Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

PERTZYE

×

Overview

What is PERTZYE?

PERTZYE is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.

Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.

Each PERTZYE delayed-release capsule for oral administration contains bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase.

The active ingredient evaluated in clinical trials is lipase. PERTZYE is dosed by lipase units. Other active ingredients include protease and amylase.

Inactive ingredients in PERTZYE include sodium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc and are contained in hard gelatin capsules.

4,000 USP units of lipase

8,000 USP units of lipase

16,000 USP units of lipase

24,000 USP units of lipase



What does PERTZYE look like?



What are the available doses of PERTZYE?

The active ingredient in PERTZYE evaluated in clinical trials is lipase. PERTZYE is dosed by lipase units.

PERTZYE is available in 3 color coded capsule strengths. Each PERTZYE delayed-release capsule strength contains the specified amounts of lipase, protease and amylase as follows:

What should I talk to my health care provider before I take PERTZYE?

How should I use PERTZYE?

PERTZYE (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Dosage

PERTZYE is not substitutable with any other pancrelipase products.

PERTZYE is administered orally or via a gastrostomy tube. 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 ( ).

Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences. 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.

Infants (up to 12 months)

Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breast-feeding. Do not mix PERTZYE capsule contents directly into formula or breast milk prior to administration [see Dosage and 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 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 Adults

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.

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 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 [see Warnings and Precautions (5.1)]. 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.

Administration

PERTZYE should always be taken as prescribed by a healthcare professional.

Infants (up to 12 months)

PERTZYE should be administered to infants immediately prior to each feeding, using a dosage of 4,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Contents of the capsule may be mixed with approximately 10 mL of soft acidic food with a pH of 4.5 or less (e.g., applesauce). Contents of the capsule may also be administered directly to the mouth. Administration should be followed by breast milk or formula. Do not mix contents of the capsule directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that the PERTZYE microspheres are not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa [ ( )].

Children and Adults

Alternatively, the contents of one or two 4,000 USP lipase unit capsules can be administered with soft foods with a pH of 4.0 or less (e.g., applesauce) via a gastrostomy tube with a diameter of 14 French or larger.

Gastrostomy Tube Administration Instructions (14 French Gastrostomy Tube or Larger)

Only perform gastrostomy tube administration with the contents of the 4,000 USP lipase unit capsule of PERTZYE. The contents of no more than two capsules may be administered at a time.


What interacts with PERTZYE?

Sorry No Records found


What are the warnings of PERTZYE?

Sorry No Records found


What are the precautions of PERTZYE?

Sorry No Records found


What are the side effects of PERTZYE?

Sorry No records found


What should I look out for while using PERTZYE?

None.


What might happen if I take too much PERTZYE?

In a clinical study, a 10 year-old patient was administered lipase doses over the maximum lipase dose of 2500 lipase units/kg/meal (Dose Stabilization 2799 lipase units/kg/meal; Wash-out/Re-Stabilization 2783 lipase units/kg/meal; and PERTZYE 2720 lipase units/kg/meal). Despite the administration of this slightly (10%) higher than recommended dose, no gastrointestinal AEs were reported for this subject.

Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures . High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment .


How should I store and handle PERTZYE?

Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.PERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and HandlingPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and HandlingPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and HandlingPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and HandlingPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and HandlingPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and HandlingPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release CapsulesPERTZYE (pancrelipase) Delayed-Release Capsules24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase.Each PERTZYE delayed-release capsule has a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”. Delayed-release capsules are supplied in bottles of 80 (NDC 59767-024-01) or 200 (NDC 59767-024-02).Storage and Handling


×

Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The pancreatic enzymes in PERTZYE 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 maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Non-Clinical Toxicology
None.

Octreotide acetate has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of octreotide acetate with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection.

Patients receiving insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may require dose adjustments of these therapeutic agents.

Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine. Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormones. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution.

5.1 Fibrosing Colonopathy

Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children less than 12 years of age.1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs.1 It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [ ( )].

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. Patients 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.

5.2 Potential for Irritation to Oral Mucosa

Care should be taken to ensure that no drug is retained in the mouth. PERTZYE should not be crushed or chewed or mixed in foods having a pH greater than . These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity [ ( )]. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents mixed with a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, or administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger (only for the 4,000 USP lipase unit capsule strength) [ ( )]. If administered orally, the PERTZYE-soft food mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

5.3 Potential for Risk of Hyperuricemia

Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels. Consider monitoring serum uric acid levels in patients with hyperuricemia, gout, or renal impairment.

5.4 Potential Viral Exposure from the Product Source

PERTZYE is sourced from pancreatic tissue from swine used for food consumption. Although the risk that PERTZYE will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

5.5 Allergic Reactions

Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase). The risks and benefits of continued PERTZYE treatment in patients with severe allergy should be taken into consideration with the overall clinical needs of the patient.

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) include fibrosing colonopathy, hyperuricemia and allergic reactions .

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

Rate this treatment and share your opinion


Learn about User Reviews

Helpful tips to write a good review:

  1. Only share your first hand experience as a consumer or a care giver.
  2. Describe your experience in the Comments area including the benefits, side effects and how it has worked for you. Do not provide personal information like email addresses or telephone numbers.
  3. Fill in the optional information to help other users benefit from your review.

Reason for Taking This Treatment

(required)

Click the stars to rate this treatment

Effectiveness (required)

This medication has worked for me.




Ease of Use (required)

This medication has been easy for me to use.




Satisfaction (required)

Overall, I have been satisfied with my experience.




Write a brief description of your experience with this treatment:

2000 characters remaining

Optional Information

Help others benefit from your review by filling in the information below.
I am a:
Gender:
×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
×

Tips

Tips

×

Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).