Detailed description page of ThPDB2
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Th1071 details |
| Primary information | |
|---|---|
| ID | 10422 |
| Therapeutic ID | Th1071 |
| Protein Name | Pancrelipase |
| Sequence | >Th1071_Pancrelipase QYSPNTQQGRTSIVHLFEWRWVDI |
| Molecular Weight | 131000 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 6.44 |
| Hydrophobicity | NA |
| Melting point | 48-50 |
| Half-life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so limination half-life is not relevant |
| Description | Pancrelipase is an enzyme mixture isolated from porcine or bovine pancreas, sometimes called pancreatin. It contains 3 enzymes: amylase, lipase, and a protease (chymotrypsin). Pancrelipase is marketed under several brand names such as Ultresa and Viokace. |
| Indication/Disease | For treatment of exocrine pancreatic insufficiency in cystic fibrosis (Ultresa), chronic pancreatitis (Viokace in combination with a proton pump inhibitor), and pancreatectomy (Viokace in combination with a proton pump inhibitor) |
| Pharmacodynamics | Used in the treatment of cystic fibrosis or pancreatic dysfunction, pancrelipase helps improve fat digestion in the small intestine. Specifically, the lipase, protease and amylase components break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. Pancreatic enzymes are used to correct maldigestion, malabsorption and pain associated with pancreatic insufficiency. The major maldigestion/malabsorption problems arise from incomplete fat digestion. Exogenous pancrelipase reduces the amount of nitrogen and fat excreted in the stool. |
| Mechanism of Action | The lipase, protease and amylase components of pancrelipase break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. |
| Toxicity | Overdose symptoms may include diarrhea or stomach upset. The most common adverse reactions seen are ear, neck, and abdominal pain; headache, nasal congestion, and beta-hemolytic streptococcal infection. |
| Metabolism | Pancrelipase acts locally, so there is minimal metabolism. |
| Absorption | Pancrelipase is not significantly absorbed from the gastrointestinal tract. |
| NA | |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Alimentary Tract and Metabolism, Carboxylic Ester Hydrolases, Complex Mixtures, Digestives, Incl. Enzymes, Enzyme Preparations, Enzymes, Enzymes and Coenzymes, Esterases, Gastrointestinal Agents, Hydrolases, Lipase, Pancreatic Extracts, Tissue Extracts |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | If pancrelipase and iron salts are used in combination then monitor therapy. Pancrelipase may decrease the absorption of iron salts except for ferumoxytol, iron dextran complex, and iron sucrose |
| Target | NA |
| Brand Name | Pancrecarb |
| Company | Digestive care US, Inc. |
| Brand Description | Digestive care US, Inc. |
| Prescribed For | PANCRECARB (pancrelipase) Delayed-Release Capsules, Buffered andEnteric-Coated Microspheres are indicated for patients with exocrinepancreatic enzyme insufficiency such as: cystic fibrosis, chronic pancreatitisdue to alcohol use or other causes, post-pancreatectomy and post-gastrointestinal bypass surgery |
| Chemical Name | NA |
| Formulation | it is formulated as Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres.It contains Lipase :4000 to 8000 U.S.P. units, Amylase: 25000 to 40000 U.S.P. units, Protease: 25000 to 45000 U.S.P. units.nactive ingredients include sodium carbonate, sodium bicarbonate, cellulose acetate phthalate, diethyl phthalate, gelatin, sodium carboxymethyl starch, polyvinylpyrrolidone, talc, ursodiol, and other trace ingredients. |
| Physical Appearance | Delayed-Release Capsules, Buffered and Enteric-Coated Microspheres. |
| Route of Administration | Oral route |
| Recommended Dosage | Dosage should be individualized and adjusted according to fat intake, severity of steatorrhea and the severity of the exocrine pancreatic insufficiency. Begin therapy with one or two capsules with meals or snacks and adjust dosage according to symptoms. |
| Contraindication | PANCRECARB (pancrelipase) Delayed-Release Capsules, Buffered andEnteric-Coated Microspheres are contraindicated in patients known to be hypersensitive to pork protein or any other ingredient of this product. |
