{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS The dust or finely powdered pancreatic enzyme concentrate is irritating to the nasal mucosa and the respiratory tract. It has been documented that inhalation of the airborne powder can precipitate an asthma attack. The literature also contains several references to asthma due to inhalation in patients sensitized to pancreatic enzyme concentrates. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricemia and hyperurlcosuria. Overdosage of pancreatic enzyme concentrate may cause diarrhea or transient intestinal upset."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The natural digestive enzymes hydrolyze fats into tatty acids and glycerol, split protein into amino acids, and convert carbohydrates to dextrins and short chain sugars. Under conditions of the USP test method (in vitro) each tablet has the following total digestive capacity: Dietary Fat, grams ................................................................ 28 Dietary Protein, grams ......................................................... 30 Dietary Starch, grams .......................................................... 30 These tablets are immediate release and are not enteric coated. The digestive capacity of a pancreatic enzyme concentrate depends on the amount that passes through the stomach unchanged and is available at the site of action in the small intestine."],"contraindications":["CONTRAINDICATIONS Do not use in patients hypersensitive to pork protein."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Pancrelipase, USP is a pancreatic enzyme concentrate of porcine origin containing standardized lipase, protease, and amylase as well as other pancreatic enzymes. This is available in tablet form for oral administration. Each tablet contains: Lipase, USP Units ................................................................ 8,000 Protease, USP Units ............................................................. 30,000 Amylase, USP Units ............................................................ 30,000 Inactive ingredients: Lactose, Steric Acid, Sodium Chloride."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Dosage for patients with cystic fibrosis or chronic pancreatitis - one to four tablets (8,000 to 32,000 Lipase) with meals or as directed by physician. As a digestive aid in patients with pancreatoctomy or obstruction of pancreatic ducts - 1 to 2 tablets taken at 2-hour intervals or as directed by physician. Warning: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions Drug/Laboratory Test Interactions","Drug Interactions"],"effective_time":"20110317","general_precautions":["General Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Pancrelipase Tablets USP are roun shaped, off white, and scored. Each tablet is debossed with th logo \"EL | 20\" on the scored side and plain on the other. Pancrelipase Tablets, USP are supplied in bottles of 100s (NDC 0904-3472-60) and 500s (NDC 0904-3472-10). Store in a tightly closed container in a dry place at a temperature not exceeding 25 o C (77 o F). Dispense tablets in tight, light-light resistant container as defined in the USP/NF with a child-resistant closure, preferably with a desiccant. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"id":"dea9f2ba-a8f4-4a30-9dc1-f688f98eac4a","indications_and_usage":["INDICATIONS AND USAGE Pancrelipase is indicated as a digestive aid in the treatment of exocrine pancreatic insufficiency as associated with but not limited to cystic fibrosis, chronic pancreatitis, pancreatectomy, or obstruction of pancreatic ducts."],"information_for_patients":["Information for Patients These tablets should not be held in the mouth as the proteclytic action may cause irritation of the mucosa."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when this drug is administered to a nursing mother."],"openfda":{},"overdosage":["OVERDOSAGE Acute toxicity determinations in animals have not been possible since the maximum dose that could be given orally produced no toxic reaction. In chronic feeding test, rats developed swollen salivary glands. This is believed due to the proteolytic activity and the mucosal irritation caused by tissue digestion."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6089 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS General Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations. Information for Patients These tablets should not be held in the mouth as the proteclytic action may cause irritation of the mucosa. Laboratory Tests Interactions Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy Category C: Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnat woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when this drug is administered to a nursing mother. Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnat woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"dea9f2ba-a8f4-4a30-9dc1-f688f98eac4a","spl_product_data_elements":["PANCRELIPASE PANCRELIPASE PANCRELIPASE LIPASE PANCRELIPASE LIPASE PANCRELIPASE AMYLASE PANCRELIPASE AMYLASE PANCRELIPASE PROTEASE PANCRELIPASE PROTEASE SODIUM CHLORIDE ANHYDROUS LACTOSE LACTOSE STEARIC ACID WHITE POWDER EL;20"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}