Apriso capsules are only available as a brand-name medication. They're not currently available in generic form.

Apriso capsules contain one active drug ingredient: mesalamine. This drug is available in generic form as tablets and capsules. Like Apriso, these generic forms are also extended-release and delayed-release (see the "What is Apriso?" section above).

The generic forms of mesalamine don't come in the same strength as Apriso. Also, they release the drug in a slightly different way as they pass through your digestive system. Because of this, they're not considered direct equivalents of Apriso.

Other brand-name versions of mesalamine are also available. These include Asacol HD, Lialda, Delzicol, and Pentasa.

Apriso can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Apriso. These lists do not include all possible side effects.

For more information on the possible side effects of Apriso, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they've approved. If you would like to report to the FDA a side effect you've had with Apriso, you can do so through MedWatch.

More common side effects

The more common side effects of Apriso can include:

  • headache
  • diarrhea
  • upper abdominal (belly) pain
  • nausea
  • cold or flu-like symptoms

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Apriso aren't common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Kidney problems, including kidney failure. Symptoms can include:
    • passing less urine than usual
    • swollen ankles, feet, or legs
    • shortness of breath
    • feeling unusually tired
    • nausea
    • confusion
  • Liver problems, including liver failure in people who already have liver problems. Symptoms can include:
    • jaundice (yellowing of your skin or the whites of your eyes)
    • pain in the right side of your upper abdomen
  • Mesalamine-induced acute intolerance syndrome. Symptoms can be similar to a flare-up of ulcerative colitis. They can include:
    • abdominal (belly) cramps or pain
    • diarrhea that contains blood
    • fever
    • headache
    • rash
  • Severe allergic reactions. Symptoms are discussed in more detail below.

Side effect details

You may wonder how often certain side effects occur with this drug or whether certain side effects pertain to it. Here's more detailed information on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Apriso. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Allergic reactions that affect the heart have also been reported with other medications containing mesalamine (the active drug in Apriso). These include myocarditis (inflammation of the heart muscle) or the pericarditis (inflammation of the lining of the heart). Symptoms can include:

  • abnormal heartbeat
  • chest pain
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Apriso. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Hair loss

Hair loss is possible while taking Apriso. In clinical studies, this side effect was reported in less than 3% of people who took Apriso for up to 24 months.

Talk with your doctor if you're worried about hair loss while taking Apriso.

Fatigue

Apriso could cause fatigue (lack of energy). In clinical studies, fatigue was reported in less than 3% of people who took Apriso for up to 24 months. Fatigue can also be a symptom of ulcerative colitis.

Talk with your doctor if you're experiencing fatigue. They might do tests to rule out other possible causes, such as anemia. Your doctor may also suggest ways to help improve your energy levels.

Mesalamine-induced acute intolerance syndrome

Mesalamine (the active ingredient in Apriso) can sometimes cause acute intolerance syndrome, where your body is intolerant to the medication. This has symptoms that are very similar to a flare-up of ulcerative colitis. Symptoms can include:

  • abdominal pain or cramping
  • bloody diarrhea
  • fever
  • headache
  • rash

In clinical studies, this reaction was reported in 3% of people taking mesalamine or sulfasalazine (a drug that's changed into mesalamine in your body).

Tell your doctor if you get new or worsening ulcerative colitis symptoms, such as those listed above, while you're taking Apriso. If your doctor thinks you have acute intolerance syndrome, you'll need to stop taking Apriso.

Weight gain (not a side effect)

Weight gain was not reported in clinical studies of Apriso. However, taking Apriso can keep your ulcerative colitis in remission (prevent symptoms from returning). You may find you gain weight as your ulcerative colitis symptoms improve and you can eat foods you couldn't before.

Talk with your doctor if you're concerned about gaining weight while managing your ulcerative colitis.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Apriso comes as extended-release capsules. An extended-release form of a drug slowly releases the active ingredient over a certain period of time.

Apriso capsules pass through your stomach without being digested and then slowly release the medication as they pass through your intestine. Apriso capsules are only available in one strength: 0.375 g.

