Zenpep: Uses, Side Effects & Dosage | Healio

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Zenpep

Brand Names

Creon, Ultrase, Zenpep, Zymase

Generic Name

amylase

Phonetic Name

(PAN-kree-LYE-pase)

Clinical Uses

This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (conditions such as chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

Dosage and Administration

Preparations

• 4000 units Brand(s): USP Pancrecarb(R) MS-4 (with units Lipase enteric-coated microspheres), activity, with Digestive Care 25,000 USP units Amylase activity, and 25,000 USP units Protease activity 4500 USP units Lipram(R) 4500 (enteric-coated Lipase microspheres), Global activity, 20,000 USP units Amylase activity, and 25,000 USP units Protease activity Pancrease(R) (enteric-coated microspheres), Ortho-McNeil Pangestyme(R), Ethex Ultrase(R) (enteric-coated microspheres), Axcan Scandipharm 5000 USP units Creon(R) 5 Minimicrospheres(R) Lipase (enteric-coated microspheres), activity, with Abbott 16,600 USP units Amylase activity, and 18,750 USP units Protease activity Lipram(R)-CR5 (enteric-coated microspheres), Global 8000 USP units Pancrecarb(R) MS-8 Lipase (enteric-coated microspheres), activity, with Digestive Care 40,000 USP units Amylase activity, and 45,000 USP units Protease activity 10,000 USP Lipram(R)-PN10 (enteric-coated units Lipase microspheres), Global activity, 30,000 USP units Amylase activity, and 30,000 USP units Protease activity Pancrease(R) MT 10 (enteric-coated microtablets), Ortho-McNeil 10,000 USP Creon(R)
• 10 units Brand(s): Lipase Minimicrospheres(R) activity, with (enteric-coated microspheres), 33,200 USP Abbott units Amylase activity, and 37,500 USP units Protease activity Lipram(R)-CR10 (enteric-coated microspheres), Global Pangestyme(R) CN 10, Ethex 12,000 USP Lipram(R)-UL12 (enteric-coated units Lipase microspheres), Global activity, with 39,000 USP units Amylase activity, and 39,000 USP units Protease activity Pangestyme(R) UL 12, Ethex Ultrase(R) MT12 (enteric-coated minitablets), Axcan Scandipharm 16,000 USP Lipram(R)-PN16 (enteric-coated units Lipase microspheres), Global activity, 48,000 USP units Amylase activity, and 48,000 USP units Protease activity Pancrease(R) MT 16 (enteric-coated microtablets), Ortho-McNeil Pangestyme(R) MT 16, Ethex 16
• 000 units Brand(s): Pancrecarb(R) MS-16 USP units (enteric-coated microspheres), Lipase Digestive Care activity, with 52,000 USP units Amylase activity, and 52,000 USP units Protease activity 18,000 USP Lipram(R)-UL18 (enteric-coated units Lipase microshperes), Global activity, with 58,500 USP units Amylase activity, and 58,500 USP units Protease activity Pangestyme(R) UL 18, Ethex Ultrase(R) MT18 (enteric-coated minitablets), Axcan Scandipharm 20,000 USP Lipram(R)-PN20 (enteric-coated units Lipase microspheres), Global activity, with 56,600 USP units Amylase activity, and 44,000 USP units Protease activity Pancrease(R) MT 20 (enteric-coated microtablets), Ortho-McNeil 20,000 USP Lipram(R)-UL20 (enteric-coated units Lipase microspheres), Global activity, with 65,000 USP units Amylase activity, and 65,000 USP units Protease activity Pangestyme(R) UL 20, Ethex Ultrase(R) MT20 (enteric-coated minitablets), Axcan Scandipharm 20,000 USP Creon(R)
• 20 units Brand(s): lipase Minimicrospheres(R) activity, with (enteric-coated microspheres), 66,400 USP Abbott units Amylase activity, and 75,000 USP units Protease activity Lipram(R)-CR20 (enteric-coated microspheres), Global Pangestyme(R) CN 20, Ethex Powder 16,800 USP Viokase(R), Axcan Scandipharm units Lipase activity per
• 0.7 g Brand(s): , 70,000 USP units Amylase activity per
• 0.7 g Brand(s): , and 70,000 USP units Protease activity per
• 0.7 g Brand(s): Tablets 8000 USP units Pancrelipase Tablets, Global Lipase activity, 30,000 USP units Amylase activity, and 30,000 USP units Protease activity Panokase(R), Breckenridge Viokase(R) 8, Axcan Scandipharm 16,000 USP Pancrelipase Tablets, Global units Lipase activity, with 60,000 USP units Amylase activity, and 60,000 USP units Protease activity Panokase(R) 16, Breckenridge Viokase(R) 16, Axcan Scandipharm

