Pancrelipase (Ultrase)
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Pancrelipase (Ultrase)

ULTRASE®
(pancrelipase) Capsules Enteric-Coated Microspheres

DRUG DESCRIPTION

ULTRASE® (pancrelipase) Capsules are orally administered and contain 250 mg of enteric-coated microspheres of porcine pancreatic enzyme concentrate, predominantly pancreatic lipase, amylase, and protease.

Each ULTRASE® (pancrelipase) Capsule contains:

Lipase .................................................. 4,500 U.S.P. Units
Amylase .................................................. 20,000 U.S.P. Units
Protease .................................................. 25,000 U.S.P. Units

Inactive ingredients: povidone, talc, sugar, methacrylic acid copolymer (Type C), triethyl citrate, simethicone emulsion.

What are the possible side effects of pancrelipase?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas.
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight...

Read All Potential Side Effects and See Pictures of Ultrase »

What are the precautions when taking pancrelipase (Ultrase)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage).

This drug may...

Read All Potential Precautions of Ultrase »

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ULTRASE® (pancrelipase) Capsules are indicated for patients with partial or complete exocrine pancreatic insufficiency caused by:

  • Cystic fibrosis (CF)
  • Chronic pancreatitis due to alcohol use or other causes
  • Surgery (pancreatico-duodenectomy or Whipple's procedure, with or without Wirsung duct injection, total pancreatectomy)
  • Obstruction (pancreatic and biliary duct lithiasis, pancreatic and duodenal neoplasms, ductal stenosis)
  • Other pancreatic disease (hereditary, post traumatic and allograft pancreatitis, hemochromatosis, Shwachman's Syndrome, lipomatosis, hyperparathyroidism)
  • Poor mixing (Billroth II gastrectomy, other types of gastric bypass surgery, gastrinoma)

Pancrelipase capsules are effective in controlling steatorrhea.1-9

DOSAGE AND ADMINISTRATION

The enzymatic activity of ULTRASE® (pancrelipase) Capsules is expressed in U.S.P. units. The smallest effective dose should be used. Dosage should be adjusted according to the severity of the exocrine pancreatic insufficiency. Begin therapy with one or two capsules with meals or snacks and adjust dosage according to symptoms. The number of capsules or capsule strength given with meals and/or snacks should be estimated by assessing which dose minimizes steatorrhea and maintains good nutritional status. Dosages should be adjusted according to the response of the patient. Where swallowing of capsules is difficult, they may be opened and the microspheres added to a small quantity of a soft food (e.g., applesauce, gelatin, etc.) that does not require chewing, and swallowed immediately. It is recommended that the total dose of pancrelipase being ingested for a meal or snack be dispersed equally (with fluids) before, during, and after the meal or snack.

SUGGESTIONS FOR THE USE OF PANCREATIC ENZYMES IN CYSTIC FIBROSIS12

  1. Patients should be receiving optimal diet for age and clinical status, recognizing that those with failure to thrive or malnutrition require additional calories and other nutrients for catch-up growth.
  2. Nutrition assessment should be a part of routine clinical evaluations.
  3. Initial dosing of pancreatic enzyme supplements should begin with 500 lipase U/kg/meal using enteric-coated microsphere products.
  4. Patients should be reassessed 2-4 weeks after initiation of therapy. The following items should be assessed:
    • Clinical status, e.g., abdominal symptoms and exam;
    • Nutritional intake and growth (height, weight, head circumference);
    • Character of stools - greasy, oily (for information, not for decision making);
    • Quantitative 72-hour fecal fat when indicated but not less than annually (perform on a normal diet for age);
    • Fat soluble vitamin measures.
  5. Corollaries to dosing suggestions:
    1. Dose may be altered in a stepwise fashion according to the response of the patient (see 4. above).
    2. Dose approaching 2,000 lipase U/kg/meal would indicate the need for further investigation (see below). Patients presently on higher doses should be reevaluated; either immediately decrease the dose or titrate down to a lower dose range at, or below, 2,000 lipase U/kg/meal. Doses > 6,000 lipase U/kg/meal have been associated with colonic strictures.
    3. Pancreatic supplements mixed with applesauce or other acidic food substances should be administered immediately, not stored.
    4. Enteric-coated microspheres should not be crushed.
    5. Enzyme doses (as lipase U/kg/meal) tend to decrease with advancing age.
    6. Patients should accept only product brands prescribed by their physician.
    7. Adjustment of dosage is the responsibility of the physician. Patients should be advised not to adjust doses without consulting their physician. Changes in product or dosage may require an adjustment period.
    8. Complaints transmitted by phone should be investigated thoroughly before dose is adjusted. If indicated, this investigation should include 72-hour fecal fat testing.
    9. Pancreatic supplements should be stored in a cool, dry place and checked regularly for expiration date.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SUPPLIED

ULTRASE® (pancrelipase) Capsules

Gelatin capsules (opaque white and opaque white), imprinted “ULTRASE (pancrelipase) ”. Bottles of 100 (NDC 58914-045-10).

