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Ultresa Warnings and Precautions

People who have kidney disease or a history of certain bowel problems may not be able to safely use Ultresa. There are also some safety precautions for people who have high uric acid in the blood, as well as warnings for those who have gout. Some people may also have an increased risk for developing problems like allergic reactions and other dangerous complications.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Ultresa® (pancrelipase) if you have:
 
  • Trouble swallowing capsules
  • Kidney disease, such as kidney failure, or if you are on dialysis
  • A history of intestinal blockage or other bowel problems
  • High uric acid in the blood (hyperuricemia)
  • Gout
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings for Ultresa

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Ultresa may increase uric acid levels in the blood, which may cause or worsen gout or kidney problems.
 
  • Make sure to swallow Ultresa capsules whole or, for young children or other individuals with difficulty swallowing capsules, sprinkled on a cold, slightly acidic food (like applesauce or yogurt). Do not chew the capsules or the contents of the capsules. The small pellets in the capsules have a coating that helps protect the mouth from the drug, which can be quite irritating.
 
  • For people opening the capsules and sprinkling on food, always follow the dosage with juice or water. If mouth irritation occurs, let your healthcare provider know.
 
  • As with other pancrelipase products, Ultresa can cause a condition known as fibrosing colonopathy. This condition is potentially serious and may require surgery. It is most likely to occur with very high doses of Ultresa. Alert your healthcare provider to any symptoms of this condition, such as unusual or severe:
    • Abdominal (stomach) pain
    • Bloating
    • Trouble passing stool
    • Nausea, vomiting, or diarrhea.
 
  • Ultresa is derived from the pancreatic glands in pigs. There is a theoretical possibility that the medication could contain viruses or other infectious materials from the pigs, although measures are taken to help prevent this. No cases of pig-related infections from Ultresa have ever been reported.
 
  • People who are allergic to pigs or pig products might also be allergic to Ultresa. As is possible with many medications that suppress the immune system, it is possible that Ultresa might increase the risk for certain cancers. Discuss this risk with your healthcare provider, especially if you have a history of any type of cancer.
   
  • Ultresa is a pregnancy Category C medication, which means it may not be safe for use in pregnant women, although the full risks are currently unknown (see Ultresa and Pregnancy).
 
  • It is unknown whether Ultresa passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Ultresa and Breastfeeding).
 

Ultresa Medication Information

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