Pancreaze

What is Pancreaze?

• Pancreaze (pancrelipase lipase, pancrelipase amylase, and pancrelipase protease) is a combination of porcine-derived lipases, proteases, and amylases used for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

What are the uses of this medicine?

• PANCREAZE is used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food.
• PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

How does this medicine work?

• The pancreatic enzymes in PANCREAZE catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No drug interactions have been identified.
• No formal interaction studies have been conducted.

Is this medicine FDA approved?

• Initial U.S. Approval – 2010

How should this medicine be used?

• PANCREAZE is not interchangeable with any other pancrelipase product.

Recommended dosage: Infants (up to 12 months):

• Infants may be given 2,600 lipase units per 120 mL of formula or per breast-feeding.
• Do not mix PANCREAZE delayed-release capsule contents directly into formula or breast milk prior to administration.

Children Older than 12 Months and Younger than 4 Years:

• Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal 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 Adults:

• Enzyme dosing should begin with 500 lipase units/kg of body weight per meal 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.

• Do not take more capsules in a day than the number your doctor tells you to take (total daily dose).

Administration:

• Always take PANCREAZE 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.
• Do not crush or chew the PANCREAZE capsules or their contents, and do not hold the capsule or contents in your mouth. Crushing, chewing or holding the PANCREAZE capsules in your mouth may cause irritation in your mouth or change the way PANCREAZE works in your body.

PANCREAZE to infants (children up to 12 months):

• Give PANCREAZE right before each feeding of formula or breast milk.
• Do not mix PANCREAZE capsule contents directly into formula or breast milk.
• Open the capsules and sprinkle the contents directly into your infant's mouth or mix the contents in a small amount of soft food such as applesauce.
• If you sprinkle the PANCREAZE on food, give the PANCREAZE and food mixture to your child right away. Do not store PANCREAZE that is mixed with food.
• Give your child enough liquid to completely swallow the PANCREAZE contents or the PANCREAZE and food mixture.
• Look into your child's mouth to make sure that all of the medicine has been swallowed.

Giving PANCREAZE to children and adults:

• Swallow PANCREAZE capsules whole and take them with enough liquid to swallow them right away.
• If you have trouble swallowing capsules, open the capsules and sprinkle the contents on a small amount of acidic food such as applesauce.
• If you sprinkle PANCREAZE on 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 PANCREAZE that is mixed with food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release capsules

This medicine is available in fallowing brand namesː

• PANCREAZE

What side effects can this medication cause?

The most common side effects of this medicine include:

• Pain in your stomach (abdominal area)
• Gas

PANCREAZE may cause serious side effects, including:

• fibrosing colonopathy
• Irritation of the inside of your mouth
• Increase in blood uric acid levels
• Allergic reactions

What special precautions should I follow?

• Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Exercise caution when doses of PANCREAZE exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).
• Care should be taken to ensure that no drug is retained in the mouth. To avoid irritation of oral mucosa, do not chew PANCREAZE or retain in the mouth.
• Caution should be exercised when prescribing PANCREAZE to patients with gout, renal impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels. Exercise caution when prescribing PANCREAZE to patients with gout, renal impairment, or hyperuricemia.
• PANCREAZE 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. There is theoretical risk of viral transmission with all pancreatic enzyme products including PANCREAZE.
• Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• abdominal pain
• mild elevations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum phosphate
• mild elevations of hematocrit
• fibrosing colonopathy
• colonic strictures
• hyperuricosuria
• hyperuricemia

Can this medicine be used in pregnancy?

• Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The short-term safety and effectiveness of PANCREAZE were assessed in two clinical studies in pediatric patients.
• The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase consisting of the same active ingredients (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic insufficiency due to cystic fibrosis has been described in the medical literature and through clinical experience.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: lipase, protease, amylase

• Inactive ingredients in all strengths of PANCREAZE: colloidal silicon dioxide, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate. The capsule shell contains hypromellose, titanium dioxide and iron oxide.

Who manufactures and distributes this medicine?

Finished Product Manufactured at: Nordmark Pharma GmbH Uetersen, Germany.

Manufactured by: VIVUS, Inc. E. Hamilton Ave., Suite 550 Campbell, CA , USA

What should I know about storage and disposal of this medication?

• Store PANCREAZE at room temperature below 77°F (25°C). Avoid heat.
• Keep PANCREAZE in a dry place and in the original container.
• After opening the bottle, keep it closed tightly between uses.
• All PANCREAZE bottles contain a desiccant canister. Do not eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.

• Dailymed label info on Pancreaze
• FDA Pancreaze

Pancreaze Resources
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