Mesalamine 0.375gm Capsules

Mesalamine (5-aminosalicylic acid) is thought to exert its anti-inflammatory effects locally in the colon. Its exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin synthesis (via cyclooxygenase inhibition) and leukotriene synthesis (via lipoxygenase inhibition), scavenging of free radicals and reactive oxygen metabolites, and inhibition of inflammatory cell migration and cytokine production. The Apriso formulation is designed to deliver mesalamine to 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 or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
+ Back pain, abdominal pain, or blood in the urine (which may indicate a kidney stone)
Chest pain or pressure, rapid or irregular heartbeat
Fever, chills, sore throat, unexplained bruising or bleeding, or 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 or 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
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of heart problems, which can be rare but potentially life-threatening:
+ Shortness of breath
+ Significant weight gain
+ Swelling in the arms or legs
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect skin and 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 experience no side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:

Constipation
Diarrhea
Stomach pain or upset stomach
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.
Certain 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 if you have this condition)

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and medications.

Remember, do not 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 fluid 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 notice that your urine is reddish-brown before it comes into contact with any surfaces or water, contact your doctor.

You may be more susceptible to sunburn while taking this medication. To protect yourself, avoid exposure to the sun, sunlamps, and tanning beds, and use sunscreen and wear protective clothing and eyewear when going outside.

If you are 65 years or older, use this medication with caution, as you may be more prone to 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 give this medication to children or teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, as it 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, as they will need to discuss the potential benefits and risks of this medication with you and determine the best course of action for you and your baby.

• Azathioprine
• Mercaptopurine (6-MP)

• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
• Nephrotoxic agents (e.g., tacrolimus, cyclosporine, aminoglycosides)
• Lactulose (and other drugs that lower stool pH)

• Worsening of ulcerative colitis symptoms (e.g., increased frequency of bowel movements, rectal bleeding, abdominal pain)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet, fatigue)
• Signs of hepatic impairment (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, abdominal pain)
• Signs of hypersensitivity reactions (e.g., rash, fever, difficulty breathing, chest pain, pericarditis, myocarditis)
• Signs of acute intolerance syndrome (e.g., abdominal pain, cramping, bloody diarrhea, fever, headache, rash)
• Signs of pancreatitis (e.g., severe abdominal pain radiating to the back, nausea, vomiting)
• Signs of blood dyscrasias (e.g., unusual bruising or bleeding, persistent sore throat, fever, fatigue)

Mesalamine is generally considered low risk during pregnancy. Available data from published studies, postmarketing reports, and pregnancy registries over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, some studies suggest a potential for increased risk of preterm birth and low birth weight, though confounding factors are often present. Use only if clearly needed.

Mesalamine and its active metabolite (N-acetyl-5-ASA) are excreted in human milk in small amounts. While generally considered compatible with breastfeeding, monitor breastfed infants for signs of diarrhea. If diarrhea develops, discontinue breastfeeding or the drug.

Apriso is approved for the maintenance of remission of ulcerative colitis in pediatric patients 10 years of age and older. Safety and effectiveness have not been established in pediatric patients younger than 10 years of age.

No specific dose adjustments are required based on age alone. However, elderly patients are more likely to have decreased renal function, so monitoring of renal function is particularly important in this population. Use with caution in elderly patients with known or suspected renal impairment.

• Apriso is a delayed-release, extended-release formulation of mesalamine designed for once-daily dosing and targeted delivery to the colon. It must be taken with food.
• Patients should swallow the capsules whole and not crush, chew, or break them, as this will compromise the extended-release properties.
• Mesalamine can cause renal impairment, including interstitial nephritis. Regular monitoring of renal function is crucial, especially in patients with pre-existing renal disease, elderly patients, or those on concomitant nephrotoxic drugs.
• An acute intolerance syndrome resembling a flare of inflammatory bowel disease has been reported with mesalamine. Symptoms include cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash. If this occurs, discontinue therapy immediately.
• Caution is advised when co-administering mesalamine with azathioprine or mercaptopurine due to an increased risk of myelosuppression. Monitor CBC closely.
• Mesalamine can interfere with laboratory tests for normetanephrine, potentially leading to falsely elevated results.

• Other oral mesalamine formulations (e.g., Lialda, Asacol HD, Pentasa, Delzicol)
• Rectal mesalamine formulations (e.g., Rowasa enema, Canasa suppositories)
• Corticosteroids (e.g., prednisone, budesonide)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• Janus kinase (JAK) inhibitors (e.g., tofacitinib, upadacitinib)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.