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|Ultrase MT 12

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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 .

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.)

Before Using This Medicine

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

Proper Use of This Medicine

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:
- 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.
- For oral dosage form (delayed-release capsules):
  - Older adults, adults, and teenagers—One to four capsules (4000 to 20000 units) 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 (4000 to 12,000 units) 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 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 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.
  - 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 by your 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 change your dose if needed.
- 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 While Using This Medicine

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 capsule form containing delayed-release microspheres :

Swallow whole. Do not crush or chew.
If you are unable to swallow the capsule whole, the capsule may be opened 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 microspheres and change the effects of this medicine. If you are unsure which foods you can put the microspheres in, check with your doctor.

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 of This Medicine

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 in

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

With tablets—if held in mouth

Irritation 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.

Revised: 09/16/2004

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