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Ultrase MT

Last reviewed on RxList: 6/2/2017
Ultrase MT Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/8/2016

Ultrase MT (pancrelipase) is a combination of three enzymes (proteins): lipase, protease, and amylase, used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts. Ultrase MT may also be used following surgical removal of the pancreas. This medication may be available in generic form. Common side effects of Ultrase MT include:

  • diarrhea
  • constipation
  • abdominal pain
  • stomach upset
  • cramps
  • dizziness
  • nausea
  • vomiting
  • bloating
  • gas
  • greasy stools
  • rectal irritation
  • headache
  • cough, or
  • weight loss

Dosage of Ultrase MT is adjusted according to the severity of the exocrine pancreatic insufficiency. The usual starting dose is one or two capsules with meals or snacks, adjusted according to symptoms. Ultrase MT may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ultrase MT should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Ultrase MT (pancrelipase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ultrase MT Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas;
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ultrase MT (Pancrelipase Capsules)

Ultrase MT Professional Information

SIDE EFFECTS

The most frequently reported adverse reactions to products containing pancrelipase 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 two clinical studies with ULTRASE® MT (pancrelipase capsules) 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.10 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.11 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.12

"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.

  1. In whom should one consider the diagnosis of fibrosing colonopathy?
    1. Patients with cystic fibrosis who have evidence of partial or complete obstruction, bloody diarrhea or chylous ascites.
    2. Patients who have two of the following three symptoms:

      ESPECIALLY if they have:

      • taken > 6,000 lipase U/kg/meal
      • age less than twelve years
      • history of meconium ileus
      • prior intestinal surgery
      • history of recurrent DIOS
      • "inflammatory bowel disease"13

Read the entire FDA prescribing information for Ultrase MT (Pancrelipase Capsules)

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© Ultrase MT Patient Information is supplied by Cerner Multum, Inc. and Ultrase MT Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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