Store at controlled room temperature, between 15°C and 25°C (59°F and 77°F), in a dry place. Do not refrigerate.

REFERENCES

1. Delchier JC, Vidon N, et al. Fate of orally ingested enzymes in pancreatic insufficiency: comparison of two pancreatic enzyme preparations. Aliment Pharmacol Therap. 1991;5:365-378.

2. Duhamel JP, Vidailhet M, et al. Étude multicentrique comparative d'une nouvelle présentation de pancréatine en microgranules gastrorésistants dans I'insuffisance pancréatique exocrine de la mucoviscidose chez l'enfant. Ann Pediatr. 1988;35:69-74.

3. Dutta SK, Tilley DK. The pH-sensitive enteric-coated pancreatic enzyme preparations: an evaluation of therapeutic efficacy in adult patients with pancreatic insufficiency. J Clin Gastroenterol. 1983;5:51-54.

4. Dutta SK, Rubin J, Harvey J. Comparative evaluation of the therapeutic efficacy of a pH-sensitive enteric-coated pancreatic enzyme preparation with conventional pancreatic enzyme therapy in the treatment of exocrine pancreatic insufficiency. Gastroenterol. 1983;84:476-482.

5. Gouerou H, Dain MP, et al. Alipase versus nonenteric-coated enzymes in pancreatic insufficiency. Int J Pancreatol. 1989;5:45-50.

6. Mischler EH, Parrell S, et al. Comparison of effectiveness of pancreatic enzyme preparations in cystic fibrosis. Am J Dis Child. 1982;136:1060-1063.

7. Salen G, Prakash A. Evaluation of enteric-coated microspheres for enzyme replacement therapy in adults with pancreatic insufficiency. Cur Ther Res. 1979;25:650-656.

8. Schneider MU, Knoll-Ruzicka ML, et al. Pancreatic enzyme replacement therapy: comparative effects of conventional and enteric-coated microspheric pancreatin and acid-stable fungal enzyme preparations on steatorrhea in chronic pancreatitis. Hepatogastroenterol. 1985;32:97-102.

9. Halgreen H, Thorsgaard Pedersen N, Worning H. Symptomatic effect of pancreatic enzyme therapy in patients with chronic pancreatitis. Scand J Gastroenterol. 1986;21:104-108.

12. Cystic Fibrosis Foundation Conference on Pancreatic Enzyme Supplementation in the Context of Fibrosing Colonopathy; Washington, D.C., March 23-24, 1995.

REV. June 2008. Marketed as ULTRASE® (pancrelipase) by: AXCAN PHARMA US, INC. 22 Inverness Center, Parkway, Birmingham, AL 35242 USA. www.axcan.com. ULTRASE® (pancrelipase) is manufactured by Eurand International, Milan, Italy using its DIFFUCAPS® technology for Axcan Pharma US, Inc., 22 Inverness Center Parkway, Birmingham, Alabama 35242 USA. FDA revision date: n/a

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most frequently reported adverse reactions to products containing pancrelipase are gastrointestinal in nature. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricemia when the preparations given were pancrelipase in powdered or capsule form, or pancreatin in tablet form.

Colonic strictures have been reported in cystic fibrosis patients treated with both high- and lower-strength enzyme supplements.10 A causal relationship has not been established. The possibility of bowel stricture should be considered if symptoms suggestive of gastrointestinal obstruction occur. Since impaired fluid secretion may be a factor in the development of intestinal obstruction, care should be taken to maintain adequate hydration, particularly in warm weather.11

“Fibrosing colonopathy” is a term used to describe a condition seen in patients with CF who have taken high amounts of pancreatic enzyme supplements ( > 6,000 lipase U/kg/meal). At its most advanced, this condition leads to colonic strictures.

