Apriso

Generic name: Mesalamine (oral)
Drug class: 5-aminosalicylates

Usage of Apriso

Apriso affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Apriso is used to treat mild to moderate ulcerative colitis in patients 18 years of age and older.

Apriso is used to prevent the symptoms of ulcerative colitis from recurring.

Apriso side effects

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

Stop using Apriso and call your doctor at once if you have:

  • severe stomach pain, stomach cramping, bloody diarrhea;
  • fever, headache, general ill feeling;
  • rash, itching, eye redness;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
  • signs of a kidney stone - severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;
  • kidney problems - increased or decreased urination, swelling, weight gain; or
  • liver problems - loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

    • Low white blood cell counts may be more likely in older adults.

    Common Apriso side effects may include:

  • burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;
  • dizziness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • back pain;
  • headache;
  • rash; or
  • abnormal liver function tests.

    • 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.

    Before taking Apriso

    You should not use Apriso if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

    To make sure Apriso is safe for you, tell your doctor if you have ever had:

  • a kidney stone or kidney disease;
  • liver disease;
  • a blockage in your stomach or intestines (such as pyloric stenosis); or
  • a skin condition such as eczema.

    • Apriso capsules contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

    Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

    It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

    Do not give this medicine to a child. Apriso is not approved for use in anyone younger than 18 years old.

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    How to use Apriso

    Usual Adult Dose for Ulcerative Colitis -- Maintenance:

    Apriso 375 mg extended release capsules: 1.5 g (4 capsules) orally once a day in the morning Comments: Do not co-administer Apriso 375 mg extended release capsules with antacids. Use: Maintenance of remission of ulcerative colitis in adults.

    Warnings

    Stop using Apriso and call your doctor at once if you have severe stomach pain, stomach cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

    What other drugs will affect Apriso

    Apriso can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

    Tell your doctor about all your other medicines, especially:

  • azathioprine or 6-mercaptopurine.

    • This list is not complete. Other drugs may interact with mesalamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Popular FAQ

    Research studies looking at patients who received daily oral doses of 4 to 6 grams of mesalamine showed that 80% of patients achieved complete or significant clinical improvement within 4 weeks.

    Mesalamine is an antiinflammatory, not an immunosuppressant. It may be one of the first treatments used for ulcerative colitis (UC) to lessen symptoms like diarrhea, rectal bleeding, or stomach pain. Immunosuppression is not a listed side effect for mesalamine. Other medicines used for UC, like prednisone, can suppress the immune system.

    The best time to take or use mesalamine will depend on the specific product you are using and why you are using it (ulcerative colitis induction or maintenance, ulcerative proctitis). Some products may need to be taken with food while others are taken on an empty stomach. Check with your doctor.

    Some forms of mesalamine are used long-term as a maintenance therapy in ulcerative colitis to help prevent symptoms from flaring up. Not all forms or brands of mesalamine are used long-term, so check with your doctor about your specific medicine. Call your doctor if your ulcerative colitis symptoms get worse after starting treatment.

    Brand name products of mesalamine may be more expensive than generic options. Some, but not all mesalamine products are available as generics. Your insurance should help pay for generics, or if you are paying out-of-pocket, ask your healthcare provider if there is a more affordable option.

    Mesalamine is available as delayed-release tablets or capsules, extended-release capsules, and rectal preparations like suppositories or enemas. The maximum dose will depend upon the specific product you are using and your diagnosis. Only use the dose prescribed by your doctor.

    Mesalamine is used in some patients with ulcerative colitis as a maintenance (long-term) treatment to help you stay in remission (without active symptoms). Other treatments for ulcerative colitis or proctitis are only taken short-term. Ask your doctor when you can stop taking treatment.

    Research studies looking at patients who received daily oral doses of 4 to 6 grams of mesalamine showed that 80% of patients achieved complete or significant clinical improvement within 4 weeks.

    Mesalamine is an antiinflammatory, not an immunosuppressant. It may be one of the first treatments used for ulcerative colitis (UC) to lessen symptoms like diarrhea, rectal bleeding, or stomach pain. Immunosuppression is not a listed side effect for mesalamine. Other medicines used for UC, like prednisone, can suppress the immune system.

    The best time to take or use mesalamine will depend on the specific product you are using and why you are using it (ulcerative colitis induction or maintenance, ulcerative proctitis). Some products may need to be taken with food while others are taken on an empty stomach. Check with your doctor.

    Some forms of mesalamine are used long-term as a maintenance therapy in ulcerative colitis to help prevent symptoms from flaring up. Not all forms or brands of mesalamine are used long-term, so check with your doctor about your specific medicine. Call your doctor if your ulcerative colitis symptoms get worse after starting treatment.

    Brand name products of mesalamine may be more expensive than generic options. Some, but not all mesalamine products are available as generics. Your insurance should help pay for generics, or if you are paying out-of-pocket, ask your healthcare provider if there is a more affordable option.

    Mesalamine is available as delayed-release tablets or capsules, extended-release capsules, and rectal preparations like suppositories or enemas. The maximum dose will depend upon the specific product you are using and your diagnosis. Only use the dose prescribed by your doctor.

    Mesalamine is used in some patients with ulcerative colitis as a maintenance (long-term) treatment to help you stay in remission (without active symptoms). Other treatments for ulcerative colitis or proctitis are only taken short-term. Ask your doctor when you can stop taking treatment.

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