Dosage for ulcerative colitis

Apriso is approved to maintain remission (prevent symptoms from returning) of ulcerative colitis. The usual dose for this is four Apriso capsules (a total dose of 1.5 g) taken once a day in the morning.

What if I miss a dose?

If you forget to take your dose of Apriso in the morning, take it as soon as you remember that day. However, if it's almost time for your next dose, just skip the dose you missed. Take your next dose at the usual time.

Never take two doses together to make up for a missed dose. This can increase your risk of getting side effects.

To help make sure you don't miss a dose, try setting a reminder in your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Apriso is meant to be used as a long-term treatment. It helps keep your ulcerative colitis under control to stop your symptoms from coming back. If you and your doctor determine that Apriso is safe and effective for you, you'll likely take it long term.

Other drugs are available that can keep ulcerative colitis in remission (prevent symptoms from returning). Some drugs may be a better fit for you than others.

If you're interested in finding an alternative to Apriso, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Alternatives for ulcerative colitis

Examples of other drugs that may be used to keep ulcerative colitis in remission include:

  • other aminosalicylates taken by mouth, such as:
    • balsalazide (Colazal)
    • olsalazine (Dipentum)
    • sulfasalazine (Azulfidine)
    • other forms of mesalamine (Asacol, Lialda, Delzicol)
  • aminosalicylates taken rectally, such as:
    • mesalamine (Rowasa, sfRowasa, Canasa)
  • immunomodulators, such as:
    • azathioprine (Imuran, Azasan)
    • 6-mercaptopurine (6-MP)
  • biologics, such as:
    • adalimumab (Humira, Imraldi)
    • infliximab (Inflectra, Remicade, Renflexis)
    • golimumab (Simponi)
    • vedolizumab (Entyvio)

You may wonder how Apriso compares to other medications that are prescribed for similar uses. Here we look at how Apriso and Lialda are alike and different.

About

Apriso and Lialda both contain the active drug mesalamine. They belong to a class of medications called aminosalicylates. A class of medications is a group of drugs that work in a similar way.

Uses

Apriso is approved to maintain remission of ulcerative colitis (prevent symptoms from returning). Lialda is also approved to maintain remission of ulcerative colitis.

In addition, Lialda is approved to induce remission of mild to moderate ulcerative colitis. Inducing remission means treating active symptoms until they get better.

Drug forms and administration

Apriso comes as extended-release capsules containing 0.375 g of mesalamine. An extended-release form of a drug means it releases the drug slowly over a certain period of time.

Apriso capsules are also delayed-release, which means they have a special coating that allows them to pass through the stomach before dissolving.

The approved dose to maintain remission is four Apriso capsules (1.5 g) taken once a day in the morning. Apriso can be taken either with or without food.

Lialda comes as tablets containing 1.2 g of mesalamine. Like Apriso, Lialda tablets are both extended-release and delayed-release.

The dose to induce remission is two to four Lialda tablets (2.4 g to 4.8 g) taken once a day. The dose to maintain remission is two tablets (2.4 g) taken once a day. Lialda should be taken with food.

Side effects and risks

Apriso and Lialda have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Apriso, with Lialda, or with both drugs (when taken individually).

  • Can occur with Apriso:
    • nausea
    • cold or flu-like symptoms
  • Can occur with Lialda:
    • flatulence (passing gas)
    • abnormal results in liver function tests, which could be a sign of liver problems
  • Can occur with both Apriso and Lialda:
    • headache
    • diarrhea
    • abdominal pain

Serious side effects

This list contains examples of serious side effects that can occur with both Apriso and Lialda (when taken individually).

Can occur with both Apriso and Lialda:

  • kidney problems
  • liver problems
  • mesalamine-induced acute intolerance syndrome, which means your body is intolerant to the medication
  • serious allergic reactions

Effectiveness

Apriso and Lialda have slightly different FDA-approved uses, but they're both used to maintain remission of ulcerative colitis.

