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PANCREAZE
Overview
What is PANCREAZE?
PANCREAZE 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.
Each capsule for oral administration contains enteric-coated microtablets that are each approximately 2 mm in diameter.
The active ingredient evaluated in clinical trials is lipase. PANCREAZE is dosed by lipase units. Other active ingredients include protease and amylase.
Inactive ingredients in PANCREAZE 2,600 USP units of lipase include colloidal silicon dioxide, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate.
Inactive ingredients in other strengths of PANCREAZE include cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, montan glycol wax, simethicone emulsion, talc and triethyl citrate.
PANCREAZE is available in five color coded strengths. Each PANCREAZE capsule strength contains the specified amounts of lipase, protease, and amylase as follows:
2,600 USP units of lipase;
4,200 USP units of lipase
10,500 USP units of lipase
16,800 USP units of lipase;
21,000 USP units of lipase;
What does PANCREAZE look like?
What are the available doses of PANCREAZE?
The active ingredient in PANCREAZE evaluated in clinical trials is lipase. PANCREAZE is dosed by lipase units.
PANCREAZE is available in 5 color coded capsule strengths.
Other active ingredients include protease and amylase. Each PANCREAZE 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 PANCREAZE?
Pediatric Patients
How should I use PANCREAZE?
PANCREAZE (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
PANCREAZE is not interchangeable with other pancrelipase products.
PANCREAZE is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of PANCREAZE should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see below).
Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences. PANCREAZE should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs with one exception. The Conferences recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months. PANCREAZE is available in a 2,600 lipase unit capsule. The recommended dose of PANCREAZE in infants up to 12 months is 2,600 lipase units per 120 mL of formula or per breast-feeding. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.
What interacts with PANCREAZE?
Sorry No Records found
What are the warnings of PANCREAZE?
Sorry No Records found
What are the precautions of PANCREAZE?
Sorry No Records found
What are the side effects of PANCREAZE?
Sorry No records found
What should I look out for while using PANCREAZE?
None.
What might happen if I take too much PANCREAZE?
In Study 1, a 10 year-old patient was administered a PANCREAZE dose of 12,399 lipase units per kilogram per day for the duration of the open-label and randomized withdrawal periods. The patient experienced mild abdominal pain throughout both study periods. Abnormal chemistry data at the end of the study included mild elevations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum phosphate. Abnormal hematology data at the end of the study included mild elevations of hematocrit. No abnormalities from analyses of urinalysis or uric acid were noted.
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 PANCREAZE?
Storage and HandlingAvoid heat. PANCREAZE 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. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE 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. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE 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. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE 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. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE 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. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Nitrofurantoin Capsules USP (monohydrate/macrocrystals), for oral administration, are available as:100 mg:E Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Nitrofurantoin Capsules USP (monohydrate/macrocrystals), for oral administration, are available as:100 mg:E Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Nitrofurantoin Capsules USP (monohydrate/macrocrystals), for oral administration, are available as:100 mg:E Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Nitrofurantoin Capsules USP (monohydrate/macrocrystals), for oral administration, are available as:100 mg:E Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
None.Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.
Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.
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. 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. 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 absorptionPatients 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.
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.
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