PANCRELIPASE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Cotazym
• Cotazym-S
• Creon 5
• Creon 10
• Creon 20
• Enzymase-16
• Ilozyme
• Ku-Zyme HP
• Lipram 4500
• Lipram-CR10
• Lipram-PN10
• Lipram-UL12
• Lipram-PN16
• Lipram-UL18
• Lipram-CR20
• Lipram-UL20
• Lipram-PN20
• Pancoate
• Pancrease
• Pancrease MT 4
• Pancrease MT 10
• Pancrease MT 16
• Pancrease MT 20
• Panokase
• Protilase
• Ultrase MT 12
• Ultrase MT 20
• Viokase
• Zymase

In Canada?

• Cotazym
• Cotazym-65 B
• Cotazym E.C.S. 8
• Cotazym E.C.S. 20
• Pancrease
• Pancrease MT 4
• Pancrease MT 10
• Pancrease MT 16

Generic name product may be available in the U.S.

Another commonly used name is lipancreatin.

Category

• Diagnostic aid, pancreatic function
• Digestant
• Enzyme, pancreatic, replenisher

Description

Pancrelipase (pan-kre-LI-pase)is used to help digestion in certain conditions in which the pancreas is notworking properly. It may also be used for other conditions as determined byyour doctor.

Pancrelipase contains the enzymes needed for the digestion of proteins,starches, and fats.

Pancrelipase is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Capsules (U.S. and Canada)
• Delayed-release capsules (U.S. and Canada)
• Powder (U.S.)
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For pancrelipase, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to pancrelipase, pancreatin, or pork products. Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in either humans or animals.

Breast-feeding?Pancrelipase has not been reported to cause problemsin nursing babies.

Children?This medicine has been tested in children 6 monthsof age or older and has not been shown to cause different side effects orproblems than it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of pancrelipase in the elderly with use in other age groups,this medicine is not expected to cause different side effects or problemsin older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of pancrelipase. Make sure you tell your doctorif you have any other medical problems, especially:

• Pancreatitis (sudden, severe inflammation of the pancreas)?Pancrelipasemay make this condition worse

Proper Use of This Medicine

Take thismedicine before or with meals and snacks, unless otherwise directed by yourdoctor.

When prescribing this medicine for your condition,your doctor may also prescribe a personal diet for you. Follow carefully thespecial diet your doctor gave you. This is most important and necessaryfor the medicine to work properly and to avoid indigestion. It is importantto drink plenty of water while you are on this medicine.

For patients taking the tablet form of thismedicine:

• Swallow the tablets quickly with some liquid,without chewing, to avoid mouth irritation.

For patients taking the capsules containing the enteric-coatedspheres:

• Swallow the capsule whole.
• Do not crush, break, or chew before swallowing.
• When given to children, the capsule may be opened and sprinkled ona small amount of liquid or soft food that can be swallowed without chewing,such as applesauce or gelatin. However, it should not be mixed with alkalinefoods, such as milk and ice cream, which may reduce its effect.

Dosing?The dose of pancrelipase will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of pancrelipase. If your dose is different,do not change it unless your doctor tells you to do so.

• To help digestion:
  • For oral dosage form (capsules):
    • Older adults, adults, and teenagers?One to three capsules beforeor with meals and snacks. Your doctor may change your dose if needed.
    • Children?The contents of one to three capsules sprinkled onfood at each meal. Your doctor may change your dose if needed.
  • For oral dosage form (delayed-releasecapsules):
    • Older adults, adults, and teenagers?One to four capsules (4000to 20000 units) before or with meals and snacks. Your doctor will decide whatyour dose should be at first. Your doctor may change your dose if needed.
    • Children over 6 years old? The contents of one to four capsules(4000 to 12,000 units) with meals. Your doctor will decide what dose to startwith. Your doctor may change your dose if needed. You should take the contentsof the capsules with a liquid or a small amount of a soft food that you donot have to chew. You should eat the food with the medicine in it right awayand follow that with a glass of water or juice.
    • Children 1 to 6 years old?The contents of one to two capsules(4000 to 8000 units) with meals. Your doctor will decide what dose to startwith. Your doctor may change your dose if needed. You should take the contentsof the capsules with a liquid or a small amount of a soft food that you donot have to chew. You should eat the food with the medicine in it right awayand follow that with a glass of water or juice.
    • Infants 6 months to 1 year old?The contents of half a capsule(2000 units) per meal. Your baby's doctor may change the dose if needed.
    • Infants under 6 months?Use and dose should be determined byyour baby's doctor.
  • For oral dosage form (powder):
    • Older adults, adults, and teenagers?1/4 teaspoonful (0.7 gram)with meals and snacks. Your doctor may change your dose if needed.
    • Children?1/4 teaspoonful with meals. Your doctor may changeyour dose if needed.
  • For oral dosage form (tablets):
    • Older adults, adults, and teenagers?One to three tablets beforeor with meals and snacks. Your doctor may change your dose if needed.
    • Children?One to two tablets with meals.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule, powder, or tablet form of this medicinein the bathroom, near the kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Yourdoctor may recommend that you take pancrelipase with another medicine, suchas certain antacids or anti-ulcer medicines. However, antacids that containcalcium carbonate and/or magnesium hydroxate may not let the pancrelipasework properly and should be avoided.

Do not change brands or dosage forms of pancrelipase without first checkingwith your doctor. Different products may not work in the same way. If yourefill your medicine and it looks different, check with your pharmacist.

For patients taking the capsules containing the powder:

• If the capsules are opened to mix with food, be careful not to breathein the powder. To do so may cause harmful effects such as stuffy nose, shortnessof breath, troubled breathing, wheezing, or tightness in chest.

For patients taking the capsule form containing delayed-releasemicrospheres:

• Swallow whole. Do not crush or chew.
• If you are unable to swallow the capsule whole, the capsule may beopened and the microspheres shaken into a small quantity of a soft food (e.g.,applesauce, gelatin, etc.) which does not require chewing, and swallowed immediately.
• Some foods can dissolve the protective coating of the microspheresand change the effects of this medicine. If you are unsure which foods youcan put the microspheres in, check with your doctor.

For patients taking the powder form of thismedicine:

• Avoid breathing in the powder. To do so may cause harmful effectssuch as stuffy nose, shortness of breath, troubled breathing, wheezing, ortightness in chest.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare

With high doses

With very high doses

With powder dosage form or powder from opened capsules?if breathed in

Shortness of breath; stuffy nose; tightness in chest; troubled breathing; wheezing

With tablets?if held in mouth

Irritation of the mouth

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.