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Generic Name: pancrelipase (Oral route)
AM-i-lase, LYE-pase, PROE-tee-ase
Commonly used brand name(s)
In the U.S.
- Pangestyme EC
Available Dosage Forms:
- Capsule, Delayed Release
- Tablet, Chewable
Therapeutic Class: Enzyme Replacement
Pharmacologic Class: Enzyme
Uses For Ultresa
Pancrelipase is used to help improve food digestion in certain conditions (eg, cystic fibrosis) where the pancreas is not working properly. Pancrelipase contains the enzymes (including lipases, proteases, and amylases) needed for the digestion of proteins, starches, and fats.
This medicine is available only with your doctor's prescription.
Before Using Ultresa
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pancrelipase in children.
No information is available on the relationship of age to the effects of pancrelipase in geriatric patients.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with 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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Fibrosing colonopathy (bowel disorder) or
- Gout or
- Hyperuricemia (high uric acid in the blood) or
- Hyperuricosuria (high uric acid in the urine) or
- Intestinal (bowel) blockage, history of or
- Kidney disease or
- Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.
- Allergy to pork products—Use with caution. Pancrelipase contains pork proteins.
Proper Use of pancrelipase
This section provides information on the proper use of a number of products that contain pancrelipase. It may not be specific to Ultresa. Please read with care.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with meals or snacks and enough liquid to swallow it completely, unless otherwise directed by your doctor.
When prescribing this medicine for your condition, your doctor may also prescribe a personal diet for you. Follow the special diet carefully. This is necessary for the medicine to work properly. It is also important to drink plenty of water while you are on this medicine.
To use the delayed-release capsules:
- Swallow the capsule whole. Do not crush, break, or chew it. Do not hold the capsule in your mouth.
- When given to children, the capsule may be opened and sprinkled on a small amount of soft food that can be swallowed without chewing, such as applesauce. This mixture must be swallowed immediately and followed with a glass of water or juice. This will ensure complete swallowing of the contents of the capsule and avoid mouth irritation.
- When given to infants, the contents of the capsule may be put directly into the infant's mouth or mixed with a small amount of applesauce, pureed bananas, or pears, and given before each feeding.
- Do not mix the contents of the capsule directly to infant formula or breast milk. This could reduce the effect of the medicine.
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.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- To help digestion:
- For oral dosage form (delayed-release capsules):
- Adults and children older than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
- Children older than 12 months and younger than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 1000 lipase units per kg of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
- Children up to 12 months old—4000 lipase units (1 capsule) per 120 mL of infant formula or per breastfeeding.
- For oral dosage form (delayed-release capsules):
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the delayed-release capsules in a tightly-closed container to protect them from moisture.
Precautions While Using Ultresa
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.
Check with your doctor right away if you or your child have unusual or severe abdominal or stomach pain, trouble passing stool, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder called fibrosing colonopathy.
This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using this medicine.
Ultresa 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 immediately if any of the following side effects occur:Incidence not known
- difficulty breathing
- difficulty swallowing
- fast heartbeat
- hives, itching, or skin rash
- noisy breathing
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
- trouble passing stool
- unusual or severe abdominal or stomach pain
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- stomach discomfort, upset, or pain
- difficulty having a bowel movement (stool)
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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More about Ultresa (pancrelipase)
- Side Effects
- During Pregnancy
- Dosage Information
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- Drug class: digestive enzymes