A database of FDA approved therapeutic peptides and proteins
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1422 details |
| Primary information | |
|---|---|
| ThPP ID | Th1071 |
| Therapeutic Peptide/Protein Name | Pancrelipase |
| Sequence | Pancreatic alpha amylase: QYSPNTQQGRTSIVHLFEWRWVDI view full sequnce in fasta |
| Functional Classification | Ia |
| Molecular Weight | 131125.6 |
| Chemical Formula | C5850H8902N1606O1739S49 |
| Isoelectric Point | 6.44 |
| Hydrophobicity | N.A. |
| Melting Point (℃) | 48-50 |
| Half Life | Pancrelipase is not significantly absorbed from the gastrointestinal tract and acts locally, so ther |
| 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. |
| Volume of Distribution | N.A. |
| Clearance | Pancrelipase is not significantly absorbed, so there is minimal clearance from the body. |
| Categories | Gastrointestinal Agents and Enzyme Replacement Agents |
| Patents Number | N.A. |
| Date of Issue | N.A. |
| Date of Expiry | N.A. |
| 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 | N.A. |
| Information of corresponding available drug in the market | |
| Brand Name | Pancrecarb |
| Company | Digestive care US, Inc. |
| Brand Discription | PANCRECARB (pancrelipase) contain buffered pancreatic enzymes: lipase,amylase and protease, isolated and concentrated from porcine pancreatic glands. The enzyme containing microspheres are coated with a pH sensitive enteric-coating to provide protection against gastric inactivation of the buffer-stabilized enzymes during gastric passage. |
| 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 | N.A. |
| 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. |
| Physcial Appearnce | 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 | http://www.rxlist.com/pancrecarb-drug.htm |
| PubMed ID | 28099252, 27560634, 26748629, 26726093, 26709820, 26495784, 26495776, 26150571, 26036459 |
| 3-D Structure | Th1071 (View) or (Download) |