| Side Effects | The most frequently reported adverse reactions to pancrelipase-containing products are gastrointestinal in nature, which may include nausea, vomiting, bloating, cramping, constipation or diarrhea. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenouspancreatic enzymes have been reported to be associated with hyperuricosuria and hyperuricemia. High strength pancrelipase preparation (i.e., those labeled as containing more than 20,000 lipase units per capsule) has been associated with colonic strictures. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 10423 |
| Therapeutic ID | Th1071 |
| Protein Name | Pancrelipase |
| Sequence | >Th1071_Pancrelipase QYSPNTQQGRTSIVHLFEWRWVDI |
| Molecular Weight | 131000 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 7.44 |
| Hydrophobicity | NA |
| Melting point | 48-50 |
| Half-life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so limination half-life is not relevant |
| Description | Pancrelipase is an enzyme mixture isolated from porcine or bovine pancreas, sometimes called pancreatin. It contains 3 enzymes: amylase, lipase, and a protease (chymotrypsin). Pancrelipase is marketed under several brand names such as Ultresa and Viokace. |
| Indication/Disease | For treatment of exocrine pancreatic insufficiency in cystic fibrosis (Ultresa), chronic pancreatitis (Viokace in combination with a proton pump inhibitor), and pancreatectomy (Viokace in combination with a proton pump inhibitor) |
| Pharmacodynamics | Used in the treatment of cystic fibrosis or pancreatic dysfunction, pancrelipase helps improve fat digestion in the small intestine. Specifically, the lipase, protease and amylase components break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. Pancreatic enzymes are used to correct maldigestion, malabsorption and pain associated with pancreatic insufficiency. The major maldigestion/malabsorption problems arise from incomplete fat digestion. Exogenous pancrelipase reduces the amount of nitrogen and fat excreted in the stool. |
| Mechanism of Action | The lipase, protease and amylase components of pancrelipase break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. |
| Toxicity | Overdose symptoms may include diarrhea or stomach upset. The most common adverse reactions seen are ear, neck, and abdominal pain; headache, nasal congestion, and beta-hemolytic streptococcal infection. |
| Metabolism | Pancrelipase acts locally, so there is minimal metabolism. |
| Absorption | Pancrelipase is not significantly absorbed from the gastrointestinal tract. |
| NA | |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Alimentary Tract and Metabolism, Carboxylic Ester Hydrolases, Complex Mixtures, Digestives, Incl. Enzymes, Enzyme Preparations, Enzymes, Enzymes and Coenzymes, Esterases, Gastrointestinal Agents, Hydrolases, Lipase, Pancreatic Extracts, Tissue Extracts |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | Viokace |
| Company | Aptalis Pharma US, Inc. |
| Brand Description | Aptalis Pharma US, Inc. |
| Prescribed For | VIOKACE (pancrelipase) tablets, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine paencratic insufficiencydue to chronic pancreatitis or pancreatectomy. |
| Chemical Name | NA |
| Formulation | 10,440 USP units of lipase; 39,150 USP units of protease; 39,150 USP units of amylase tablets are tan, round biconvex and have VIO9111 engraved on one side and 9111 on the other side.Inactive ingredients in VIOKACE include: colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc. |
| Physical Appearance | Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble in alcohol and converted to tablet form |
| Route of Administration | Oral route |
| Recommended Dosage | 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. |
| Contraindication | None |
| Side Effects | The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 10424 |
| Therapeutic ID | Th1071 |
| Protein Name | Pancrelipase |
| Sequence | >Th1071_Pancrelipase QYSPNTQQGRTSIVHLFEWRWVDI |
| Molecular Weight | 131000 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 8.44 |
| Hydrophobicity | NA |
| Melting point | 48-50 |
| Half-life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so limination half-life is not relevant |
| Description | Pancrelipase is an enzyme mixture isolated from porcine or bovine pancreas, sometimes called pancreatin. It contains 3 enzymes: amylase, lipase, and a protease (chymotrypsin). Pancrelipase is marketed under several brand names such as Ultresa and Viokace. |
| Indication/Disease | For treatment of exocrine pancreatic insufficiency in cystic fibrosis (Ultresa), chronic pancreatitis (Viokace in combination with a proton pump inhibitor), and pancreatectomy (Viokace in combination with a proton pump inhibitor) |
