Action And Clinical Pharmacology: Pancrelipase capsules are designed to prevent inactivation by gastric acid thereby resulting in the delivery of predictable, high levels of biologically active enzymes into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, starch into dextrins and sugars, and protein into proteoses and derived substances.
Indications And Clinical Uses: For patients with partial or complete exocrine pancreatic insufficiency such as: cystic fibrosis, chronic pancreatitis, postpancreatectomy, postgastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy), and ductal obstruction from neoplasm (e.g., of the pancreas or common bile duct).
Pancrelipase capsules are effective in controlling steatorrhea.
Contra-Indications: In patients known to be hypersensitive to pork protein.
Pancrelipase capsules are contraindicated in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases.
Manufacturers’ Warnings In Clinical States: Should hypersensitivity occur, discontinue medication and treat symptomatically.
Precautions: General: To protect enteric coating, minitablets or microspheres must not be crushed or chewed. Where swallowing of capsules is difficult, they may be opened and the minitablets or microspheres added to a small quantity of a soft food (e.g., applesauce, gelatin, etc.), which does not require chewing, and swallowed immediately. Contact of the minitablet with foods having a pH greater than 5.5 can dissolve the protective enteric shell.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential. Methacrylic acid, a minor component of the methacrylic acid copolymer enteric-coating contained in Ultrase MT capsules, has been reported to act as a teratogen in rat embryo cultures. However, Ultrase MT capsules have been shown to contain
The copolymer enteric-coating of Ultrase MT capsules was not mutagenic by the Ames test, and it did not produce chromosome damage in a test for unscheduled DNA synthesis in rat hepatocytes.
Pregnancy: Category C: Animal reproduction studies have not been conducted with pancrelipase. It is not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pancrelipase should be given to a pregnant woman only if the potential benefit outweighs the potential risk to the fetus.
Lactation: It is not known whether pancrelipase 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.
Adverse Reactions: The most frequently reported adverse reactions to pancrelipase-containing products are gastrointestinal in nature. Less frequently, allergic-type reactions have also been observed.
Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricemia when the preparations given were pancrelipase in powdered or capsule form, or pancreatin in tablet form.
In 2 clinical studies with Ultrase MT in 193 patients with cystic fibrosis, the adverse events described were all gastrointestinal in nature and may actually represent symptoms of the underlying disease, such as abdominal pain/cramps (5.7%), diarrhea (3.6%), and greasy stools and flatulence (1.5% each). In a postmarketing trial with another enteric-coated formulation, 160 adverse events occurred in the 15 711 patients (0.97%) evaluated. The most frequent events reported were diarrhea, skin reaction, and abdominal discomfort (0.2% each).
Colonic strictures have been reported in cystic fibrosis patients treated with both high- and lower-strength enzyme supplements. A causal relationship has not been established. The possibility of bowel stricture should be considered if symptoms suggestive of gastrointestinal obstruction occur. Since impaired fluid secretion may be a factor in the development of intestinal obstruction, care should be taken to maintain adequate hydration, particularly in warm weather.
“Fibrosing colonopathy” is a term used to describe a condition seen in patients with CF who have taken high amounts of pancreatic enzyme supplements (>6 000 lipase U/kg/meal). At its most advanced, this condition leads to colonic strictures.
Dosage And Administration: The enzymatic activity of pancrelipase is expressed in USP units. Each capsule contains the labeled amount of lipase activity and an overage of not more than 25%.
The smallest effective dose should be used. Dosage should be adjusted according to the severity of the exocrine pancreatic insufficiency. Begin therapy with 1 or 2 capsules with meals or snacks and adjust dosage according to symptoms. The number of capsules or capsule strength given with meals and/or snacks should be estimated by assessing which dose minimizes steatorrhea and maintains good nutritional status.
Dosages should be adjusted according to the response of the patient. Where swallowing of capsules is difficult, they may be opened and the minitablets or microspheres added to a small quantity of a soft food (e.g., applesauce, gelatin, etc.), which does not require chewing, and swallowed immediately.
It is recommended that the total dose of pancrelipase being ingested for a meal or snack be dispersed equally (with fluids) before, during, and after the meal or snack.
Availability And Storage: Ultrase: Each opaque white and opaque white capsule, printed “ULTRASE” and “MS 4” of enteric-coated microspheres contains: lipase 4 500 USP units, amylase 20 000 USP units and protease 25 000 USP units. Nonmedicinal ingredients: Eudragit L30D, neutral pellets, pancreatin, povidone, simethicone emulsion, talc and triethylcitrate. Bottles of 100.
Ultrase MT 12: Each white and yellow capsule, printed “ULTRASE” and “MT 12” of enteric-coated minitablets, contains: lipase 12 000 USP units, amylase 39 000 USP units and protease 39 000 USP units. Nomedicinal ingredients: cellulose microcrystalline, hydrogenated castor oil, iron oxides, magnesium stearate, silicone dioxide, simethicone, sodium carboxymethylcellulose, talc, titanium oxide, triethylcitrate and USP methacrylic acid copolymer (type C). Bottles of 100.
Ultrase MT 20: Each light grey and yellow capsule, printed “ULTRASE” and “MT 20” of enteric-coated minitablets, contains: lipase 20 000 USP units, amylase 65 000 USP units and protease 65 000 USP units. Nomedicinal ingredients: cellulose microcrystalline, hydrogenated castor oil, iron oxides, magnesium stearate, silicone dioxide, simethicone, sodium carboxymethylcellulose, talc, titanium oxide, triethylcitrate and USP methacrylic acid copolymer (type C). Bottles of 100.
ULTRASE® MT Axcan Pharma Pancrelipase Digestive Enzymes
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