"The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Current tests used to diagnose gastroparesis "...
DOSAGE AND ADMINISTRATION
PERTZYE is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of PERTZYE should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see Limitations on Dosing below).
Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1,2,3 PERTZYE should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.
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 PERTZYE 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.1, 2, 3
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 response 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 6000 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 [see WARNINGS AND PRECAUTIONS]. 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 PERTZYE 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.
PERTZYE should always be taken as prescribed by a healthcare professional.
Children and Adults
PERTZYE should be taken during meals or snacks, with sufficient fluid. PERTZYE capsules should be swallowed whole. Do not crush or chew the capsules and the capsule contents.
For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents mixed with small amounts of acidic soft food with a pH of 4.5 or less (e.g., applesauce). The PERTZYE soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth to avoid mucosal irritation.
Any unused portion of capsule contents should be discarded, and not used for subsequent dosing. The remaining exposed contents may lose potency and become less effective.
Dosage Forms And Strengths
The active ingredient in PERTZYE evaluated in clinical trials is lipase. PERTZYE is dosed by lipase units.
- 8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase. Delayed-release capsules have a clear body printed in blue with “8” and a clear cap printed with a blue circular stripe and “DCI”
- 16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase. Delayed-release capsules have a clear body printed in red with “16” and a clear cap printed with a red circular stripe and “DCI”
PERTZYE (pancrelipase) Delayed-Release Capsules
8,000 USP units of lipase; 28,750 USP units of protease; 30,250 units of amylase.
Each PERTZYE delayed-release capsule has a clear body printed in blue with “8” and a clear cap printed with a blue circular stripe and “DCI”. Capsules are supplied in bottles of 100 (NDC 59767-008-01) or 250 (NDC 59767-008-02).
PERTZYE (pancrelipase) Delayed-Release Capsules
16,000 USP units of lipase; 57,500 USP units of protease; 60,500 units of amylase.
Each PERTZYE delayed-release capsule has a clear body printed in red with “16” and a clear cap printed with a red circular stripe and “DCI”. Capsules are supplied in bottles of 100 (NDC 59767-016-01) or 250 (NDC 59767-016-02).
Storage and Handling
Store at room temperature 20-25°C (68-77°F), brief excursions permitted to 15-40°C (59- 104°F). PERTZYE hard gelatin capsules should be stored in a dry place in the original container. After opening, keep the container tightly closed between uses to protect from moisture.
PERTZYE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten or thrown away. The desiccant packet will protect the product from moisture.
Do not crush PERTZYE delayed-release capsules or the capsule contents.
1. Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.
2. Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.
3. Stallings VA, Start LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.
Manufactured and Distributed in the USA by: Digestive Care, Inc., Bethlehem, PA 18017. Revised: May 2012
Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Pertzye Information
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