{"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 hyperuricosuria, 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 the carcinogenic potential."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The natural digestive enzymes in PANOKASE ® 16 hydrolyze fats into fatty acids and glycerol, split protein into amino acids, and convert carbohydrates 10 dextrins and short chain sugars. Under conditions of the USP test method (in vitro) PANOKASE ® 16 has the following total digestive capacity: Dietary fat, grams ...................... 56 Dietary protein, grams................. 60 Dietary starch, grams .................. 60 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 Should not be used in patients hypersensitive to pork protein."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION PANOKASE ® 16 (pancrelipase, USP) is a pancreatic enzyme concentrate of porcine origin containing standardized lipase, protease, and amylase as well as other pancreatic enzymes, PANOKASE ® 16 is available in tablet form for oral administration The enzyme potencies of the tablets are: Lipase, USP Units 16,000 Protease USP Units 60,000 Amylase USP Units 60,000 Inactive Ingredients: Stearic acid lactose, anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Dosage range for patients with cystic fibrosis or chronic pancreatitis is from 8,000 to 32,000 Lipase USP Units taken with meals, i,e., one to two tablets with meals or as directed by a physician. In patients with pancreatectomy or obstruction of pancreatic ducts: One tablet taken at 2-hour intervals or as directed by a 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":"20110318","general_precautions":["General Individuals previously sensitized to trypsin, pancreatin or pancrellipase may have allergic manifestations."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED PANOKASE ® 16 Tablets are supplied as tan, oval tablets debossed B 654 on one side in bottles of 100 (NDC 51991-654-01) and 500 (NDC 5199-654-05). Store in tightly closed container in a dry place at a temperature not exceeding 25 o C (77 o F) Dispense tablets in tight, light-resistant container as defined in USP/NF with child-resistant closure preferably with a dessicant -All prescription substitutions using this product shall be pursuant to state statutes as applicable This is not an Orange Book product"],"id":"b6372ca3-dba7-48f7-9661-341e533bacad","indications_and_usage":["INDICATIONS AND USAGE PANOKASE ® 16 (pancrelipase, USP) is indicated in the treatment of exocrine pancreatic insufficiency as associated with but not limited to cystic fibrosis, chronic pancreatitis, pancreatectomy or obstruction of the pancreatic ducts."],"information_for_patients":["Information for Patients PANOKASE ® 16 should not be held in the mouth as the proteolytic 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. Because many drugs are excreted in human milk, caution should be exercised when pancrelipase 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 tests rats developed swollen salivary glands, This is believed due to the proteolytic activity and the mucosal irritation caused by tissue digestion. No acute toxic reactions have been reported."],"package_label_principal_display_panel":["PRINCIPLE DISPLAY PANEL CONTAINER LABEL 6650 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS General Individuals previously sensitized to trypsin, pancreatin or pancrellipase may have allergic manifestations. Information for Patients PANOKASE ® 16 should not be held in the mouth as the proteolytic 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 the carcinogenic potential. Pregnancy Category C: Animal reproduction studies have not been conducted with PANOKASE ® 16. It is also not known whether PANOKASE ® 16 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PANOKASE ® 16 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. Because many drugs are excreted in human milk, caution should be exercised when pancrelipase is administered to a nursing mother. Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with PANOKASE ® 16. It is also not known whether PANOKASE ® 16 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PANOKASE ® 16 should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"b6372ca3-dba7-48f7-9661-341e533bacad","spl_product_data_elements":["PANOKASE 16 PANCRELIPASE PANCRELIPASE LIPASE PANCRELIPASE LIPASE PANCRELIPASE AMYLASE PANCRELIPASE AMYLASE ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE ANHYDROUS LACTOSE SILICON DIOXIDE STEARIC ACID CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE B;654"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}