Apriso

Apriso is a prescription medication used to treat ulcerative colitis, or inflammation of the lining of the colon. It helps relieve the symptoms of ulcerative colitis including diarrhea, rectal bleeding, and stomach pain. Apriso belongs to a group of drugs called aminosalicylates. These work by stopping the body from producing a certain substance that may cause pain or inflammation in the colon.

Apriso comes in extended-release capsules and are usually taken once a day in the morning, with or without food.

Common side effects of Apriso include headache, diarrhea, and stomach pain.

Apriso is a prescription medication used to treat ulcerative colitis (UC). UC is a condition in which part or all of the lining of the colon (also known as the large intestine) is swollen or worn away. It is used to keep it from coming back ("maintain remission").

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

• Salix Pharmaceuticals, Inc.

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

Common side effects of Apriso include:

• headache
• abdominal pain
• diarrhea
• nausea
• runny nose
• sneezing
• flu or flu-like illness

Other less common side effects include:

• abnormal liver function tests
• hair loss
• itching
• upset stomach
• back pain
• rash
• joint pain
• fatigue
• high bloos pressure

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

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines that can damage the kidneys, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• azathioprine (Imuran)
• 6-mercaptopurine (Purinethol)
• antacids such as Maalox, Mylanta, Mag-Ox, Caltrate, Tums, or Rolaids

This is not a complete list of Apriso drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Apriso including:

• Kidney problems. Tell your doctor if you take non-steroidal anti-inflammatory drugs or have kidney disease. Your doctor will check your kidney function with a simple blood test before you start taking Apriso.
• Apriso may worsen ulcerative colitis. Tell your doctor if you experience the following symptoms:
  • cramping
  • acute abdominal pain
  • bloody diarrhea
  • fever
  • headache
  • rash
• Hypersensitivity reaction. An allergic reaction is possible with Apriso. Tell your doctor if you are allergic to sulfasalazine (Azulfidine) or Apriso. Serious reactions can lead to heart problems, like myocarditis or pericarditis.
• Liver failure is possible with Apriso. Tell your doctor if you have liver disease.
• Upper GI tract obstruction. Pyloric stenosis or an obstruction in the digestive tract could prevent Apriso from reaching the colon and treating ulcerative colitis.
• Pericarditis (inflammation of the lining around the heart). Tell your doctor if you experience symptoms of pericarditis including chest pain, rapid heartbeat, difficulty breathing, and fever. Your doctor may want to temporarily stop use of Apriso.

Intact, partially intact, and/or capsule shells have been reported in the stool. Contact your doctor if this occurs repeatedly.

Do not take Apriso if you:

• have kidney disease
• are allergic to mesalamine or any ingredients in Apriso
• are allergic to salicylates (including aspirin)

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Apriso, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Apriso, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• have had an allergic reaction to sulfasalazine (Azulfidine), salicylates (such as aspirin), or Apriso
• are taking nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil) and aspirin (Ecotrin) or other drugs that affect the kidneys
• are taking azathioprine (Imuran) or 6-mercaptopurine (Purinethol)
• have cramping, abdominal pain, bloody diarrhea, fevers, headaches, or rashes
• have a history of myocarditis or pericarditis
• have had inflamed pancreas (pancreatitis)
• are allergic to other things, such as foods, preservatives, or dyes
• have kidney, liver, or heart disease
• have a history of stomach blockage
• have phenylketonuria (PKU). Apriso capsule contains aspartame equivalent to 0.56 mg of phenylalanine
• repeatedly see intact, partially intact, and/or capsule shells in the stool
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescriptions medicines, vitamins, and herbal supplements.

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.

Apriso falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Apriso is excreted in human breast milk. The effect of Apriso on the nursing infant is not known.

Take Apriso exactly as prescribed. Do not change the dose or stop taking Apriso without talking to your doctor.

Apriso comes in extended-release capsules and are usually taken once a day in the morning, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Apriso at the same time.

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

• Apriso (mesalamine extended release capsules)
  •  4 capsules once daily (1.5 grams/day) in the morning with or without food

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Apriso at 20° to 25°C (68° to 77°F).
• Keep this and all medicines out of the reach of children.