One review has compared the effectiveness of different forms of mesalamine for maintaining ulcerative colitis remission. It found that different forms of oral mesalamine seem to be similarly effective and safe when equal doses are compared.

Your doctor can prescribe Apriso at a higher dose than is approved. That would be an off-label (non-approved) use of the drug. Talk with your doctor to learn more.

Costs

Apriso and Lialda are both brand-name drugs. There's currently no generic form of Apriso. Generic forms of Lialda are available.

Brand-name medications usually cost more than generics. According to estimates on GoodRx.com, Lialda may cost more than Apriso.

The actual price you'll pay for either drug will depend on:

  • your insurance plan
  • your location
  • the pharmacy you use

Apriso and sulfasalazine are prescribed for similar uses. Below are details of how these medications are alike and different.

About

Apriso is a brand-name medication that contains the active drug mesalamine. Sulfasalazine, on the other hand, is a generic drug. It's available as the brand-name drug Azulfidine.

Sulfasalazine is prodrug of mesalamine. A prodrug is a medication that's changed into an active drug once it's inside your body.

Sulfasalazine passes through your digestive system to your colon. Once there, the bacteria found naturally in your colon split the sulfasalazine into the active drug mesalamine and another drug called sulfapyridine.

The mesalamine part produces the anti-inflammatory effect in your colon. The sulfapyridine part gets absorbed into your blood and may reduce inflammation in other parts of your body.

Uses

Apriso and sulfasalazine are both used to treat ulcerative colitis, but they're approved for use in slightly different ways.

Apriso is approved to maintain remission (prevent symptoms from returning) of ulcerative colitis in adults.

Sulfasalazine is approved for use in adults and in children ages 6 years and older. It's used to maintain remission and to induce remission (treat active symptoms) of ulcerative colitis.

In addition, delayed-release forms of sulfasalazine are approved to treat certain types of rheumatoid arthritis in adults and children ages 6 years and older. (A delayed-release form of a drug has a special coating that allows it to pass through the stomach before it dissolves.)

Drug forms and administration

Apriso comes as extended-release capsules containing 0.375 g of mesalamine. An extended-release form of a drug means it releases the drug slowly over a certain period of time.

Apriso capsules are also delayed-release, which means they have a special coating that allows them to pass through the stomach before dissolving.

The approved dose to maintain remission of ulcerative colitis in adults is four Apriso capsules (1.5 g) taken once a day in the morning.

Sulfasalazine comes as immediate-release tablets and delayed-release tablets, both containing 500 mg of sulfasalazine. The approved dosage to maintain remission of ulcerative in adults is 2 g daily, usually as one tablet taken four times a day. (This is approximately equivalent to 800 mg of mesalamine per day).

Side effects and risks

Apriso and sulfasalazine have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Apriso, with sulfasalazine, or with both drugs (when taken individually).

  • Can occur with Apriso:
    • diarrhea
    • cold or flu-like symptoms
  • Can occur with sulfasalazine:
    • orange or yellow discoloration of your urine or skin
    • vomiting
    • loss of appetite
    • reduced sperm count in men (reversible when you stop taking the drug)
  • Can occur with both Apriso and sulfasalazine:
    • headache
    • nausea
    • abdominal (belly) pain

Serious side effects

These lists contain examples of serious side effects that can occur with Apriso, with sulfasalazine, or with both drugs (when taken individually).

  • Can occur with Apriso:
    • mesalamine-induced acute intolerance syndrome, which means your body is intolerant to the medication
  • Can occur with sulfasalazine:
    • serious blood disorders, such as reduced levels of blood cells
    • serious skin reactions
    • lung problems, such as lung inflammation or pneumonia
    • nerve problems
  • Can occur with both Apriso and sulfasalazine:
    • kidney problems
    • liver problems
    • serious allergic reactions

Effectiveness

Apriso and sulfasalazine have different FDA-approved uses, but they're both used to maintain remission of ulcerative colitis.

One review of 12 clinical studies found mesalamine (the active drug in Apriso) to be less effective than sulfasalazine at maintaining remission of ulcerative colitis. Overall, 48% of people taking mesalamine in these studies had their symptoms return, compared to 43% of people taking sulfasalazine.

