Pancrelipase

What is pancrelipase?

• pancrelipase (PERTZYE ®) is a combination of porcine-derived lipases, proteases, and amylases used to reduce malabsorption when the pancreas is unable to secrete sufficient amounts of these enzymes.

What are the uses of this medicine?

• PERTZYE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.
• PERTZYE capsules contain a mixture of digestive enzymes including lipases, proteases and amylases from pig pancreas.

How does this medicine work?

• The pancreatic enzymes in PERTZYE catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No drug interactions have been identified. No formal interaction studies have been conducted.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage: ​ Infants (up to 12 months)

• Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or per breast feeding.
• Do not mix PERTZYE capsule contents directly into formula or breast milk prior to administration.

Children Older than 12 Months and Younger than 4 Years

• Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults

• Enzyme dosing should begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Administration:

• Take PERTZYE capsules exactly as your doctor tells you.
• You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor.
• Do not take more capsules in a day than the number your doctor tells you to take (total daily dose).
• Always take PERTZYE with a meal or snack and plenty of fluid. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose.
• Your doctor may change your dose based on the amount of fatty foods you eat or based on your weight.
• PERTZYE capsules should be swallowed whole. Do not crush or chew the PERTZYE capsules or their contents, and do not hold the capsule or capsule contents in your mouth. Crushing, chewing or holding the PERTZYE capsules in your mouth may cause irritation in your mouth or change the way PERTZYE works in your body.
• Throw away the PERTZYE capsule contents-food mixture that is not used. Do not save this mixture for later use.
• If you miss a dose of PERTZYE, wait until your next meal or snack and take your prescribed dose. Take your next dose at your usual time. Do not take two doses at one time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-Release Capsules: 4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase.
• Delayed-Release Capsules: 8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase.
• Delayed-Release Capsules: 16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase.
• Delayed-Release Capsules: 24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase

This medicine is available in fallowing brand namesː

• PERTZYE ®

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• upset stomach (indigestion)
• cough

PERTZYE may cause serious side effects, including:

• Irritation of the inside of your mouth
• Increase in blood uric acid levels
• Allergic reactions, including trouble swallowing or breathing, skin rash, itching, or swelling of your face, eyes, lips, tongue, or throat
• increase the risk of having a rare bowel disorder called fibrosing colonopathy

What special precautions should I follow?

• Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).
• To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth.
• Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.
• There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.
• Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• fibrosing colonopathy
• colonic strictures
• hyperuricosuria
• hyperuricemia
• gout
• renal impairment

Can this medicine be used in pregnancy?

• Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• PERTZYE is safe and effective in children when taken as prescribed by your doctor.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: lipase, protease and amylase
• Inactive Ingredients: sodium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc.

Who manufactures and distributes this medicine?

• Manufactured in the USA by:

Digestive Care, Inc. Bethlehem, PA

PERTZYE ® is a registered trademark of Digestive Care, Inc.

What should I know about storage and disposal of this medication?

• Store PERTZYE at room temperature 68ºF to 77ºF (20ºC to 25ºC).
• Keep PERTZYE in a dry place and in the original container or equivalent air tight container.
• After opening the bottle, keep it tightly closed between uses to keep your medicine dry (protect it from moisture).
• The PERTZYE bottle contains a desiccant packet to help keep your medicine dry. Do not eat or throw away the desiccant packet in your medicine bottle.

• Dailymed label info on Pancrelipase
• FDA Pancrelipase

Pancrelipase Resources
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