Mesalamine 400mg DR Capsules

Mesalamine is thought to exert its anti-inflammatory effects locally in the colon. It is believed to modulate inflammatory mediators, including inhibition of prostaglandin and leukotriene synthesis, and scavenging of free radicals. It may also inhibit the activity of nuclear factor-kappa B (NF-κB), a transcription factor involved in inflammatory responses.

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 immediate 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 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 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
+ 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. Many people may not experience any side effects or only minor ones. However, 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
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 allergic reaction you experienced, including any symptoms that occurred.
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, to ensure safe treatment, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Never start, stop, or change the dosage of any medication without first consulting your doctor to avoid potential interactions or complications.

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 every day, 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. If you observe this discoloration, monitor your urine flow. However, only contact your doctor if your urine appears reddish-brown before it comes into contact with any bleach-treated surfaces or water.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to direct sunlight, 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 condition that can cause severe brain and liver damage.

If you notice that parts of the medication are visible in your stool, and this occurs frequently, discuss this with your doctor.

The capsule coating of this medication contains iron. If you have high blood iron levels or take iron supplements or vitamins, inform your doctor to discuss potential interactions.

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

• Azathioprine
• 6-mercaptopurine
• Thioguanine
• NSAIDs (non-steroidal anti-inflammatory drugs)

• Lactulose (or other drugs that lower colonic pH)
• Antacids

• Worsening of ulcerative colitis symptoms (e.g., increased abdominal pain, bloody diarrhea, frequency of bowel movements)
• Fever
• Rash
• Chest pain
• Shortness of breath
• Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet)
• Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
• Unusual bruising or bleeding
• Severe headache

Generally considered low risk. Limited human data suggest no increased risk of major birth defects or miscarriage. Use only if clearly needed and the potential benefit justifies the potential risk to the fetus.

Mesalamine and its metabolite are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, but monitor infant for diarrhea.

Delzicol (mesalamine 400mg DR capsules) is not approved for pediatric use. Other mesalamine formulations (e.g., Lialda, Apriso, Pentasa) have specific pediatric indications for ulcerative colitis in certain age groups.

Use with caution, particularly regarding renal function, as elderly patients are more likely to have decreased renal function. Start at the lower end of the dosing range and monitor renal function closely.

• Mesalamine is a cornerstone therapy for induction and maintenance of remission in mild to moderate ulcerative colitis.
• Different mesalamine formulations (e.g., Delzicol, Lialda, Apriso, Pentasa, Asacol HD) have distinct release mechanisms and target different segments of the colon. It is crucial to use the correct formulation for the patient's disease location and severity.
• Patients should be instructed to swallow Delzicol capsules whole and not to chew, crush, or break them, as this can alter the delayed-release properties.
• Advise patients to report any new or worsening symptoms, especially severe abdominal pain, fever, rash, or chest pain, as these could indicate serious adverse reactions such such as acute intolerance syndrome, myocarditis, or pericarditis.
• Regular monitoring of renal and liver function is important, especially in patients with pre-existing impairment or those on concomitant nephrotoxic/hepatotoxic medications.

• Other 5-aminosalicylic acid (5-ASA) formulations (e.g., sulfasalazine, olsalazine, balsalazide)
• Corticosteroids (e.g., prednisone, budesonide) for induction of remission
• Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• Janus kinase (JAK) inhibitors (e.g., tofacitinib, upadacitinib)

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 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 for more information. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for proper treatment and care.