Mesalamine 0.375gm ER Capsules

Mesalamine (5-aminosalicylic acid or 5-ASA) is thought to exert its anti-inflammatory effect locally in the colon. Its exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin and leukotriene synthesis (via inhibition of cyclooxygenase and lipoxygenase pathways), scavenging of free radicals, and inhibition of inflammatory cell migration into the inflamed bowel wall. The extended-release formulation of Apriso is designed to deliver mesalamine throughout the colon.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
+ Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone)
Chest pain or pressure
Rapid or irregular heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Symptoms that may resemble ulcerative colitis, such as:
+ New or worsening stomach pain or cramps
+ Bloody stools
+ Fever
+ Headache
+ Itching
+ Rash
+ Red or pink eyes
+ General feeling of illness
Signs of liver problems, which can be rare but potentially life-threatening:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart problems, which can be rare but potentially life-threatening:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that may affect internal organs
+ Symptoms may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor:

Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Heartburn
Gas
Burping
Nose or throat irritation
Dizziness or headache
Back pain
Cough

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Existing health conditions, including:
+ Kidney disease or liver disease
+ Stomach or bowel ulcers
+ Narrowing of the stomach valve or other types of stomach blockages
+ Blockages in the urinary tract (consult with your healthcare provider)
Other medications you are taking, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any health problems you have, as this is not an exhaustive list of potential interactions with this medication.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

To stay hydrated, drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your liquid intake.

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products may contain phenylalanine.

While taking this medication, you may notice that your urine turns reddish-brown when it comes into contact with surfaces or water that have been treated with bleach, such as in the toilet. However, if you observe that your urine is reddish-brown before it comes into contact with any surfaces or water that may have been treated with bleach, contact your doctor.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to shield yourself from the sun.

If you are 65 years or older, use this medication with caution, as you may be more prone to experiencing side effects.

Not all formulations of this medication are suitable for children. Before giving this medication to a child, consult with your doctor to determine the appropriate dosage and potential risks.

Do not administer this medication to children and teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, as this may increase the risk of Reye's syndrome, a condition that can cause severe brain and liver damage.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.

• Nephrotoxic agents (e.g., NSAIDs, azathioprine, mercaptopurine): Increased risk of renal adverse reactions. Avoid concomitant use or monitor renal function closely.
• Azathioprine/Mercaptopurine: Increased risk of myelosuppression due to inhibition of thiopurine methyltransferase (TPMT) by mesalamine. Monitor CBC closely.

• Proton Pump Inhibitors (PPIs): May affect the dissolution of mesalamine extended-release capsules, potentially leading to premature release. Monitor for decreased efficacy.
• Lactulose: May interfere with the release of mesalamine from the extended-release formulation. Monitor for decreased efficacy.

• Signs of renal impairment (e.g., decreased urine output, swelling, fatigue)
• Signs of liver injury (e.g., jaundice, dark urine, abdominal pain, nausea, vomiting)
• Signs of blood dyscrasias (e.g., fever, sore throat, unusual bleeding or bruising, fatigue)
• Signs of acute intolerance syndrome (e.g., cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash)
• Signs of hypersensitivity reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
• Signs of worsening ulcerative colitis symptoms (e.g., increased frequency of bowel movements, bloody stools, abdominal pain)

Mesalamine is generally considered to be low risk during pregnancy. Studies in pregnant women have not shown an increased risk of major birth defects or miscarriage. However, use during pregnancy should be carefully considered, and the benefits should outweigh the potential risks.

Mesalamine and its metabolite are excreted in breast milk in small amounts. While generally considered compatible with breastfeeding, monitor breastfed infants for signs of diarrhea.

Safety and effectiveness of Apriso in pediatric patients have not been established. Other mesalamine formulations may be used in pediatric populations for ulcerative colitis, but specific dosing for Apriso is not available.

Use with caution in elderly patients, as they are more likely to have decreased renal function. Monitor renal function closely. No specific dose adjustment is typically required based solely on age, but individual patient factors should be considered.

• Apriso is an extended-release formulation designed for once-daily dosing, which can improve patient adherence.
• Always instruct patients to swallow the capsules whole; chewing or crushing will alter the extended-release properties and may lead to premature release and reduced efficacy or increased side effects.
• Take with food to ensure proper dissolution and absorption.
• Emphasize the importance of regular monitoring of renal function, especially in patients with pre-existing renal impairment or those taking concomitant nephrotoxic medications.
• Educate patients about the signs of acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) and to report them immediately, as this requires discontinuation of the drug.
• Mesalamine can cause discoloration of urine or feces, which is generally harmless but can be alarming to patients.

• Other oral 5-aminosalicylates (5-ASAs): Lialda (mesalamine delayed-release tablets), Asacol HD (mesalamine delayed-release tablets), Pentasa (mesalamine extended-release capsules)
• Rectal 5-aminosalicylates (e.g., Rowasa, Canasa) for distal colitis
• Corticosteroids (e.g., prednisone, budesonide) for induction of remission
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• Janus Kinase (JAK) inhibitors (e.g., tofacitinib)

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, including the dosage, time of ingestion, and any other relevant details.