Pancrelipase (Pancrecarb)
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Pancrelipase (Pancrecarb)

PANCRECARB®
(pancrelipase) Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres.

DRUG DESCRIPTION

PANCRECARB® (pancrelipase) contain buffered pancreatic enzymes: lipase, amylase and protease, isolated and concentrated from porcine pancreatic glands. The enzyme containing microspheres are coated with a pH sensitive enteric-coating to provide protection against gastric inactivation of the buffer-stabilized enzymes during gastric passage.

EACH PANCRECARB® (pancrelipase) CONTAINS:

  MS-4 MS-8
Lipase 4,000 U.S.P. Units 8,000 U.S.P. Units
Amylase 25,000 U.S.P. Units 40,000 U.S.P. Units
Protease 25,000 U.S.P. Units 45,000 U.S.P. Units

Inactive ingredients include sodium carbonate, sodium bicarbonate, cellulose acetate phthalate, diethyl phthalate, gelatin, sodium carboxymethyl starch, polyvinylpyrrolidone, talc, ursodiol, and other trace ingredients.

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 Pancrecarb »

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

INDICATIONS

PANCRECARB® (pancrelipase) Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres are indicated for patients with exocrine pancreatic enzyme insufficiency such as: cystic fibrosis, chronic pancreatitis due to alcohol use or other causes, post-pancreatectomy and post-gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy).

DOSAGE AND ADMINISTRATION

Dosing, Duration Of Therapy

Dosage should be individualized and adjusted according to fat intake, severity of steatorrhea and the severity of the exocrine pancreatic insufficiency. Begin therapy with one or two capsules with meals or snacks and adjust dosage according to symptoms. Dose increases, if required, should be made slowly, with careful monitoring of response and symptomatology. It is important to ensure adequate hydration of patients at all times while taking PANCRECARB® (pancrelipase) . Patients with pancreatic enzyme insufficiency should consume a high-caloric diet with unrestricted fat intake, which is appropriate for age and clinical symptomology.

HOW SUPPLIED

PANCRECARB® (pancrelipase) are supplied as follows:

PANCRECARB® (pancrelipase) MS-4 (clear, hard gelatin capsule imprinted in blue with "DCI" and "PANCRECARB® (pancrelipase) MS-4") in bottles of 100 (NDC 59767-002-01).

PANCRECARB® (pancrelipase) MS-8 (clear, hard gelatin capsule imprinted in blue with "DCI" and "PANCRECARB® (pancrelipase) MS-8") in bottles of 100 (NDC 59767-001-01).

PANCRECARB® (pancrelipase) MS-16 (clear, hard gelatin capsule imprinted in blue with "DCI" and "PANCRECARB® (pancrelipase) MS-16") in bottles of 100 (NDC 59767-003-01).

Storage

Store at controlled room temperature 25ºC (77ºF) in a dry place. Do not refrigerate. Do not expose capsules to humid air. Keep bottle tightly closed. Dispense capsules in a tight container.

Manufacturer information. n/a. FDA rev date: n/a

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

SIDE EFFECTS

The most frequently reported adverse reactions to pancrelipase-containing products are gastrointestinal in nature, which may include nausea, vomiting, bloating, cramping, constipation or diarrhea. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenous pancreatic enzymes have been reported to be associated with hyperuricosuria and hyperuricemia. High strength pancrelipase preparation (i.e., those labeled as containing more than 20,000 lipase units per capsule) has been associated with colonic strictures.

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

DRUG INTERACTIONS

No information provided.

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 during the course of treatment, discontinue medication and treat symptomatically. Cases of intestinal stricture and blockage requiring surgical decompression have been reported in cystic fibrosis patients, especially in patients with a history of intestinal complications such as meconium ileus equivalent, short bowel syndrome, surgery or Crohn's disease, who were taking high potency lipase pancreatic enzyme preparations (i.e., those labeled as containing more than 20,000 lipase units per capsule). If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered including the evaluation of pancreatic enzyme therapy. Patients receiving lipase dose of > 2,500 USP units per kilogram per meal should be re-evaluated and the lipase dose either be reduced by 50% or titrated down gradually to the lowest clinically effective dose as determined by 72-hour fecal fat excretion.

PRECAUTIONS

GENERAL - TO PROTECT ENTERIC COATING, MICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED.

The microsphere-containing capsules should be swallowed with liquids at the start of a meal. Where swallowing of capsules is difficult, the capsules may be carefully opened and the microspheres shaken into a small quantity of soft food such as applesauce, jelly, jello, etc., which does not require chewing, and swallowed immediately, followed by a glass of water or juice to ensure complete swallowing. Prolonged contact of the microspheres with foods having a pH greater than 5.5 can weaken the integrity of the protective enteric coat and compromise the potency of the enzymes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed with PANCRECARB® (pancrelipase) delayed-release capsules.

Pregnancy/Reproduction

Pregnancy Category C. Diethylphthalate, an enteric coating component of PANCRECARB® (pancrelipase) have been shown to be teratogenic in rats following high intraperitoneal dosing. When this coating was given orally to rats up to 100 times the human dose, however, no teratogenic or embryocidal effects were observed.

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

OVERDOSE

No information provided.

