pertzye_277972_277973

Adult Dosing 

Dosage forms:  lipase/protease/amylase: 8K/28.75K/30.25K, 16K/57.5K/60.5K units DR

exocrine pancreatic insufficiency 胰液分泌不足

[500-2500 lipase units/kg PO w/ meals/snacks]
Start: 500 lipase units/kg PO w/ meals/snacks; Max: 2500 lipase units/kg/meal; 10,000 lipase units/kg/day; 4000 lipase units/g fat ingested/day; Alt: 500-4000 lipase units/g fat ingested/day PO div w/ meals/snacks; Info: for EPI due to cystic fibrosis or other conditions; snack dose usually half of meal dose; do not cut/crush/chew; may open caps and sprinkle on soft food w/ pH 4.5 or less

Peds Dosing 

Dosage forms:  lipase/protease/amylase: 8K/28.75K/30.25K, 16K/57.5K/60.5K units DR

exocrine pancreatic insufficiency

[<1 yo]
Dose: 3000 lipase units PO per breastfeeding or 4 oz formula; Max: 2500 lipase units/kg/feeding; 10,000 lipase units/kg/day; 4000 lipase units/g fat ingested/day; Info: for EPI due to cystic fibrosis or other conditions; do not cut/crush/chew; may open caps and sprinkle on soft food w/ pH 4.5 or less; give before breastfeeding or formula

exocrine pancreatic insufficiency

[1-4 yo]
Dose: 1000-2500 lipase units/kg PO w/ meals/snacks; Start: 1000 lipase units/kg PO w/ meals/snacks; Max: 2500 lipase units/kg/meal; 10,000 lipase units/kg/day; 4000 lipase units/g fat ingested/day; Alt: 500-4000 lipase units/g fat ingested/day PO div w/ meals/snacks; Info: for EPI due to cystic fibrosis or other conditions; snack dose usually half of meal dose; do not cut/crush/chew; may open caps and sprinkle on soft food w/ pH 4.5 or less

exocrine pancreatic insufficiency

[>4 yo]
Dose: 500-2500 lipase units/kg PO w/ meals/snacks; Start: 500 lipase units/kg PO w/ meals/snacks; Max: 2500 lipase units/kg/meal; 10,000 lipase units/kg/day; 4000 lipase units/g fat ingested/day; Alt: 500-4000 lipase units/g fat ingested/day PO div w/ meals/snacks; Info: for EPI due to cystic fibrosis or other conditions; snack dose usually half of meal dose; do not cut/crush/chew; may open caps and sprinkle on soft food w/ pH 4.5 or less

Safety/Monitoring 

Pregnancy: C

Lactation: Safety Unknown

Monitoring Parameters 
no routine tests recommended

Pharmacology 

Metabolism: GI tract; CYP450: none; Info: minimal systemic absorption

Excretion: feces; Half-life: unknown

Subclass: Digestive Enzymes

Mechanism of Action
disintegrates into trypsin, amylase, and lipase, which break down proteins, carbohydrates, and fats

Patient Education

  • Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, 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

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.

 

What is pancrelipase?

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.

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.

 

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 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.

 

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.

 

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