Administration Notes

Some brands of this medication have a Medication Guide provided by your pharmacist. If one is available, read the Medication Guide before your start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with meals and snacks as directed by your doctor. Swallow the capsule whole. Do not crush or chew the capsules or keep the capsules in your mouth. Doing so can irritate the mouth and also change the way the medication works. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. If swallowing is difficult, then the capsule may be opened and the contents mixed in a small amount of liquid or soft food that does not need to be chewed (such as room-temperature applesauce). Do not mix the contents of the capsule with alkaline food or liquid (such as milk, ice cream, tea). Consult your doctor or pharmacist for more information about what foods/liquids (such as infant formula, breast milk) to avoid when mixing. Swallow the food or liquid right away, making sure not to chew the medication. Drink a glass of water or juice after swallowing the food to make sure all the medication is swallowed. Do not save the medication mixture for later. The dosage is based on your medical condition, diet, weight, and response to treatment. Do not take more capsules in a day than prescribed by your doctor. Your condition will not improve any faster, and your risk of side effects will increase. Use this medication regularly to get the most benefit from it. Take it with every meal or snack. If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication. Do not change brands or dosage forms of pancrelipase without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes. Tell your doctor if your condition lasts or gets worse.

Missed Dose Instructions

If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

Label Warnings

Take with food. Do not chew or crush before swallowing. May sprinkle capsule contents on unheated applesauce. Swallow mixture immediately without chewing. Warning: To prevent loss of effect, keep drug in original container. Close tightly right away after each use. Medication should be taken with plenty of water.

Indications

• exocrine pancreatic insufficiency

This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (conditions such as chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

Contraindications

• gastrointestinal obstruction
• meconium ileus

• Crohn's disease
• fibrosing colonopathy
• gastrointestinal tract surgery
• gout
• hyperuricemia
• short bowel syndrome

Common Adverse Effects

• Abdominal distension
• Cough
• Dizziness
• Flatulence
• Headache disorder

• Pruritus ani
• Pruritus of skin
• Skin rash
• Urticaria

Serious Adverse Effects

• Abdominal pain with cramps

• Biliary calculus
• Diarrhea
• Disorder of the digestive system
• Fibrosing colonopathy
• Gastrointestinal obstruction
• Hyperuricemia
• Nausea

Elderly Precautions

Pregnancy Precautions

PrecautionSeverityNarrativePROTEASERequires a Risk/Benefit AssessmentAvailable human data show no increased risk for major birth defects. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes. Insufficient animal data available.LIPASEFDA C (unknown human fetal risk; assess risk/benefit)Limited human data available. Systemic drug absorption is negligible after oral administration.AMYLASEFDA C (unknown human fetal risk; assess risk/benefit)Limited human data available. Systemic drug absorption is negligible after oral administration.

Lactation Precautions

SeverityNarrativePrecautionINSUFF DATA AVAIL;CONSIDER MATERNAL TREATMENT BENEFIT VS POSSIBLE INFANT RISKPrecautionINSUFFICIENT HUMAN DATA AVAILABLEPrecautionINSUFFICIENT HUMAN DATA AVAILABLE

Pediatric Precautions

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: acarbose, miglitol.

Drug Interactions Table

Chemical Properties

Pancrelipase is a substance containing enzymes, principally lipase, with amylase and protease, obtained from the pancreas of the hog, Sus scrofa Linne var. domesticus Gray (Fam. Suidae). Pancrelipase meets standards established by USP. One USP unit of lipase activity is contained in the amount of pancrelipase that liberates 1 mcEq of acid per minute at pH 9 and 37degreesC under conditions of the USP assay. One USP unit of amylase activity is contained in the amount of pancrelipase that decomposes starch at an initial rate such that 1 mcEq of glucosidic linkage is hydrolyzed per minute under the conditions of the USP assay. One USP unit of protease activity is contained in the amount of pancrelipase that digests 1 mg of casein under the conditions of the USP assay. Each mg of pancrelipase contains not less than 24 USP units of lipase activity, not less than 100 USP units of amylase activity, and not less than 100 USP units of protease activity. On a weight basis, pancrelipase has 12 times the lipolytic activity of pancreatin (no longer commercially available in the US); the trypsin and amylase content of pancrelipase is at least 4 times that of pancreatin.

Stability Information

Pancrelipase is inactivated by acids present in more than trace amounts. Pancrelipase, in common with other pancreatic enzyme preparations, is partially inactivated by gastric juice in vivo. Pancrease(R) and Pancrease(R) MT delayed-release capsules containing enteric-coated microspheres and enteric-coated microtablets of the drug, respectively, are designed to disintegrate at pH greater than 6. Pancrecarb(R) delayed-release capsules containing enteric-coated microspheres release their enzymes at approximately pH 5.5. Ku-Zyme(R) HP preparations should be stored in tight containers at a temperature not exceeding 25degreesC; opened containers of these preparations should be stored in a dry place, and a desiccant may be useful. Pancrease(R), Pancrease(R) MT, and Pancrecarb(R) delayed-release capsules should be stored in a dry place in tightly closed containers at 15-25degreesC; opened containers of these preparations should not be refrigerated. Creon(R) delayed-release capsules should be stored in tight, light-resistant containers at 25degreesC, but may be exposed to temperatures ranging from 15-30degreesC; Creon(R) capsules should not be refrigerated. Viokase(R) preparations should be stored in a dry place in tight containers at a temperature not exceeding 25degreesC.

Storage Requirements

Store at room temperature away from light and moisture. Check the product package for more details on how to store your brand, or ask your pharmacist. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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