Pronunciation:

AM-i-lase, LYE-pase, PROE-tee-ase

Brand Names:

• Creon
• Palcaps
• Pancreaze
• Pancrelipase
• Pangestyme EC
• Panocaps
• Pertzye
• Ultracaps
• Ultresa
• Viokace
• Zenpep
• Viokase

Dosage Forms:

• Tablet
• Capsule
• Capsule, Delayed Release
• Tablet, Enteric Coated

Classifications:

Therapeutic—

Enzyme Replacement

Pharmacologic—

Enzyme

Uses of This Medicine:

Pancrelipase is used to help improve food digestion in certain conditions (eg, cystic fibrosis, pancreatitis) 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 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 this medicine, the following should be considered:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Creon®, Pancreaze®, Pertzye®, and Zenpep® in children.

Appropriate studies have not been performed on the relationship of age to the effects of Ultresa™ in children younger than 12 months of age, and Viokace™ in children. Safety and efficacy have not been established in these age groups.

Older adults—

No information is available on the relationship of age to the effects of Creon®, Pancreaze®, and Pertzye® in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ultresa™, Viokace™, and Zenpep® in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving these medicines.

Breast-feeding—

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.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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:

• Abnormal blood glucose levels, history of or
• 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 (swelling of the pancreas)—Use with caution. May make these conditions worse.

• Allergy to pork products—Use with caution. Pancrelipase contains pork proteins.

• Lactose intolerance—Viokace™ tablets contains lactose, which can make this condition worse.

Proper Use of This Medicine:

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 comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor about anything you do not understand.

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.

For patients taking the tablets:

• Viokace™ tablet is used in combination with certain medicines for stomach ulcer called proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, Nexium®, Prevacid®, Prilosec®).
• Swallow the tablets quickly with some liquid, without chewing, to avoid mouth irritation.

For patients taking the delayed-release capsules:

• Swallow the capsule whole.
• Do not crush, break, or chew before swallowing. Do not hold the capsule in your mouth.
• When given to adults or children who can not swallow the capsule, the capsule may be opened and sprinkled on a small amount (about 10 mL or less) of soft food with a pH of 4.5 or less 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 (about 10 mL or less) of soft acidic food with a pH of 4.5 or less, including applesauce, pureed bananas, or pears, followed by 120 mL of formula or breastfeeding. Do not mix the contents of the capsule directly to alkaline foods, such as milk, breast milk, formula, or ice cream. This could reduce the effect of the medicine.
• Pertzye® capsules may also be given through a gastrostomy tube with a diameter of 14 French or larger.
  • Mix the contents of the capsule with soft foods (including applesauce).
  • Remove the plunger and carefully spoon the mixture into the syringe. Replace the plunger partially back.
  • Connect the syringe into the tube feeding port and inject the medicine for 10 to 12 seconds.
  • Flush the tube with 10 mL of water to rinse all of the medicine into the stomach.
• Throw away any unused portions of the mixture. Do not save for later use.

Do not change the 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.

Dosing—

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 (capsules):
    • Older adults, adults, and teenagers—One to three capsules before or with meals and snacks. Your doctor may adjust your dose if needed.
    • Children—The contents of one to three capsules sprinkled on food at each meal. Your doctor may adjust your dose if needed.
  • For oral dosage form (delayed-release capsules):
    • Older adults, 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—
      • Creon®: 3000 lipase units per 120 milliliters (mL) of infant formula or per breastfeeding.
      • Pancreaze®: 2600 lipase units per 120 mL of infant formula or per breastfeeding.
      • Pertzye®: 4000 lipase units (1 capsule) per 120 mL of infant formula or per breastfeeding.
      • Ultresa™: Use and dose must be determined by your doctor.
      • Zenpep®: 3000 lipase units per 120 mL of infant formula or per breastfeeding.
  • For oral dosage form (powder):
    • Older adults, adults, and teenagers—1/4 teaspoonful (0.7 gram) with meals and snacks. Your doctor may adjust your dose if needed.
    • Children—1/4 teaspoonful with meals. Your doctor may adjust your dose if needed.
  • For oral dosage form (tablets):
    • Older adults, adults, and teenagers—
      • Viokace™: 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.
      • One to three tablets before or with meals and snacks. Your doctor may adjust your dose if needed.
    • Children—
      • Viokace™: Use and dose must be determined by your doctor.
      • One to two tablets with meals.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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.

You may store Creon® capsules at room temperature for 30 days. Throw away any unused medicine after 30 days.

Store the delayed-release capsules in a tightly-closed container to protect them from moisture.

Precautions While Using This Medicine:

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.

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, or tightness in the 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, or tightness in the chest.

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 may cause irritation of the inside of your or your child's mouth if it is not swallowed completely, is crushed or chewed, or is mixed into foods that are not recommended. Follow your doctor's instructions carefully to prevent this.

Pancrelipase may increase uric acid levels in the blood. Check with your doctor if you or your child have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

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, which 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.

Tell your doctor if you have a history of abnormal blood glucose levels before taking Zenpep®.

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 immediately if any of the following side effects occur:

Rare

Skin rash or hives

With high doses

Bowel blockage

diarrhea

nausea

stomach cramps or pain

With very high doses

Blood in the urine

joint pain

swelling of the feet or lower legs

With powder dosage form or powder from opened capsules

(if breathed in)

Stuffy nose

tightness in the chest

trouble breathing

With tablets

(if held in the mouth)

Irritation of the mouth

Incidence not known

Cough

difficulty with swallowing

dizziness

fast heartbeat

itching

noisy breathing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

severe 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

Blurred vision

dry mouth

flushed, dry skin

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

sweating

unexplained weight loss

vomiting

Less common

Abnormal feces

anxiety

bloated feeling

chills

cold sweats

confusion

cool, pale skin

depression

excess air or gas in the stomach or intestines

feeling of fullness

fever

frequent bowel movements

loss of consciousness

muscle aches

nightmares

passing gas

runny nose

seizures

shakiness

slurred speech

sore throat

Incidence not known

Difficulty having a bowel movement

difficulty with moving

muscle aching or cramping

muscle pains or stiffness

muscle spasm

swollen joints

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.