| Pharmacodynamics | Used in the treatment of cystic fibrosis or pancreatic dysfunction, pancrelipase helps improve fat digestion in the small intestine. Specifically, the lipase, protease and amylase components break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. Pancreatic enzymes are used to correct maldigestion, malabsorption and pain associated with pancreatic insufficiency. The major maldigestion/malabsorption problems arise from incomplete fat digestion. Exogenous pancrelipase reduces the amount of nitrogen and fat excreted in the stool. |
| Mechanism of Action | The lipase, protease and amylase components of pancrelipase break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. |
| Toxicity | Overdose symptoms may include diarrhea or stomach upset. The most common adverse reactions seen are ear, neck, and abdominal pain; headache, nasal congestion, and beta-hemolytic streptococcal infection. |
| Metabolism | Pancrelipase acts locally, so there is minimal metabolism. |
| Absorption | Pancrelipase is not significantly absorbed from the gastrointestinal tract. |
| NA | |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Alimentary Tract and Metabolism, Carboxylic Ester Hydrolases, Complex Mixtures, Digestives, Incl. Enzymes, Enzyme Preparations, Enzymes, Enzymes and Coenzymes, Esterases, Gastrointestinal Agents, Hydrolases, Lipase, Pancreatic Extracts, Tissue Extracts |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Synaptosomal-associated protein 25,Rho-related GTP-binding protein RhoB |
| Brand Name | ULTRESA |
| Company | Aptalis Pharma US, Inc. |
| Brand Description | Aptalis Pharma US, Inc. |
| Prescribed For | ULTRESA (pancrelipase) is indicated for the treatment of exocrinepancreatic insufficiency due to cystic fibrosis or other conditions. |
| Chemical Name | NA |
| Formulation | Each delayed-release capsule for oral administration contains enteric-coatedbeads (1.7 mm in diameter and 1.9 mm thick for 4,000 USP lipase units, approximately 2.0 mm in diameter and 2.0 – 2.4 mm thick for 13,800, 20,700, and 23,000 USP lipase units). it also contains colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate. |
| Physical Appearance | Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether and converted to Delayed-Release Capsules |
| Route of Administration | Oral route |
| Recommended Dosage | 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. |
| Contraindication | None |
| Side Effects | The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy,hyperuricemia and allergic reactions. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 10425 |
| Therapeutic ID | Th1071 |
| Protein Name | Pancrelipase |
| Sequence | >Th1071_Pancrelipase QYSPNTQQGRTSIVHLFEWRWVDI |
| Molecular Weight | 131000 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 9.44 |
| Hydrophobicity | NA |
| Melting point | 48-50 |
| Half-life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so limination half-life is not relevant |
| Description | Pancrelipase is an enzyme mixture isolated from porcine or bovine pancreas, sometimes called pancreatin. It contains 3 enzymes: amylase, lipase, and a protease (chymotrypsin). Pancrelipase is marketed under several brand names such as Ultresa and Viokace. |
| Indication/Disease | For treatment of exocrine pancreatic insufficiency in cystic fibrosis (Ultresa), chronic pancreatitis (Viokace in combination with a proton pump inhibitor), and pancreatectomy (Viokace in combination with a proton pump inhibitor) |
| Pharmacodynamics | Used in the treatment of cystic fibrosis or pancreatic dysfunction, pancrelipase helps improve fat digestion in the small intestine. Specifically, the lipase, protease and amylase components break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. Pancreatic enzymes are used to correct maldigestion, malabsorption and pain associated with pancreatic insufficiency. The major maldigestion/malabsorption problems arise from incomplete fat digestion. Exogenous pancrelipase reduces the amount of nitrogen and fat excreted in the stool. |
| Mechanism of Action | The lipase, protease and amylase components of pancrelipase break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. |
| Toxicity | Overdose symptoms may include diarrhea or stomach upset. The most common adverse reactions seen are ear, neck, and abdominal pain; headache, nasal congestion, and beta-hemolytic streptococcal infection. |