However, the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA) guidelines both recommend using mesalamine to maintain remission of ulcerative colitis. This is because sulfasalazine can cause more serious side effects.

The AGA does note that people who are already taking sulfasalazine and are in remission can keep taking the medication. And sulfasalazine might be a good option for people with ulcerative colitis who also have arthritis.

Costs

Apriso is a brand-name drug. It's not currently available in generic form. Sulfalsalazine is a generic drug. It's also available as the brand name medications Azulfidine and Azulfidine EN-tabs. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Apriso may be significantly more expensive than sulfasalazine. The actual price you'll pay for either drug will depend on:

  • your insurance plan
  • your location
  • the pharmacy you use

The Food and Drug Administration (FDA) approves prescription drugs such as Apriso to treat certain conditions.

Apriso has been approved by the FDA to maintain remission (prevent symptoms from returning) of ulcerative colitis in adults.

Ulcerative colitis is a chronic (long-term) condition that's a type of inflammatory bowel disease (IBD). With ulcerative colitis, the linings of your colon (large intestine) and rectum become inflamed (swollen). The inflammation can cause small sores, called ulcers, to develop in these parts of your bowel.

Symptoms of ulcerative colitis can include:

  • abdominal (belly) pain
  • rectal bleeding
  • diarrhea that may contain blood or mucus
  • nausea
  • loss of appetite
  • weight loss
  • fatigue (lack of energy)
  • fever
  • skin problems
  • joint pain

Ulcerative colitis affects people in different ways, and it tends to change over time.

You may have periods where the inflammation and ulcers in your bowel get worse, and your symptoms flare up. When this happens, your doctor can induce remission by treating these flare-ups until your symptoms go away.

Once you're in remission, taking medication such as Apriso can help you maintain remission. This means keeping the inflammation in your bowel under control to help prevent further flare-ups of your symptoms.

Effectiveness

In two clinical studies, Apriso was found to be effective at maintaining remission of ulcerative colitis. In these studies, people whose ulcerative colitis was in remission took Apriso or a placebo (a treatment with no active drug) for 6 months.

In the first study, 68% of people who took Apriso were still in remission (with no active symptoms) after 6 months. In comparison, 51% of people who took a placebo were still in remission after 6 months.

In the second study, 71% of people who took Apriso were still in remission after 6 months. In comparison, 59% of people who took a placebo were still in remission after 6 months.

Apriso off-label use to treat ulcerative colitis

Apriso is FDA-approved to maintain remission of ulcerative colitis in adults. Other forms of mesalamine (the active drug in Apriso) are also approved to induce remission. That means they treat active symptoms of ulcerative colitis. In fact, mesalamine is the preferred treatment for active symptoms of ulcerative colitis, according to clinical guidelines.

Research has shown that off-label use of Apriso to treat active ulcerative colitis may be effective. However, the dose of Apriso that was used in these studies (3 g per day) is higher than the dose used to maintain remission (1.5 g per day). More studies are needed to determine the right way to use Apriso to induce remission of ulcerative colitis.

If you're interested in using Apriso off-label to treat active symptoms of ulcerative colitis, talk with your doctor.

There's no known interaction between Apriso and alcohol. However, some people find that drinking alcohol can cause their ulcerative colitis to flare up.

In some people, alcohol may also cause symptoms like:

  • diarrhea
  • cramping
  • bloating

If you get headaches or feel nauseated from taking Apriso, drinking alcohol could make these side effects worse.

If you drink alcohol, talk with your doctor about how much is safe for you to drink.

Apriso can interact with other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Apriso and other medications

Below is a list of medications that can interact with Apriso. This list does not contain all drugs that may interact with Apriso.

Before taking Apriso, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Apriso and antacids

Antacids are drugs that lower the acid levels in your stomach. You take them to relieve heartburn or indigestion (stomach pain, discomfort, or bloating). Taking antacids at the same time as Apriso can stop Apriso from working properly.