  1. In whom should one consider the diagnosis of fibrosing colonopathy?
    1. Patients with cystic fibrosis who have evidence of partial or complete obstruction, bloody diarrhea or chylous ascites.
    2. Patients who have two of the following three symptoms:

ESPECIALLY if they have:

    • taken > 6,000 lipase U/kg/meal
    • age less than twelve years
    • history of meconium ileus
    • prior intestinal surgery
    • history of recurrent DIOS
    • “inflammatory bowel disease”12

Read the Ultrase (pancrelipase) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

REFERENCES

10. Smyth RL, van Velzen D, et al. Strictures of ascending colon in cystic fibrosis and high-strength pancreatic enzymes. The Lancet. 1994; 343:85-86.

11. Lands L, Zinman R, et al. Pancreatic function testing in meconium disease in CF: two case reports. J Ped Gastroenterol and Nut. 1988; 7:276-279.

12. Cystic Fibrosis Foundation Conference on Pancreatic Enzyme Supplementation in the Context of Fibrosing Colonopathy; Washington, D.C., March 23-24, 1995.

Last reviewed on RxList: 1/20/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Should hypersensitivity occur, discontinue medication and treat symptomatically.

PRECAUTIONS

General

TO PROTECT ENTERIC COATING, MICROSPHERES MUST NOT BE CRUSHED OR CHEWED. Where swallowing of capsules is difficult, they may be opened and the microspheres added to a small quantity of a soft food (e.g., applesauce, gelatin, etc.) that does not require chewing, and swallowed immediately. Contact of the microsphere with foods having a pH greater than 5.5 can dissolve the protective enteric shell.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Methacrylic acid, a minor component of the methacrylic acid copolymer enteric-coating contained in ULTRASE® (pancrelipase) Capsules, has been reported to act as a teratogen in rat embryo cultures. However, the copolymer enteric-coating of ULTRASE® (pancrelipase) Capsules was not mutagenic by the Ames test, and it did not produce chromosome damage in a test for unscheduled DNA synthesis in rat hepatocytes.

Pregnancy: Category C.

Animal reproduction studies have not been conducted with ULTRASE® (pancrelipase) Capsules. It is not known whether ULTRASE® (pancrelipase) Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ULTRASE® (pancrelipase) Capsules should be given to a pregnant woman only if the potential benefit outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether ULTRASE® (pancrelipase) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ULTRASE® (pancrelipase) Capsules are administered to a nursing mother.

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Pancrelipase capsules are contraindicated in patients known to be hypersensitive to pork protein. Pancrelipase capsules are contraindicated in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases.

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

ULTRASE® (pancrelipase) Capsules are designed to prevent inactivation by gastric acid thereby resulting in the delivery of high levels of biologically active enzymes into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, starch into dextrins and sugars, and protein into proteoses and derived substances.

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/28/2005
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/28/2005
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ultrase Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PANCRELIPASE ENTERIC-COATED CAPSULE - ORAL

(pan-kreh-LIP-aze)

COMMON BRAND NAME(S): Creon, Pancrease, Protilase, Ultrase, Zenpep, Zymase

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 (e.g., chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

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, and response to therapy.

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.

Inform your doctor if your condition persists or worsens.

Disclaimer

Ultrase Consumer (continued)

SIDE EFFECTS: Diarrhea, constipation, abdominal pain/cramps, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these rare but very serious side effects occur: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ultrase (pancrelipase) Side Effects Center for a complete guide to possible side effects »

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Ultrase Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: acarbose, miglitol.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting pancrelipase.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this product with others.

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.

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 medicines 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 for more details about how to safely discard your product.

Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.

Ultrase Patient Information Including Side Effects

Brand Names: Cotazym, Creon, Dygase, Kutrase, Ku-Zyme, Ku-Zyme HP, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

Generic Name: pancrelipase (oral) (Pronunciation: pan kre LYE pace)

What is pancrelipase (Ultrase)?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.

Cotazym

green, imprinted with ORGANON, 381

Creon 10

brown/clear, imprinted with SOLVAY, 1210

Lipram

white, imprinted with 0115, 7035

Lipram-CR10

dark brown/light brown, imprinted with 0115, 7036

Pancrease

white, imprinted with Pancrease, McNEIL

Ultrase MT 20

gray/yellow, imprinted with ULTRASE, MT 20

What are the possible side effects of pancrelipase?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas.
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ultrase (pancrelipase) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

Ultrase Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

  • kidney disease;
  • gout;
  • a history of blockage in your intestines;
  • a sudden onset of pancreatitis; or
  • worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack.

Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use.

If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

Ultrase Patient Information including If I Miss a Dose

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pancrelipase.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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