| Metabolism | Pancrelipase acts locally, so there is minimal metabolism. |
| Absorption | Pancrelipase is not significantly absorbed from the gastrointestinal tract. |
| NA | |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Alimentary Tract and Metabolism, Carboxylic Ester Hydrolases, Complex Mixtures, Digestives, Incl. Enzymes, Enzyme Preparations, Enzymes, Enzymes and Coenzymes, Esterases, Gastrointestinal Agents, Hydrolases, Lipase, Pancreatic Extracts, Tissue Extracts |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | PERTZYE |
| Company | Digestive care US, Inc. |
| Brand Description | Digestive care US, Inc. |
| Prescribed For | PERTZYE (pancrelipase) is indicated for the treatment of exocrinepancreatic insufficiency due to cystic fibrosis or other conditions. |
| Chemical Name | NA |
| Formulation | Each PERTZYE delayed-release capsule for oral administration contains bicarbonatebuffered enteric-coated microspheres ranging in size from 0.8 – 2.2 mm in diameter.8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase. it also contains odium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc and are contained in hard gelatin capsules. |
| Physical Appearance | Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether PERTZYE delayed-release capsule |
| Route of Administration | Oral route |
| Recommended Dosage | 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. |
| Contraindication | None |
| Side Effects | The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy,hyperuricemia and allergic reactions |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 10426 |
| Therapeutic ID | Th1071 |
| Protein Name | Pancrelipase |
| Sequence | >Th1071_Pancrelipase QYSPNTQQGRTSIVHLFEWRWVDI |
| Molecular Weight | 131000 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 10.44 |
| Hydrophobicity | NA |
| Melting point | 48-50 |
| Half-life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so limination half-life is not relevant |
| Description | Pancrelipase is an enzyme mixture isolated from porcine or bovine pancreas, sometimes called pancreatin. It contains 3 enzymes: amylase, lipase, and a protease (chymotrypsin). Pancrelipase is marketed under several brand names such as Ultresa and Viokace. |
| Indication/Disease | For treatment of exocrine pancreatic insufficiency in cystic fibrosis (Ultresa), chronic pancreatitis (Viokace in combination with a proton pump inhibitor), and pancreatectomy (Viokace in combination with a proton pump inhibitor) |
| Pharmacodynamics | Used in the treatment of cystic fibrosis or pancreatic dysfunction, pancrelipase helps improve fat digestion in the small intestine. Specifically, the lipase, protease and amylase components break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. Pancreatic enzymes are used to correct maldigestion, malabsorption and pain associated with pancreatic insufficiency. The major maldigestion/malabsorption problems arise from incomplete fat digestion. Exogenous pancrelipase reduces the amount of nitrogen and fat excreted in the stool. |
| Mechanism of Action | The lipase, protease and amylase components of pancrelipase break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. |
| Toxicity | Overdose symptoms may include diarrhea or stomach upset. The most common adverse reactions seen are ear, neck, and abdominal pain; headache, nasal congestion, and beta-hemolytic streptococcal infection. |
| Metabolism | Pancrelipase acts locally, so there is minimal metabolism. |
| Absorption | Pancrelipase is not significantly absorbed from the gastrointestinal tract. |
| NA | |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Alimentary Tract and Metabolism, Carboxylic Ester Hydrolases, Complex Mixtures, Digestives, Incl. Enzymes, Enzyme Preparations, Enzymes, Enzymes and Coenzymes, Esterases, Gastrointestinal Agents, Hydrolases, Lipase, Pancreatic Extracts, Tissue Extracts |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | ULTRASE |
| Company | Axcan Pharma |
| Brand Description | Axcan Pharma |
| Prescribed For | ULTRASE (pancrelipase) Capsules are indicated for patients with partial or complete exocrine pancreatic insufficiency caused by cystic fibrosis, Chronic pancreatitis due to alcohol, Obstruction, Other pancreatic disease, Poor mixing |
| Chemical Name | NA |
| Formulation | Each ULTRASE (pancrelipase) Capsule contains 4500 USP units of lipase; 25000 USP units of protease; 20000 USP units of amylase. It contains povidone, talc, sugar, methacrylic acid copolymer (Type C), triethyl citrate, simethicone emulsion. |
