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Pancrelipase is a prescription medication for people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. Pancrelipase is a mixture of enzymes normally produced by the pancreas that help the body digest foods.

Pancrelipase is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cornerstone Therapeutics, Inc.

Pancrelipase may cause serious side effects, including:

• See "Drug Precautions".
• Irritation of the inside of your mouth. This can happen if pancrelipase is not swallowed completely.
• Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.
• Allergic reactions including trouble breathing, skin rash, itching, or swollen lips.

Call your doctor right away if you have any of these symptoms.

The most common side effects of pancrelipase include:

• diarrhea
• upset stomach (indigestion)
• cough

Other possible side effects:

Pancrelipase and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of pancrelipase. For more information, ask your doctor or pharmacist.

No pancrelipase drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Pancrelipase may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. 

Call your doctor right away if you have any unusual or severe:

• stomach area (abdominal) pain
• bloating
• trouble passing stool (having bowel movements)
• nausea, vomiting, or diarrhea

Take pancrelipase exactly as prescribed by your doctor. Do not take more or less pancrelipase than directed by your doctor.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pancrelipase there are no specific foods that you must exclude from your diet when receiving pancrelipase.

Before taking pancrelipase, tell your doctor about all of your medical conditions, including if you:

• are allergic to pork (pig) products
• have a history of blockage of your intestines or scarring or thickening of your bowel wall (fibrosing colonopathy)
• have gout, kidney disease, or high blood uric acid (hyperuricemia).
• have trouble swallowing capsules
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if pancrelipase will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if pancrelipase passes into your breast milk. You and your doctor should decide if you will take pancrelipase or breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and dietary or herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if pancrelipase will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if pancrelipase passes into your breast milk. You and your doctor should decide if you will take pancrelipase or breastfeed.

Take pancrelipase capsules exactly as your doctor tells you.

• You should not switch pancrelipase with any other pancreatic enzyme product without first talking with your doctor.
• Do not take more capsules in a day than the number your doctor tells you to take (total daily dose)
• Always take pancrelipase with a meal or snack and plenty of fluid. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose.
• Your doctor may change your dose based on the amount of fatty foods you eat or based on your weight.
• Pancrelipase capsules should be swallowed whole. Do not crush or chew the pancrelipase capsules or their contents, and do not hold the capsule or contents in your mouth. Crushing, chewing or holding the pancrelipase capsules in your mouth may cause irritation in your mouth or change the way the pancrelipaseworks in your body.

Giving pancrelipase to children and adults

1. You should not divide the capsule contents into small amounts to give small doses of pancrelipase.
2. Swallow pancrelipase capsules whole and take them with enough liquid to swallow them right away.
3. If you have trouble swallowing capsules, open the capsules and mix the contents with a small amount of acidic food such as applesauce. Ask your doctor about other foods you can mix with pancrelipase.
4. If you mix pancrelipase with food, swallow it right after you mix it and drink plenty of water or juice to make sure the medicine is swallowed completely. Do not store pancrelipase that is mixed with food. Throw away any unused portion of capsule contents.
5. If you forget to take pancrelipase, wait until your next meal and take your usual number of capsules. Take your next dose at your usual time. Do not take two doses at one time.

Take pancrelipase exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

Children Older than 12 Months and Younger than 4 Years and Weight 8 kg or Greater 
Children older than 12 months and younger than 4 years, weighing less than 8 kg, should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children.

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Weight 16 kg or Greater and Adults 
Children 4 years and older, weighing less than 16 kg, should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children.

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed pancrelipase dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

Limitations on Dosing 
Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. 

If symptoms and signs of steatorrhea persist, the dosage may be increased by a healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in responses to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted.

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures, indicative of fibrosing colonopathy, in children with cystic fibrosis less than 12 years of age. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Use of pancrelipase in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended.

If you take too much pancrelipase, call your local Poison Control Center or seek emergency medical attention right away.

Active Ingredients: lipase, protease, amylase

Inactive Ingredients:

• The hard gelatin capsules contain: sodium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc.
• The imprinting ink on the 8,000 units of lipase; 28,750 units of protease; 30,250 of amylase capsules contain: FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac and ammonium hydroxide. 
• The imprinting ink on the 16,000 units of lipase; 57,500 units of protease; 60,500 of amylase capsules contain: FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac.

How do I store pancrelipase?

• Store pancrelipase at room temperature 68ºF to 77ºF (20ºC to 25ºC).
• Keep pancrelipase in a dry place and in the original container.
• After opening the bottle, keep it tightly closed between uses to keep your medicine dry (protect it from moisture).
• The pancrelipase bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not eat or throw away the packet (desiccant) in your medicine bottle.

Keep pancrelipase and all medicines out of the reach of children.