Apriso

DRUG DESCRIPTION

Each APRISO (mesalamine extended-release capsules) capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an anti-inflammatory drug. The structural formula of mesalamine is:

APRISO™ (mesalamine) Structural Formula Illustration

Molecular Weight: 153.14

Molecular Formula: C7H7NO3

Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above.

The inactive ingredients of APRISO (mesalamine extended-release capsules) capsules are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, simethicone emulsion ethylacrylate/methylmethacrylate copolymer nonoxynol 100 dispersion, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, aspartame, anhydrous citric acid, povidone, vanilla flavor, and edible black ink.

What are the possible side effects of mesalamine oral (Apriso, Asacol, Asacol HD, Lialda, Pentasa)?

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

Stop using mesalamine and call your doctor at once if you have any of these serious side effects:

  • severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other...

Read All Potential Side Effects and See Pictures of Apriso »

What are the precautions when taking mesalamine extended-release capsules (Apriso)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, pancreas problems (pancreatitis), swelling of the sac around the heart (pericarditis).

This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding....

Read All Potential Precautions of Apriso »


Apriso Consumer (continued)

SIDE EFFECTS: Diarrhea, headache, nausea, runny/stuffy nose, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, severe/prolonged headache.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, vomit that contains blood or looks like coffee grounds, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the eyes/skin, unusual bleeding/bruising, signs of infection (such as fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, pancreas problems (pancreatitis), swelling of the sac around the heart (pericarditis).

This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information.

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially the effects on the kidneys and decreased blood cell counts.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.


Apriso Patient Information Including Side Effects

Brand Names: Apriso, Asacol, Asacol HD, Lialda, Pentasa

Generic Name: mesalamine (oral) (Pronunciation: me SAL a meen)

  • What is mesalamine oral (Apriso)?
  • What are the possible side effects of mesalamine oral (Apriso)?
  • What is the most important information I should know about mesalamine oral (Apriso)?
  • What should I discuss with my healthcare provider before taking mesalamine oral (Apriso)?
  • How should I take mesalamine oral (Apriso)?
  • What happens if I miss a dose (Apriso)?
  • What happens if I overdose (Apriso)?
  • What should I avoid while taking mesalamine oral (Apriso)?
  • What other drugs will affect mesalamine oral (Apriso)?
  • Where can I get more information?

What is mesalamine oral (Apriso)?

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

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mesalamine oral (Apriso)?

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

Stop using mesalamine and call your doctor at once if you have any of these serious side effects:

  • severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

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.

What is the most important information I should know about mesalamine oral (Apriso)?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine).

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.

Call your doctor if you find undissolved tablets in your stool.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Related Drug Centers
  • Lialda
  • Asacol
  • Asacol HD
  • Apriso
  • Pentasa


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