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PANCREAZE 4200 UN DR CAP 100

  • Manufacturer Name : VIVUS
  • MFG # : 62541040210
  • NDC : 62541040210
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description S
Description -
Description S
DESI Drug Ind -; -
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category 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).
Drug Category S
Drug Category 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).
Drug Type Code COMMON BRAND NAME(S): Creon, Ultrase, Zenpep, Zymase
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Creon, Ultrase, Zenpep, Zymase
FDA Approval Date 04/12/2010
FDA Therap Equiv NR
HCPCS 1
HCPCS 1
HCPCS -
Market Entry Date 07/09/2010
Medical Coverage -
Medical Coverage 12/31/2022
Medical Coverage 12/31/2022
Termination Date (PAN-kree-LYE-pase)
Termination Date 12/31/2022
Termination Date (PAN-kree-LYE-pase)
Unit CAP
Units Per Pkg 1
Active Ingredients 1137 amylase 9000924; 1138 lipase 9001621; 1139 protease 9000991
Active Ingredients 1137 amylase 9000924; 1138 lipase 9001621; 1139 protease 9000991
Active Ingredients 1137 amylase 9000924; 1138 lipase 9001621; 1139 protease 9000991
AHFS Class 56160000 DIGESTANTS
AHFS Class 56160000 DIGESTANTS
AHFS Class 56160000 DIGESTANTS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form CAPSULE,DELAYED RELEASE (ENTERIC COATED)
Dose Form CAPSULE,DELAYED RELEASE (ENTERIC COATED)
Dose Form CAPSULE,DELAYED RELEASE (ENTERIC COATED)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 76628 lipase/protease/amylase ORAL CAPSULE DR 4.2K-14.2K
Gen Code and Des 76628 lipase/protease/amylase ORAL CAPSULE DR 4.2K-14.2K
Gen Code and Des 76628 lipase/protease/amylase ORAL CAPSULE DR 4.2K-14.2K
Inactive Ingredients 2537 povidone 9003398; 7543 sorbitan esters; 9277 pork derived (porcine)
Inactive Ingredients 2537 povidone 9003398; 7543 sorbitan esters; 9277 pork derived (porcine)
Inactive Ingredients 2537 povidone 9003398; 7543 sorbitan esters; 9277 pork derived (porcine)
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 4200UN DR
Strength 4200UN DR
Strength 4200UN DR
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Creon, Ultrase, Zenpep, Zymase
Common Brand Name -
Drug Interaction -
Drug Interaction 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 Interaction -
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 120
Case Quantity 120
Case Quantity 120
Drug Form Pack Size 100
Drug Form Pack Size 100
Drug Form Pack Size 100
Form CAPSULES
Form CAPSULES
Form CAPSULES
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 100
Unit Size 100
Unit Size 100
How to Use -
How to Use HOW TO USE: 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. 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. 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. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. 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.
How to Use -
Missed Dose 1
Missed Dose MISSED DOSE: 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.
Missed Dose 1
Notes CAP
Notes NOTES: Do not share this product with others.
Notes CAP
Overdose NR
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose NR
Phonetic Pronunciation -
Phonetic Pronunciation (PAN-kree-LYE-pase)
Phonetic Pronunciation -
Precautions -
Precautions PRECAUTIONS: Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas, gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage). If you have diabetes, pancrelipase may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions -
Side Effects -
Side Effects SIDE EFFECTS: Diarrhea, constipation, headache, abdominal pain/cramps/bloating, gas, cough, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects -
Storage 04/12/2010
Storage STORAGE: 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.
Storage 04/12/2010
Uses -
Uses 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).
Uses -

Frequently Asked Questions(FAQs)

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PANCREAZE 4200 UN DR CAP 100 is manufactured by VIVUS.
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