Mesalamine 500mg ER Capsules

Mesalamine (5-aminosalicylic acid, 5-ASA) is thought to exert its anti-inflammatory effect locally in the intestinal mucosa. Its exact mechanism is unknown but is believed to involve inhibition of prostaglandin synthesis (via cyclooxygenase inhibition) and leukotriene synthesis (via lipoxygenase inhibition), scavenging of free radicals, and inhibition of inflammatory cell migration and cytokine production.

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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
+ Back pain, belly pain, or blood in the urine (may indicate a kidney stone)
Chest pain or pressure, rapid heartbeat, 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
+ Rash
+ Red or pink eyes
+ General feeling of being unwell
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
+ 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 can affect body organs and be life-threatening
+ 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. However, many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Constipation
Diarrhea
Stomach pain
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, contact 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 your stomach valve or other types of stomach blockages
+ Blockages in your urinary tract (consult with your healthcare provider if you have this condition)

Additionally, provide your doctor and pharmacist with a comprehensive list of:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Any existing health problems

This information is crucial to ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

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.

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, please 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 safeguard your skin and eyes 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 developing Reye's syndrome, a rare but serious condition that can cause severe brain and liver damage.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.

• Azathioprine, Mercaptopurine, Thioguanine (increased risk of myelosuppression)
• NSAIDs (increased risk of nephrotoxicity with concomitant use of mesalamine)

• Nephrotoxic agents (e.g., aminoglycosides, cyclosporine, tacrolimus - increased risk of renal adverse reactions)
• Lactulose (may interfere with mesalamine release from pH-dependent formulations, but less relevant for Pentasa ER capsules)
• Furosemide (potential for increased risk of nephrotoxicity)

• Worsening abdominal pain or cramping
• Bloody diarrhea
• Fever
• Rash
• New or worsening nausea/vomiting
• Unexplained fatigue or weakness
• Dark urine or yellowing of skin/eyes (jaundice)
• Decreased urine output or swelling (signs of renal impairment)
• Chest pain or shortness of breath (myocarditis/pericarditis)
• New or worsening headache

Generally considered safe for use during pregnancy when clinically indicated for inflammatory bowel disease. Studies have not shown an increased risk of major birth defects. However, use should be carefully weighed against the risks of uncontrolled IBD.

Mesalamine and its metabolite are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding. Monitor breastfed infants for signs of diarrhea.

Safety and effectiveness of Pentasa capsules have not been established in pediatric patients. Other mesalamine formulations (e.g., granules, suppositories) are approved for pediatric use in ulcerative colitis. Use in pediatric Crohn's disease is off-label and based on clinical experience with other mesalamine products.

Use with caution in elderly patients, particularly those with pre-existing renal impairment, due to the increased risk of adverse renal reactions. Start at the lower end of the dosing range and monitor renal function closely.

• Pentasa capsules contain microgranules that are designed to release mesalamine throughout the small bowel and colon, making it suitable for Crohn's disease affecting various parts of the intestine.
• Patients should be instructed to swallow the capsules whole and not to chew, crush, or break them, as this can alter the extended-release properties.
• Mesalamine-induced acute intolerance syndrome (symptoms mimicking IBD flare, e.g., cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) is a rare but important adverse effect that requires immediate discontinuation.
• Regular monitoring of renal function is crucial due to the potential for mesalamine-induced nephrotoxicity, especially in patients with pre-existing renal issues or those on concomitant nephrotoxic medications.
• Patients should be advised to stay well-hydrated to minimize the risk of kidney stone formation and to support renal function.

• Corticosteroids (e.g., prednisone, budesonide) for induction of remission
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., anti-TNF agents like infliximab, adalimumab; anti-integrin agents like vedolizumab; IL-12/23 inhibitors like ustekinumab)
• Small molecule inhibitors (e.g., JAK inhibitors like tofacitinib)
• Antibiotics (e.g., metronidazole, ciprofloxacin) for perianal disease or bacterial overgrowth

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.