Apriso capsules have a special acid-resistant coating that allows them to pass through your stomach without dissolving. The coating dissolves in your intestine, where there's less acid. This releases the drug exactly where it's needed.

Taking Apriso with antacids (which lower the acid levels in your stomach) could allow Apriso to dissolve in your stomach. This means it won't reach the part of your intestine it's supposed to treat.

Examples of antacids that can make Apriso less effective include:

  • sodium bicarbonate (an ingredient in some Alka-Seltzer products)
  • aluminum hydroxide/magnesium hydroxide/simethicone liquid (Maalox, Mylanta)
  • calcium carbonate/magnesium hydroxide (Rolaids)
  • calcium carbonate (Tums)

Apriso and NSAIDs

NSAIDs (nonsteroidal anti-inflammatory drugs) are pain-relieving drugs that reduce inflammation (swelling). NSAIDs and Apriso can both cause kidney problems on their own. Taking an NSAID with Apriso may increase your risk of having kidney problems.

Examples of NSAIDs that may increase the risk of kidney problems if taken with Apriso include:

  • ibuprofen (Ibu-Tab, Motrin, Advil)
  • naproxen (Naprosyn, Aleve, Anaprox DS)
  • diclofenac (Zorvolex, Zipsor)
  • celecoxib (Celebrex)

If you take an NSAID medication, talk with your doctor before you start using Apriso. They may suggest using a different medication to relieve your pain.

Apriso and azathioprine

Azathioprine (Imuran, Azasan) is a medication that's sometimes used to treat ulcerative colitis. It can cause problems with your blood cells, such as lowered blood cell counts.

Drugs that contain mesalamine, such as Apriso, can increase levels of azathioprine in your blood. This may raise your risk of having problems with your blood cells. If you take Apriso with azathioprine, you may need blood tests to monitor your blood cells from time to time.

If you would like to take azathioprine with Apriso, talk with your doctor about the risks and benefits.

Apriso and 6-mercaptopurine

The drug 6-mercaptopurine (6-MP) is sometimes used to treat ulcerative colitis. It can cause problems with your blood cells, such as lowered blood cell counts.

Drugs that contain mesalamine, such as Apriso, can increase levels of 6-mercaptopurine in your blood. This may raise your risk of having problems with your blood cells. If you take Apriso with 6-mercaptopurine, you may need blood tests to monitor your blood cells from time to time.

If you would like to take 6-mercaptopurine with Apriso, talk with your doctor about the risks and benefits.

Apriso and herbs and supplements

There aren't any herbs or supplements that have been specifically reported to interact with Apriso. However, you should still check with your doctor or pharmacist before using any of these products while taking Apriso.

Apriso hasn't been studied in pregnant women. However, there have been limited clinical studies of mesalamine (the active drug in Apriso) in pregnant women and in animals.

The results of these studies do not suggest that mesalamine has harmful effects in pregnant women or fetuses. However, as the safety of Apriso use during pregnancy is not fully established, it should only be used if it's clearly needed.

Although Apriso hasn't been studied in pregnant women, it's important that your ulcerative colitis is under control during your pregnancy. If your ulcerative colitis is active during your pregnancy, studies suggest this may increase your risk of having a premature birth.

It could also cause your baby to have a low birth weight. Current guidance from the American Gastroenterological Association (AGA) suggests that women should avoid getting pregnant until their disease has been in remission for at least 3 months.

For this reason, the AGA recommends that mesalamine (the active drug in Apriso) can be used during pregnancy to help keep the disease in remission. Current evidence suggests that the benefits of taking the drug to help keep ulcerative colitis in remission outweigh the possible risks.

If you're pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of taking Apriso during pregnancy.

Apriso hasn't been studied in pregnant women. If you're sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you're using Apriso.

Mesalamine, the active drug in Apriso, passes into breast milk in small amounts. Diarrhea has been reported in some breastfed children whose mothers were taking mesalamine.

Current guidance from the American Gastroenterological Association recommends that women can breastfeed while taking mesalamine if the child is monitored for diarrhea.

Talk with your doctor about the best way to feed your child while you're taking Apriso. If you decide to breastfeed while taking Apriso, tell your doctor if your child gets diarrhea.

As with all medications, the cost of Apriso can vary. To find current prices for Apriso in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you'll pay will depend on:

  • your insurance plan
  • your location
  • the pharmacy you use

Your insurance plan may require you to get prior authorization before it'll approve coverage for Apriso. This means that your doctor will need to send a request to your insurance company asking it to cover the drug.

The insurance company will review the request and let you and your doctor know if your plan will cover Apriso.

If you're not sure if you'll need to get prior authorization for Apriso, contact your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Apriso, or if you need help understanding your insurance coverage, help is available.

Salix Pharmaceuticals, the manufacturer of Apriso, offers a savings card that may help lower the cost of Apriso. For more information and to find out if you're eligible for support, visit the program website.

You should take Apriso according to your doctor or healthcare provider's instructions.

When to take

Take your dose of Apriso once a day, in the morning.

To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Don't take antacid medications at the same time as Apriso.

Taking Apriso with food

You can take Apriso with or without food.

Can Apriso be crushed, split, or chewed?

No, Apriso capsules should be swallowed whole.

The capsules have a special coating that lets them pass through your stomach without being digested. The coating dissolves in your intestine, allowing the drug to be released where it's needed. If you crush, split, or chew the capsules, you will damage the coating and prevent Apriso from working properly.

ulcerative colitis

What happens in ulcerative colitis

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that affects your colon (large intestine) and rectum. With this condition, the linings of these parts of your bowel become inflamed (swollen). The inflammation causes small sores, called ulcers, to develop on the linings.

An inflamed and irritated bowel causes symptoms such as abdominal (belly) pain, rectal bleeding, and diarrhea that may contain blood or mucus. Ulcerative colitis can also cause other symptoms, such as:

  • nausea
  • loss of appetite
  • weight loss
  • fatigue (lack of energy)
  • anemia

Ulcerative colitis is a chronic (long-term) condition. You may have periods of time when your symptoms go away and times when they return.

When the inflammation in your bowel is active, your symptoms can flare up. At this point, you'll need treatment to help reduce the inflammation in your bowel. Once your condition is in remission (symptoms have gone away), you'll take treatment to help keep the condition in remission.

What Apriso does

Apriso contains the active drug mesalamine, also known as 5-aminosalicylic acid or 5-ASA. It belongs to a class of medications called aminosalicylates. A class of medications is a group of drugs that work in a similar way.

Aminosalicylates reduce inflammation in the linings of your colon and rectum, which may allow the ulcers to heal. They control flare-ups of the disease, which makes the symptoms go away. However, the way they work is not fully understood.

Once the condition is in remission, taking an aminosalicylate such as Apriso every day helps keep the inflammation in your bowel under control. This helps prevent your symptoms from flaring up again.

How long does it take to work?

Apriso will start working to control inflammation in your bowel soon after you take it. However, it might take a few weeks before you notice your symptoms get better.

Here are answers to some frequently asked questions about Apriso.

Do I need to take Apriso at a certain time of the day?

Yes, you should take your dose of Apriso in the morning. You can take it before, after, or with your breakfast.

Is Apriso a steroid?

No, Apriso is not a steroid.

It belongs to a class of drugs called aminosalicylates. (A class of drugs is a group of medications that work in a similar way.) Like steroids, aminosalicylates reduce inflammation (swelling) in your bowel. However, they work in a different way than steroids and usually have fewer side effects.

Will Apriso cure my ulcerative colitis?

No. It's not currently possible to cure ulcerative colitis.

However, you can treat the condition until you no longer have symptoms. This is called inducing remission.

It's also possible to keep the disease well-managed and stop your symptoms from flaring up again. This is called maintaining remission. Taking Apriso every day is effective for maintaining remission of ulcerative colitis in about 70% of people.

Is Apriso safe for use by older adults?