CONTRAINDICATIONS

PANCRECARB® (pancrelipase) Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres are contraindicated in patients known to be hypersensitive to pork protein or any other ingredient of this product.

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

CLINICAL PHARMACOLOGY

The buffer-stabilized pancreatic enzymes in PANCRECARB® (pancrelipase) Delayed-Release are enteric-coated with a gastric acid resistant polymer to protect the enzymes during gastric transit into the duodenum.

After being swallowed, the gelatin capsules dissolve in the gastric juice within minutes and the released microspheres disperse with food in the stomach. Upon passing into the duodenum, the enteric-coated PANCRECARB® (pancrelipase) microspheres are activated at approximately pH 5.5, discharge their digestive enzymes and the released digestive enzymes help to re-establish the natural digestive conditions in the intestine.

The digestive enzymes in PANCRECARB® (pancrelipase) act locally in the gastrointestinal tract.

The digestive enzymes hydrolyze fats into glycerol and fatty acids, proteins into peptides and amino acids, and starch into dextrins and maltrose.

Once the digestive enzymes accomplish their catalytic function to hydrolyze food, the digestive enzymes may be inactivated by anti-enzymes which are secreted by the intestinal mucosa or digested by proteases. The digested enzyme fragments may be absorbed from the intestine and subsequently excreted into the urine. The inactivated enzymes are excreted in the feces.

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

PATIENT INFORMATION

Patients Should Be Advised That:

  • PANCRECARB® (pancrelipase) should not be crushed or chewed.
  • PANCRECARB® (pancrelipase) capsules should be swallowed with liquids at the start of a meal.
  • PANCRECARB® (pancrelipase) , when removed from the gelatin capsule, should be swallowed immediately and not retained in the mouth.
  • Liquids should be consumed liberally while dosing with PANCRECARB® (pancrelipase)

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients Should Be Advised That:

  • PANCRECARB® (pancrelipase) should not be crushed or chewed.
  • PANCRECARB® (pancrelipase) capsules should be swallowed with liquids at the start of a meal.
  • PANCRECARB® (pancrelipase) , when removed from the gelatin capsule, should be swallowed immediately and not retained in the mouth.
  • Liquids should be consumed liberally while dosing with PANCRECARB® (pancrelipase)

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PANCRECARB®
(pancrelipase) Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres.

DRUG DESCRIPTION

PANCRECARB® (pancrelipase) contain buffered pancreatic enzymes: lipase, amylase and protease, isolated and concentrated from porcine pancreatic glands. The enzyme containing microspheres are coated with a pH sensitive enteric-coating to provide protection against gastric inactivation of the buffer-stabilized enzymes during gastric passage.

EACH PANCRECARB® (pancrelipase) CONTAINS:

  MS-4 MS-8
Lipase 4,000 U.S.P. Units 8,000 U.S.P. Units
Amylase 25,000 U.S.P. Units 40,000 U.S.P. Units
Protease 25,000 U.S.P. Units 45,000 U.S.P. Units

Inactive ingredients include sodium carbonate, sodium bicarbonate, cellulose acetate phthalate, diethyl phthalate, gelatin, sodium carboxymethyl starch, polyvinylpyrrolidone, talc, ursodiol, and other trace ingredients.

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

PANCRECARB®
(pancrelipase) Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres.

DRUG DESCRIPTION

PANCRECARB® (pancrelipase) contain buffered pancreatic enzymes: lipase, amylase and protease, isolated and concentrated from porcine pancreatic glands. The enzyme containing microspheres are coated with a pH sensitive enteric-coating to provide protection against gastric inactivation of the buffer-stabilized enzymes during gastric passage.

EACH PANCRECARB® (pancrelipase) CONTAINS:

  MS-4 MS-8
Lipase 4,000 U.S.P. Units 8,000 U.S.P. Units
Amylase 25,000 U.S.P. Units 40,000 U.S.P. Units
Protease 25,000 U.S.P. Units 45,000 U.S.P. Units

Inactive ingredients include sodium carbonate, sodium bicarbonate, cellulose acetate phthalate, diethyl phthalate, gelatin, sodium carboxymethyl starch, polyvinylpyrrolidone, talc, ursodiol, and other trace ingredients.

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

PANCRECARB®
(pancrelipase) Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres.

DRUG DESCRIPTION

PANCRECARB® (pancrelipase) contain buffered pancreatic enzymes: lipase, amylase and protease, isolated and concentrated from porcine pancreatic glands. The enzyme containing microspheres are coated with a pH sensitive enteric-coating to provide protection against gastric inactivation of the buffer-stabilized enzymes during gastric passage.

EACH PANCRECARB® (pancrelipase) CONTAINS:

  MS-4 MS-8
Lipase 4,000 U.S.P. Units 8,000 U.S.P. Units
Amylase 25,000 U.S.P. Units 40,000 U.S.P. Units
Protease 25,000 U.S.P. Units 45,000 U.S.P. Units

Inactive ingredients include sodium carbonate, sodium bicarbonate, cellulose acetate phthalate, diethyl phthalate, gelatin, sodium carboxymethyl starch, polyvinylpyrrolidone, talc, ursodiol, and other trace ingredients.

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

Pancrecarb 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 (Pancrecarb)?

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 Pancrecarb (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.

Pancrecarb 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.

Pancrecarb 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.

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