertzye is for oral use only.
- Discuss use during pregnancy or breastfeeding, and any pork-product allergy, with your healthcare provider before starting.
Avoid Interactions
- No formal drug-interaction studies have been conducted with Pertzye, and its enzyme components are not absorbed systemically or metabolised by CYP enzymes, so no clinically significant drug-drug interactions are expected.
- There are no specific foods or drinks to avoid other than the requirement to take Pertzye only with acidic soft food if capsules are opened, since alkaline conditions can destroy the enzyme coating before it reaches the small intestine.
- Tell your healthcare provider and pharmacist about all other medicines, supplements and other pancreatic enzyme products you use, so your overall enzyme dosing can be reviewed and duplication avoided.
References
Frequently Asked Questions
Pertzye (pancrelipase) replaces digestive enzymes in people whose pancreas cannot make enough, a condition called exocrine pancreatic insufficiency. It is used in cystic fibrosis, chronic pancreatitis and after pancreas surgery, in both adults and children.
Pertzye capsules are swallowed whole with every meal and snack. If a child cannot swallow capsules, they can be opened and sprinkled on a small spoon of acidic soft food like applesauce and swallowed right away without chewing - never crush or chew the capsule itself.
The most common side effects of Pertzye are diarrhea, indigestion and cough. Rarely, very high doses can cause fibrosing colonopathy, a bowel narrowing seen mainly in children with cystic fibrosis - report new stomach pain, bloating or fewer bowel movements to your provider.
Avoid crushing or chewing Pertzye capsules, and avoid mixing the contents into a whole meal, infant formula, breast milk or alkaline food if you open them. Do not exceed the lipase dose your provider prescribes per meal, since very high doses raise colon risks.
If you miss a dose of Pertzye, just take the next dose with your next meal or snack as usual - do not double up. Pertzye only works when taken with food, so a missed dose eaten without enzymes simply means that meal was not digested as well.
Yes, Pertzye (pancrelipase) is approved for infants, children and adults with exocrine pancreatic insufficiency. Pediatric cystic fibrosis patients need careful dose limits per kilogram of bodyweight to avoid the rare bowel complication fibrosing colonopathy.
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