Ultrase
Ultrase Medication Information:
Ultrase medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.
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Ultrase 39-12-39
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Ultrase 65-20-65
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Pharmacology
ULTRASE and ULTRASE MT (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
For patients with partial or complete exocrine pancreatic insufficiency such as: cystic fibrosis, chronic pancreatitis, post-pancreatectomy, post-gastrointestinal 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.
Precautions
Lactation
It is not known whether ULTRASE and ULTRASE MT (pancrelipase) capsules are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ULTRASE and ULTRASE MT (pancrelipase) capsules are administered to a nursing mother.
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 capsules, has been reported to act as a teratogen in rat embryo cultures. However, ULTRASE capsules have been shown to contain <0.001% of methacrylic acid, and the mammalian teratology studies in the rat and rabbit were negative.
The copolymer enteric-coating of ULTRASE 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.
General
Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations.
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.), that does not require chewing, and swallowed immediately. Contact of the minitablets or microspheres with foods having a pH greater than 5.5 can dissolve the protective enteric shell.
Pregnancy
Animal reproduction studies have not been conducted with ULTRASE and ULTRASE MT (pancrelipase) capsules. It is not known whether ULTRASE and ULTRASE MT (pancrelipase) capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ULTRASE and ULTRASE MT (pancrelipase) capsules should be given to a pregnant woman only if the potential benefit outweighs the potential risk to the fetus.
Supplied
ULTRASE
Each opaque white capsule, printed “ULTRASE” and “MS 4” of enteric-coated microspheres contains: lipase 4500 USP units, amylase 20 000 USP units and protease 25 000 USP units. Nonmedicinal ingredients: methacrylic acid copolymer (Type C), povidone, simethicone emulsion, sugar, talc and triethyl citrate. Bottles of 100.
ULTRASE MT12
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. Nonmedicinal ingredients: croscarmellose sodium, gelatin, hydrogenated castor oil, hydroxypropyl methylcellulose pthalate (HP55) (as dry substance), iron oxides, magnesium stearate, microcrystalline cellulose, silicone dioxide, talc, titanium dioxide and triethyl citrate. Bottles of 100.
ULTRASE MT20
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. Nonmedicinal ingredients: croscarmellose sodium, gelatin, hydrogenated castor oil, hydroxypropyl methylcellulose pthalate (HP55) (as dry substance), iron oxides, magnesium stearate, microcrystalline cellulose, silicone dioxide, talc, titanium dioxide and triethyl citrate. Bottles of 100.
Keep bottle tightly closed. Store at controlled room temperature (15-25°C) in a safe, dry place. Do not refrigerate. Dispense in a tight container.
Contraindications
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.
Warnings
Should hypersensitivity occur, discontinue medication and treat symptomatically.
Adverse Effects
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%). 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 (>6000 lipase U/kg/meal). At its most advanced, this condition leads to colonic strictures.
Overdose
For management of a suspected drug overdose, CPhA recommends that you contact your regional Poison Control Centre. See the eCPS Directories section for a list of Poison Control Centres.
No data supplied by the manufacturer.
Dosage
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.