| Physical Appearance | Capsules Enteric-Coated Microspheres |
| Route of Administration | Oral route |
| Recommended Dosage | Initial dosing of pancreatic enzyme supplements should begin with 500 lipase U/kg/meal using enteric-coated microsphere products. |
| Contraindication | Pancrelipase capsules are contraindicated in patients known to be hypersensitive to pork protein. Pancrelipase capsules are contraindicated in patients with acute pancreatitis or with acute exacerbations of chronicpancreatic diseases. |
| Side Effects |  Extremely high doses of exogenouspancreatic enzymes have been associated with hyperuricosuria andhyperuricemia, |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 10427 |
| Therapeutic ID | Th1071 |
| Protein Name | Pancrelipase |
| Sequence | >Th1071_Pancrelipase QYSPNTQQGRTSIVHLFEWRWVDI |
| Molecular Weight | 131000 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 11.44 |
| Hydrophobicity | NA |
| Melting point | 48-50 |
| Half-life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so limination half-life is not relevant |
| Description | Pancrelipase is an enzyme mixture isolated from porcine or bovine pancreas, sometimes called pancreatin. It contains 3 enzymes: amylase, lipase, and a protease (chymotrypsin). Pancrelipase is marketed under several brand names such as Ultresa and Viokace. |
| Indication/Disease | For treatment of exocrine pancreatic insufficiency in cystic fibrosis (Ultresa), chronic pancreatitis (Viokace in combination with a proton pump inhibitor), and pancreatectomy (Viokace in combination with a proton pump inhibitor) |
| Pharmacodynamics | Used in the treatment of cystic fibrosis or pancreatic dysfunction, pancrelipase helps improve fat digestion in the small intestine. Specifically, the lipase, protease and amylase components break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. Pancreatic enzymes are used to correct maldigestion, malabsorption and pain associated with pancreatic insufficiency. The major maldigestion/malabsorption problems arise from incomplete fat digestion. Exogenous pancrelipase reduces the amount of nitrogen and fat excreted in the stool. |
| Mechanism of Action | The lipase, protease and amylase components of pancrelipase break down fat, protein, and starches, respectively, in the small intestine. Lipase hydrolyzes fats into glycerol and fatty acids. Protease converts proteins into proteoses and derived substances, while amylase converts starches into dextrins and sugars. |
| Toxicity | Overdose symptoms may include diarrhea or stomach upset. The most common adverse reactions seen are ear, neck, and abdominal pain; headache, nasal congestion, and beta-hemolytic streptococcal infection. |
| Metabolism | Pancrelipase acts locally, so there is minimal metabolism. |
| Absorption | Pancrelipase is not significantly absorbed from the gastrointestinal tract. |
| NA | |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Alimentary Tract and Metabolism, Carboxylic Ester Hydrolases, Complex Mixtures, Digestives, Incl. Enzymes, Enzyme Preparations, Enzymes, Enzymes and Coenzymes, Esterases, Gastrointestinal Agents, Hydrolases, Lipase, Pancreatic Extracts, Tissue Extracts |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Dietary fat,Dietary protein,Dietary starch |
| Brand Name | ZENPEP |
| Company | Aptalis Pharma US, Inc. |
| Brand Description | Aptalis Pharma US, Inc. |
| Prescribed For | ZENPEP (pancrelipase) is indicated for the treatment of exocrinepancreatic insufficiency due to cystic fibrosis or other conditions. |
| Chemical Name | NA |
| Formulation | Each capsule for oral administration contains enteric-coated beads (1.8-1.9mm for 3,000 and 5,000 USP units of lipase, 2.2-2.5mm for 10,000, 15,000, 20,000, 25,000, and 40,000 USP units of lipase). ZENPEP include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate and are contained in hypromellose capsules. The imprinting red ink on the 3,000 capsules strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin. |
| Physical Appearance | Delayed-Release Capsules |
| Route of Administration | Oral route |
| Recommended Dosage | 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. |
| Contraindication | None |
| Side Effects | The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy,hyperuricemia and allergic reactions |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |