Apriso ER

Apriso ER is an oral medication used to maintain remission in people with ulcerative colitis, helping prevent symptoms from returning. It contains mesalamine, an anti-inflammatory drug that reduces inflammation in the colon and rectum. Available in extended-release capsules, Apriso ER is typically taken once a day. It is available in one strength: 0.375 grams per capsule. The usual dosage is four capsules in the morning. While it is generally well tolerated, Apriso ER can cause side effects like headaches, diarrhea, and stomach pain. For best results, patients should follow their doctor's guidance on usage and monitor for any adverse reactions.

Apriso ER is a medication primarily prescribed for the long-term management of ulcerative colitis. It contains mesalamine, which works by reducing inflammation in the colon and rectum, helping to keep ulcerative colitis in remission and preventing flare-ups. The medication is available in extended-release capsules, meaning it gradually releases the active ingredient over time, providing consistent relief throughout the day. Apriso ER comes in one strength of 0.375 grams per capsule, with the usual dose being four capsules (1.5 grams) taken once a day in the morning.

For most patients, Apriso ER is well tolerated, but like any medication, it can cause side effects. Common side effects include headache, diarrhea, abdominal pain, and nausea. More serious side effects, though rare, may include kidney or liver issues, severe skin reactions, or allergic reactions. Because of these risks, regular monitoring and communication with your doctor are important, especially if you have a history of kidney or liver problems.

Patients should also be mindful of potential drug interactions, especially with antacids, NSAIDs, and other medications. Apriso ER can be taken with or without food, but it is important to maintain consistency in how it is taken. Always follow your doctor’s specific instructions for the best results.

Apriso ER is used to maintain remission in people with ulcerative colitis.

It helps prevent the symptoms of ulcerative colitis from returning by reducing inflammation in the colon and rectum. By keeping inflammation under control, Apriso ER helps prevent flare-ups and promotes ongoing remission of the condition.

What Are the Forms & Strengths of Apriso ER?

• Apriso ER is available in oral capsules that have both extended-release and delayed-release coatings.
  • Extended Release: The capsules release the medication slowly over time.
  • Delayed Release: The capsules pass through the stomach without dissolving, then release the medication once they reach the intestine.
• Strength: Apriso ER capsules are available in one strength: 0.375 grams (g) of mesalamine per capsule.
• Approved Dosage:
  • The usual dose to maintain remission of ulcerative colitis is four capsules (1.5 g) taken once a day in the morning.
  • Apriso ER can be taken with or without food.

What Is the Typical Dosage of Apriso ER?

The appropriate dosage of Apriso ER varies for each patient. It is crucial to follow the specific instructions provided by your doctor or those detailed on the medication's packaging label. The details shared here reflect only standard dosage guidelines; if your doctor has prescribed a different dose, always adhere to their instructions.

The dosage of Apriso ER you need will depend on its strength. The number of doses you take each day, the interval between each dose, and how long you continue taking the medication are all tailored to your specific health condition. Always communicate with your healthcare provider regarding your dosage plan, especially if there are any changes in your condition or if you have concerns about your medication regimen.

Dosage for Ulcerative Colitis

• Typical Dosage: The usual dose of Apriso ER is four capsules (1.5 grams total) taken once a day.
• When to Take: It is recommended to take the capsules in the morning.
• With or Without Food: Apriso ER can be taken with or without food.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they'll customize your dosage accordingly.]

Your doctor will provide detailed instructions on how to take Apriso ER, including the correct dosage and frequency. It's essential to adhere strictly to their guidance. They'll explain how much of the medication you need to take and how often you should take it to effectively manage your condition.

• Taking Apriso ER:
  • You should take Apriso ER once daily, preferably in the morning.
  • It's important to maintain consistency in how you take the medication—either with or without food.
  • Choose one method and stick to it every day to help maintain stable levels of the medication in your body.
  • Additionally, it's a good idea to drink plenty of water while you're on Apriso ER.
  • This can help to prevent kidney stones, which are a potential side effect of the medication.
• Combining Apriso ER with Other Medications:
  • Before you start taking any new medications alongside Apriso ER, make sure to discuss it with your doctor.
  • In many cases, Apriso ER alone is enough to keep your ulcerative colitis symptoms in remission. However, your doctor will work with you to determine the most effective treatment plan based on your specific needs.
  • If your symptoms of ulcerative colitis flare up again, your doctor may advise you to stop taking Apriso ER. In such cases, they might prescribe different medications to help bring your condition back under control. Always follow your doctor's instructions closely when it comes to managing your medication.
• Can Apriso ER be chewed, crushed, or split? No, Apriso ER capsules must be swallowed whole. Do not chew, crush, or split the capsules. If you find it difficult to swallow them, you should ask your doctor or pharmacist for advice on how to take them properly.
• Should I take Apriso ER with food? Apriso ER can be taken with or without food. The way you take it does not affect how much of the drug your body absorbs. However, it’s important to be consistent in how you take it each day. For instance, if you choose to take Apriso ER with your meals, make sure to always take it at mealtime. This consistency helps maintain steady levels of the medication in your bloodstream.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They'll adjust it as needed over time.]

Apriso ER contains mesalamine, also known as 5-aminosalicylic acid or 5-ASA. This medication is part of a group called aminosalicylates, which are drugs that all work in a similar manner. Aminosalicylates help reduce inflammation in the lining of your colon and rectum, which can lead to the healing of ulcers. These medications are effective in decreasing the number of flare-ups of symptoms, which helps symptoms improve over time. Although the exact mechanism of how Apriso ER and other aminosalicylates work is not fully understood, they are known to help keep inflammation in your bowel under control.

Once your ulcerative colitis is in remission, meaning the symptoms are under control or have disappeared, taking Apriso ER daily helps keep the inflammation from getting worse. This consistent use helps prevent your symptoms from returning. While Apriso ER begins working to reduce inflammation shortly after you start taking it, it may take several weeks for you to see an improvement in your symptoms.

What Are the Side Effects of Apriso ER?

Taking Apriso ER can result in various side effects, ranging from mild to more serious ones. Below is a list of some common side effects you may experience during the treatment with Apriso ER. Remember, this list is not comprehensive, and if you experience side effects that are persistent or bothersome, it's crucial to discuss them with your doctor or pharmacist. They can provide guidance on how to effectively manage these issues. Maintaining open communication with your healthcare provider is essential. It helps ensure that you can manage any side effects properly and continue caring for your overall health while undergoing treatment with this medication.

Common Side Effects of Apriso ER

When taking Apriso ER, you might notice some side effects. These are usually not serious and tend to go away after a few days or weeks. If these side effects don’t go away or start to bother you more, or if they become intense, it’s important to consult your doctor or pharmacist. Here’s a simple explanation of some common side effects you may experience:

• Headache: You may feel pain or a persistent ache in your head. This is a common reaction and can often be managed with over-the-counter pain relief if necessary.
• Diarrhea: You might experience loose, watery stools. It’s important to stay hydrated if this occurs.
• Upper Abdominal Pain: This can feel like a sharp or dull discomfort in the upper part of your belly, just below your ribs. This area may also feel tender.
• Nausea: This is a feeling of unease, as if you might vomit. It can occur with or without actual vomiting.
• Cold or Flu-like Symptoms: These could include symptoms such as a runny or stuffy nose, sore throat, cough, and general body aches.

Serious Side Effects of Apriso ER

While Apriso ER is generally safe, it can sometimes lead to serious side effects. These are rare, but it’s important to be aware of them. If you experience any of these, it’s crucial to contact your doctor right away. If the side effects seem life-threatening or you believe you're having a medical emergency, dial 911 or contact your local emergency services immediately. Here are some serious side effects to watch for, along with explanations of what they mean:

• Kidney Problems: Apriso ER can affect kidney function. Symptoms include:
  • Passing less urine: This could be a sign your kidneys aren’t working properly.
  • Swelling in your legs, feet, or ankles: This occurs when the kidneys can't remove enough fluid from the body.
  • Shortness of breath: Caused by fluid buildup in your body affecting lung function.
  • Feeling unusually tired: When kidneys aren’t working properly, your body may feel drained.
  • Nausea: This can happen when the kidneys fail to filter waste from your blood.
  • Confusion: The buildup of toxins in the body from kidney issues can affect brain function.
• Liver Problems: Apriso ER can cause liver damage in some people, especially if you have pre-existing liver issues. Symptoms include:
  • Jaundice (yellow skin or eyes): This happens when the liver can’t process waste properly, causing a buildup of bile.
  • Pain in the upper right side of your abdomen: The liver is located in this area, and pain can signal problems with its function.
• Mesalamine-Induced Acute Intolerance Syndrome: This rare condition can mimic the symptoms of an ulcerative colitis flare-up. Symptoms include:
  • Abdominal cramps or pain: A common sign of an active flare of ulcerative colitis.
  • Diarrhea that contains blood: Indicates serious inflammation in your intestines.
  • Fever: A rise in body temperature is often linked to inflammation or infection.
  • Headache: Could be linked to the body’s response to inflammation.
  • Rash: A skin reaction that may signal an intolerance to the medication.
• Severe Skin Reactions: Apriso ER can sometimes lead to severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, both of which can be life-threatening. Symptoms include:
  • Blistering or peeling rash: A severe skin reaction that can cause skin to slough off.
  • Fever and body aches: Often accompany severe skin reactions.
  • Cough: Can indicate respiratory involvement with skin reactions.
• Severe Allergic Reactions: Some people may have severe allergic reactions to Apriso ER, which could include:
  • Swelling: Especially in the face, tongue, or throat, which can block airways.
  • Trouble breathing: A common sign of an allergic reaction that requires immediate medical attention.
  • Rash: Can range from mild to severe, and may indicate an allergy to the medication.

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Before you start taking Apriso ER, it's essential to have a thorough discussion with your doctor about your medical history. This medication might not be suitable for everyone, especially if you have specific health conditions or factors that could affect your treatment. Here’s what you need to consider:

• Current or Past Kidney Problems or Use of Other Drugs that Can Harm Your Kidneys: If you have existing kidney issues or have used medications that could affect your kidneys, you need to be cautious with Apriso ER. This medication has the potential to cause or worsen kidney problems. Your doctor will want to monitor your kidney function closely, both before you begin treatment and as it progresses. If there's any indication that your kidney function is declining, your doctor might decide it’s best for you to stop using Apriso ER. Also, it’s important to discuss all other medications you’re currently taking with your doctor.
• An Allergy to Salicylate Drugs: Before starting Apriso ER, it’s critical to inform your doctor if you have allergies to salicylate drugs. This group includes medicines like aspirin, mesalamine (the active ingredient in Apriso ER), balsalazide (Colazal), olsalazine (Dipentum), and sulfasalazine (Azulfidine). If you've had an allergic reaction to any of these medications, you should avoid taking Apriso ER.
• Heart problems: Apriso ER has been linked in rare instances to myocarditis, which is an inflammation of the heart muscle, and pericarditis, which is inflammation of the lining around the heart. These conditions are serious and require careful consideration, especially if you have a history of heart problems. Before starting Apriso ER, discuss any past heart issues with your doctor to ensure this medication is a safe choice for you. They will assess the risks and decide whether Apriso ER is suitable for your health needs.
• Liver problems: If you have liver issues, it's crucial to know that Apriso ER could potentially cause or exacerbate liver problems. To safely manage your treatment, your doctor may conduct periodic blood tests to monitor your liver function while you are taking Apriso ER. If they notice a worsening in your liver health, they might advise you to discontinue the medication.
• Phenylketonuria (PKU): PKU is a genetic disorder that prevents the body from processing phenylalanine, an amino acid that is a component of proteins. People with PKU need to limit their intake of phenylalanine to prevent health complications. It's important to note that Apriso ER capsules contain aspartame, which breaks down into phenylalanine in your body, specifically providing 0.56 mg per dose. If you have PKU, you must discuss with your doctor whether it's safe for you to use Apriso ER, considering it contributes additional phenylalanine to your diet.
• Birth Control: Apriso ER has not been extensively researched in pregnant individuals. If you're sexually active and there's a possibility of pregnancy, it's crucial to discuss effective birth control options with your doctor while you're on Apriso ER. This conversation will help ensure that you're using the most appropriate and safe form of contraception during your treatment.
• Pregnancy: The safety of Apriso ER during pregnancy hasn't been fully established. While some studies have looked at mesalamine, the active ingredient in Apriso ER, and found no significant harm to pregnant individuals or their fetuses, conclusive evidence is still lacking. Managing your ulcerative colitis effectively during pregnancy is crucial, as active disease may increase risks such as premature birth and low birth weight in newborns. The American Gastroenterological Association (AGA) recommends that women should ideally achieve remission for at least three months before attempting pregnancy. Mesalamine, like Apriso ER, is often continued during pregnancy to maintain remission based on current guidelines. The perceived benefits of using mesalamine to control ulcerative colitis during pregnancy generally outweigh the potential risks. However, if you are pregnant or planning to become pregnant, it is essential to discuss with your doctor whether taking Apriso ER is advisable, weighing all possible risks and benefits.
• Breastfeeding: The active ingredient in Apriso ER, mesalamine, does transfer into breast milk, though in small quantities. There have been instances where children breastfed by individuals taking mesalamine have experienced diarrhea. According to the current guidelines from the American Gastroenterological Association, it is generally safe to breastfeed while taking mesalamine, provided that the baby is monitored for any signs of diarrhea. Discuss with your doctor the safest approach to feeding your baby while you are on this medication. If you choose to breastfeed while taking Apriso ER, it's important to watch for and report any diarrhea in your child to your healthcare provider immediately. This will help your doctor provide the best advice for continuing breastfeeding while managing your treatment effectively.

When taking Apriso ER, it's vital to stay in close communication with your doctor. Regular check-ups are crucial for monitoring the effectiveness of the medication and determining whether it's safe for you to continue using it. During these visits, your doctor can assess your response to the treatment and make any necessary adjustments to your dosage or therapy plan.

• If you experience symptoms like lower back or side pain, changes in urine output, blood in your urine, increased thirst, nausea, or swelling of your face and limbs, contact your doctor immediately. These could be signs of serious kidney issues, including kidney stones.
• If you notice stomach pain, bloody diarrhea, fever, or a rash, these may be signs of mesalamine-induced acute intolerance syndrome. This condition requires immediate medical attention.
• Symptoms such as difficulty breathing, swallowing, a fast heartbeat, itching, or swelling of the face and throat could indicate a severe allergic reaction. Seek medical help right away.
• Be alert for symptoms like skin blistering, peeling, red skin lesions, or severe rashes, which might suggest serious skin conditions such as Stevens-Johnson syndrome or DRESS. These require urgent care.
• Indicators of liver issues include upper stomach pain, pale stools, dark urine, loss of appetite, nausea, or yellowing of the skin or eyes. These symptoms should prompt an immediate call to your doctor.
• Apriso ER may increase your skin's sensitivity to sunlight, leading to severe sunburn or skin reactions, especially if you have conditions like eczema. Use sunscreen and avoid unnecessary sun exposure.
• Avoid taking antacids such as Maalox or Tums while on Apriso ER, as they can alter how the medication is absorbed and released in your body.
• Inform all healthcare providers, including your dentist, that you are taking mesalamine, as it may affect medical test results.
• Discuss all medications you are taking with your doctor, including over-the-counter and herbal supplements, to avoid interactions.

It’s vital to keep these precautions in mind and maintain open communication with your healthcare provider to ensure safe and effective use of Apriso ER.

• If you forget to take your Apriso ER dose in the morning, take it as soon as you remember on the same day. If it's nearly time for your next scheduled dose, though, just skip the missed one.
• Continue with your regular dosing schedule and do not take two doses at once to compensate for the missed dose, as doing so could increase your risk of experiencing side effects.
• To ensure you don't forget a dose, consider setting a reminder on your phone. This can help keep your treatment consistent and effective.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

It’s important not to take more Apriso ER than your doctor has prescribed. Taking too much of this medication can lead to serious side effects. Possible symptoms of an overdose include:

• Confusion
• Fast breathing
• Dizziness
• Headache
• Seizure
• Vomiting
• Ringing in your ears
• Abdominal pain
• Deeper breaths than usual
• Nausea

In very severe cases, an overdose of Apriso ER could cause some of your organs, such as your liver or kidneys, to stop functioning properly. If you think you have taken too much Apriso ER, call your doctor right away. You can also reach out to America’s Poison Centers at 800-222-1222 or use its online resource for guidance. However, if your symptoms feel severe or life-threatening, call 911 (or your local emergency number) or go to the nearest emergency room immediately.

[Note: If you consumed more than the recommended dose, get medical help right away, or call the Poison Help line at 1-800-222-1222.]

• Apriso ER capsules should be stored at room temperature, which should not exceed 77°F (25°C), in a tightly sealed container.
• Avoid keeping this medication in places that could become damp or wet, such as bathrooms.
• If you no longer need to take Apriso ER and have leftover medication, it is crucial to dispose of it safely. Doing so helps prevent others, including children and pets, from accidentally taking the drug. It also helps protect the environment from potential harm.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Apriso ER can interact with other medications, and these interactions can have different outcomes. For example, they might reduce the effectiveness of a drug or increase the likelihood of side effects. The list below provides some common examples of drugs that can interact with Apriso ER, but it doesn’t include every possible interaction. Before starting Apriso ER, make sure you tell your doctor and pharmacist about all the medications you’re taking, including any prescriptions, over-the-counter drugs, vitamins, herbs, and supplements. This information will help them identify and prevent potential issues.

• Apriso ER and NSAIDs: NSAIDs (nonsteroidal anti-inflammatory drugs) are common medications used to relieve pain and reduce inflammation. However, both NSAIDs and Apriso ER can affect your kidneys. When taken together, NSAIDs and Apriso ER can increase the risk of kidney problems. Some examples of NSAIDs that can raise this risk when combined with Apriso ER include:
  • Naprosyn, Aleve, Anaprox DS (naproxen)
  • Ibu-Tab, Motrin, Advil (ibuprofen)
  • Zorvolex, Zipsor (diclofenac)
  • Celebrex (celecoxib)

If you're already taking an NSAID, make sure to talk with your doctor before starting Apriso ER. Your doctor may suggest a different pain-relieving medication to avoid potential complications.

• Apriso ER and Antacids: Antacids help reduce stomach acid, providing relief for heartburn or indigestion (abdominal discomfort). However, taking antacids along with Apriso ER can interfere with how well the medication works. Apriso ER capsules have an acid-resistant coating that helps them pass through your stomach and dissolve in your intestines, where it’s needed most. When you take antacids with Apriso ER, the acid levels in your stomach are reduced, which can cause Apriso ER to dissolve prematurely in your stomach instead of reaching your intestines. This can make the medication less effective. Examples of antacids that could affect how well Apriso ER works include:
  • calcium carbonate/magnesium hydroxide (Rolaids)
  • aluminum hydroxide/magnesium hydroxide/simethicone liquid (Maalox, Mylanta)
  • calcium carbonate (Tums)
  • sodium bicarbonate (found in some Alka-Seltzer products)

To avoid this interaction, speak with your doctor if you need to take antacids while using Apriso ER.

• Apriso ER and 6-mercaptopurine: 6-mercaptopurine (6-MP) is a drug sometimes used to treat ulcerative colitis. However, it can affect your blood cells, leading to lower blood cell counts. When taken with Apriso ER, which contains mesalamine, it can increase the level of 6-MP in your blood. This may raise the risk of problems with your blood cells. If you’re taking both Apriso ER and 6-MP, your doctor might suggest periodic blood tests to monitor your blood cell counts and make sure everything is okay. If you have any concerns or questions about taking 6-MP with Apriso ER, don’t hesitate to talk with your doctor.
• Apriso ER and Azathioprine: Azathioprine (Imuran, Azasan) is another medication sometimes used for treating ulcerative colitis. Like 6-MP, it can affect your blood cells, leading to lower blood cell counts. When combined with Apriso ER, which contains mesalamine, azathioprine levels in your blood may increase. This could also raise the risk of blood cell problems. If you’re using both Apriso ER and azathioprine, your doctor might recommend regular blood tests to keep track of your blood cell counts.

If you have any questions or concerns about taking azathioprine with Apriso ER, be sure to discuss them with your doctor.

What Are the Other Apriso ER Interactions?

Apart from medicines, there are several other things that can interact with Apriso ER. Here are they:

• Apriso ER and Alcohol: There’s no known interaction between Apriso ER and alcohol. However, some people find that drinking alcohol can cause their ulcerative colitis to flare up. Additionally, if you experience headaches or nausea from taking Apriso ER, consuming alcohol could make these side effects worse. If you drink alcohol, it’s a good idea to talk with your doctor about how much is safe for you to drink while on this medication. In some individuals, alcohol may lead to symptoms such as:
  • Diarrhea
  • Cramping
  • Bloating
• Apriso ER and Lab Tests: Apriso ER may interfere with certain lab tests, including those used to check your normetanephrine level. Normetanephrine is a substance your body makes when breaking down norepinephrine (also called noradrenaline). If you need any lab tests while taking Apriso ER, make sure to inform your doctor so they can take this potential interaction into account.
• Apriso ER and Herbs and Supplements: There aren’t any specific herbs or supplements known to interact with Apriso ER. However, as with any new product, you should always check with your doctor or pharmacist before using any herbs or supplements while taking Apriso ER to ensure they won’t affect how your medication works.

[Note: This isn't a complete list, and there could be other drugs that interact with Apriso ER. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

There are other medications available that can help keep ulcerative colitis in remission (prevent symptoms from returning). Depending on your specific situation, some alternatives may be a better fit for you than others. If you’re considering a different option or looking for an alternative to Apriso ER, it’s important to discuss it with your doctor. They can provide guidance on other medications that might work well for your condition. Some of the drugs mentioned may be prescribed off-label to treat ulcerative colitis.

[Note: "Off-label use" refers to when a medication approved for one condition is used to treat a different condition.]

Alternatives for Ulcerative Colitis

Examples of other medications that may help maintain ulcerative colitis remission include:

• Biologics, like:
  • Humira (adalimumab)
  • Inflectra (infliximab)
  • Remicade (infliximab)
  • Simponi (golimumab)
  • Renflexis (infliximab)
  • Entyvio (vedolizumab)
• Aminosalicylates taken rectally, like:
  • Rowasa (mesalamine)
  • sfRowasa (mesalamine)
  • Canasa (mesalamine)
• Other aminosalicylates taken by mouth, like:
  • Dipentum (olsalazine)
  • Colazal (balsalazide)
  • Azulfidine (sulfasalazine)
  • Delzicol (mesalamine)
  • Lialda (mesalamine)
• Immunomodulators, like:
  • Imuran (azathioprine)
  • 6-MP (6-mercaptopurine)
  • Azasan (azathioprine)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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