Pancrelipase (Systemic)
   
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Pancrelipase (Systemic)
US Brand Names
• Cotazym
• Cotazym-S
• Creon 5
• Creon 10
• Creon 20
• Enzymase-16
• Ilozyme
• Ku-Zyme HP
• Pancoate
• Pancrease
• Pancrease MT 4
• Pancrease MT 10
• Pancrease MT 16
• Pancrease MT 20
• Panokase
• Protilase
• Ultrase MT 12
• Ultrase MT 20
• Viokase
• Zymase
Canadian Brand Names
• Cotazym
• Cotazym-65 B
• Cotazym E.C.S. 8
• Cotazym E.C.S. 20
• Pancrease
• Pancrease MT 4
• Pancrease MT 10
• Pancrease MT 16
Another commonly used name is lipancreatin .
Description
Pancrelipase (pan-kre-LI-pase) is used to help digestion in certain conditions in which the pancreas is not working properly. It may also be used for other conditions as determined by your doctor.
Pancrelipase contains the enzymes needed for the digestion of proteins, starches, and fats.
Pancrelipase is available only with your doctor's prescription, in the following dosage forms:
Oral
• Capsules (U.S. and Canada)
• Delayed-release capsules (U.S. and Canada)
• Powder (U.S.)
• Tablets (U.S.)
Special Considerations
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pancrelipase, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to pancrelipase, pancreatin, or pork products. Also tell your 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 problems in nursing babies.
Children
This medicine has been tested in children 6 months of age or older and has not been shown to cause different side effects or problems than it does in adults.
Older adults
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pancrelipase in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems
The presence of other medical problems may affect the use of pancrelipase. Make sure you tell your doctor if you have any other medical problems, especially:
• Pancreatitis (sudden, severe inflammation of the pancreas)-Pancrelipase may make this condition worse
Administration
Take this medicine before or with meals and snacks, unless otherwise directed by your doctor.
When prescribing this medicine for your condition, your doctor may also prescribe a personal diet for you. Follow carefully the special diet your doctor gave you . This is most important and necessary for the medicine to work properly and to avoid indigestion. It is important to drink plenty of water while you are on this medicine.
For patients taking the tablet form of this medicine:
• Swallow the tablets quickly with some liquid, without chewing , to avoid mouth irritation.
For patients taking the capsules containing the enteric-coated spheres :
• Swallow the capsule whole.
• Do not crush, break, or chew before swallowing.
• When given to children, the capsule may be opened and sprinkled on a 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 alkaline foods, such as milk and ice cream, which may reduce its effect.
Dosing
The dose of pancrelipase will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of pancrelipase. If your dose is different, do not change it unless your doctor tells you to do so.
• To help digestion:
o For oral dosage form (capsules):
� Older adults, adults, and teenagers-One to three capsules before or with meals and snacks. Your doctor may change your dose if needed.
� Children-The contents of one to three capsules sprinkled on food at each meal. Your doctor may change your dose if needed.
o For oral dosage form (delayed-release capsules):
� Older adults, adults, and teenagers-One to four capsules before or with meals and snacks. Your doctor will decide what your 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 with meals. Your doctor will decide what dose to start with. Your doctor may change your dose if needed. You should take the contents of the capsules with a liquid or a small amount of a soft food that you do not have to chew. You should eat the food with the medicine in it right away and follow that with a glass of water or juice.
� Children under 6 years old-The contents of one to two capsules with meals. Your doctor will decide what dose to start with. Your doctor may change your dose if needed. You should take the contents of the capsules with a liquid or a small amount of a soft food that you do not have to chew. You should eat the food with the medicine in it right away and follow that with a glass of water or juice.
o 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 change your dose if needed.
o For oral dosage form (tablets):
� Older adults, adults, and teenagers-One to three tablets before or 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 as soon as possible. However, if it is almost time for your next dose, skip the missed 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 medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Precautions
Your doctor may recommend that you take pancrelipase with another medicine, such as certain antacids or anti-ulcer medicines. However, antacids that contain calcium carbonate and/or magnesium hydroxate may not let the pancrelipase work properly and should be avoided.
Do not change brands or dosage forms of pancrelipase without first checking with your doctor. Different products may not work in the same way. If you refill 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 breathe in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, wheezing, or tightness in chest.
For patients taking the powder form of this medicine:
• Avoid breathing in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, wheezing, or tightness in chest.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Rare
Skin rash or hives.
With high doses
Diarrhea; intestinal blockage; nausea; stomach cramps or pain.
With very high doses
Blood in urine; joint pain; swelling of feet or lower legs.
With powder dosage form or powder from opened capsules
if breathed inShortness of breath; stuffy nose; tightness in chest; troubled breathing; wheezing.
With tablets
if held in mouthIrritation of the mouth.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
March 28, 2001 
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