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home > drugs a-z list > ultrase (pancrelipase) drug center > ultrase (pancrelipase) drug - warnings and precautions
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Ultrase
Pancreatitis facts*
*Pancreatitis facts Medically Edited by: Charles P. Davis, MD, PhD
- Pancreatitis is inflammation of the pancreas, the organ that secretes digestive enzymes into the gastrointestinal tract; it also synthesizes and secretes insulin and glucagon.
- Pancreatitis may be caused by gallstones (by blocking the pancreatic duct outlet), chronic alcohol use, trauma, medications, infections, tumors, and genetic abnormalities.
- Acute pancreatitis with upper abdominal pain that is often severe and constant over several days, and may be accompanied by fever, nausea, vomiting, tachycardia, and abdominal swelling; severe cases can develop dehydration, low blood pressure, shock, organ failure, and death.
- Acute pancreatitis is diagnosed preliminarily by the patient's history, physical exam and the levels of amylase and lipase in the blood (elevated in pancreatitis patients); other t...
Ultrase
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PRECAUTIONS
General
TO PROTECT ENTERIC COATING, MICROSPHERES MUST NOT BE CRUSHED OR CHEWED. Where swallowing of capsules is difficult, they may be opened and the 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 microsphere 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® (pancrelipase) Capsules, has been reported to act as a teratogen in rat embryo cultures. However, the copolymer enteric-coating of ULTRASE® (pancrelipase) 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 ULTRASE® (pancrelipase) Capsules. It is not known whether ULTRASE® (pancrelipase) Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ULTRASE® (pancrelipase) Capsules should be given to a pregnant woman only if the potential benefit outweighs the potential risk to the fetus.
Nursing Mothers
It is not known whether ULTRASE® (pancrelipase) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ULTRASE® (pancrelipase) Capsules are administered to a nursing mother.
Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.
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