Yes, older adults can take Apriso. However, as with all drugs, your doctor may take extra precautions when prescribing it. Your kidneys, liver, and heart get less effective as you age, and this can make certain side effects more likely. In rare cases, mesalamine (the active drug in Apriso) can affect your blood cells, and this side effect may be more likely in people ages 65 and older.

Older adults are also more likely to have other conditions or be taking other drugs that could affect how Apriso works.

If you're age 65 years or older, your doctor may order extra tests before you start taking Apriso to make sure it's safe for you. They may also order extra tests throughout your treatment with Apriso to make sure it's not having unwanted effects.

Before taking Apriso, talk with your doctor about your health history. Apriso may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • An allergy to salicylate drugs. These include aspirin, mesalamine (Apriso), balsalazide (Colazal), olsalazine (Dipentum), and sulfasalazine (Azulfidine). Apriso is a salicylate, so do not take it if you've ever had an allergic reaction to a salicylate medication.
  • Kidney problems. Apriso can cause kidney problems and could worsen any kidney problems you already have. Your doctor will regularly check how well your kidneys are working before and during your treatment with Apriso. If any kidney problems get worse, you may need to stop taking Apriso.
  • Liver problems. Apriso can cause liver problems and could worsen any liver problems you already have. You may need blood tests to check your liver function from time to time while taking Apriso. If any liver problems get worse, you may need to stop taking Apriso.
  • Heart problems. In rare cases, mesalamine (the active drug in Apriso) can cause myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining of the heart). Talk with your doctor if you've ever had heart problems so they can determine if Apriso is safe for you.
  • Phenylketonuria (PKU). This is a disorder where your body can't process an amino acid called phenylalanine. (Amino acids are the building blocks that make up proteins.) If you have PKU, you need to minimize the amount of phenylalanine you consume to avoid it building up in your body. You also need to avoid consuming aspartame, because your body breaks this down into phenylalanine. Apriso capsules contain aspartame, equivalent to 0.56 mg of phenylalanine. If you have PKU, talk with your doctor about whether Apriso is safe for you to take.
  • Pregnancy. Apriso hasn't been studied in pregnant women. For more information, see the "Apriso and pregnancy" section above.
  • Breastfeeding. Mesalamine, the active drug in Apriso, passes into breast milk in small amounts. For more information, see the "Apriso and breastfeeding" section above.

Note: For more information about the potential negative effects of Apriso, see the "Apriso side effects" section above.

Using more than the recommended dosage of Apriso can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose of Apriso can include:

  • ringing in the ears or trouble hearing
  • confusion
  • drowsiness
  • seizures
  • fast breathing
  • trouble breathing
  • vomiting blood

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Apriso from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the medication will be effective during this time.

The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Apriso capsules should be stored at room temperature (no higher than 77°F or 25°C) in a tightly sealed container. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Apriso and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Apriso is approved to maintain remission of ulcerative colitis in adults ages 18 years and older.

Mechanism of action

Apriso contains the active drug mesalamine, also known as 5-aminosalicylic acid or 5-ASA.

The exact mechanism of mesalamine is not fully understood. It's thought to reduce production of inflammatory prostaglandins and leukotrienes in the mucosal linings of the colon and rectum.

Apriso extended-release capsules have an enteric coating that dissolves at pH 6 and above. They release mesalamine in the colon, where it produces a local effect.

Pharmacokinetics and metabolism

Approximately 32% of the dose is absorbed systemically following oral administration of Apriso. After multiple doses, steady state is reached in 6 days.

Mesalamine is metabolized in the liver and intestinal mucosa, mainly to N-acetyl-5-aminosalicylic acid. The major metabolite is excreted in the urine. About 2% of the dose is excreted by the kidneys as unchanged drug.

After multiple doses of Apriso, the mean half-life is 9 to 10 hours for mesalamine and 12 to 14 hours for N-acetyl-5-aminosalicylic acid.

Contraindications

Apriso is contraindicated in people with an allergy to:

  • aminosalicylates
  • salicylates, including aspirin
  • any of the excipients in Apriso capsules

Storage

Apriso capsules should be stored at room temperature, not exceeding 77°F (25°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.