Ultresa

Ultresa is a prescription medication used to improve digestion in people who do not have enough pancreatic enzymes due to cystic fibrosis, pancreatitis, or other conditions.

Ultresa belongs to a group of drugs called pancreatic enzymes. These replace digestive enzymes that are normally produced by the pancreas.

This medication comes in delayed-release capsule form and is taken with meals.

Do not chew, divide, or break Ultresa capsules. Swallow Ultresa whole.

Common side effects of Ultresa include headache, throat pain, and nosebleeds.

Ultresa is a prescription medication used to improve digestion in people who do not have enough pancreatic enzymes due to cystic fibrosis, pancreatitis, or other conditions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your diet
• your weight
• your age

The dose of Ultresa varies with your age, body weight, and the amount of fat in your diet. Do not exceed maximum daily dosage recommendations.

Serious side effects have been reported with Ultresa including the following:

• Fibrosing colonopathy. Tell your healthcare provider right away if you have some or all of the following symptoms of fibrosing colonopathy:
  • stomach pain
  • bloating
  • trouble having bowel movements
  • severe nausea, vomiting, or diarrhea
• Irritation to oral mucosa. This can happen if Ultresa capsules are not swallowed completely.
• Increased risk of high levels of uric acid. Ultresa may cause worsening of swollen, painful joints. Caution should be exercised in patients with gout, kidney disease, or already high levels of uric acid in the blood.
• Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:
  • trouble breathing
  • hives
  • itching

Do not take Ultresa if you are allergic to Ultresa or to any of its ingredients.

Serious side effects have been reported with Ultresa. See the “Ultresa Precautions” section.

Common side effects of Ultresa include the following:

• headache
• cough
• sore throat
• neck pain
• dizziness
• nosebleed
• feeling full after eating a small amount
• heartburn
• constipation
• gas
• irritation around the anus
• sore mouth or tongue

This is not a complete list of Ultresa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No Ultresa drug interactions have been identified by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ultresa falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Ultresa should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ultresa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ultresa.