Mesalamine 800mg DR Tablets

Mesalamine (5-aminosalicylic acid, 5-ASA) is an anti-inflammatory agent that acts locally in the colon. Its exact mechanism is not fully understood but is thought to involve modulation of inflammatory mediators (e.g., leukotrienes, prostaglandins, cytokines), inhibition of nuclear factor-kappa B (NF-κB), and scavenging of free radicals. The delayed-release formulation ensures delivery of the active drug to the site of inflammation in the colon.

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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
+ Feeling 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
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
+ Signs of severe skin reactions 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. 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)

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 other medications and health conditions.

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. Your doctor will also instruct you to have regular blood tests to monitor your condition. Be aware that this drug may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this medication.

To stay hydrated, drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your liquid 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 touches 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. Use sunscreen and wear protective clothing and eyewear to prevent sun damage.

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, so consult with your doctor before giving it to a child. Additionally, do not give this medication to children and 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 notice that parts of the medication are visible in your stool, and this occurs frequently, discuss it with your doctor. It is also essential to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.

• Azathioprine, Mercaptopurine, Thioguanine: Increased risk of myelosuppression due to inhibition of thiopurine methyltransferase (TPMT) by mesalamine. Monitor CBC closely.
• Nephrotoxic agents (e.g., NSAIDs, tacrolimus): Increased risk of renal adverse reactions. Monitor renal function.

• Non-steroidal anti-inflammatory drugs (NSAIDs): May increase the risk of renal impairment when co-administered with mesalamine. Monitor renal function.
• Lactulose: May interfere with the pH-dependent release of mesalamine from delayed-release formulations, potentially reducing efficacy.

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

Mesalamine is generally considered low risk during pregnancy. Studies in pregnant women have not shown an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, some studies suggest a potential association with preterm birth and low birth weight, though confounding factors are often present. Use only if clearly needed and the potential benefits 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 or other adverse effects. If diarrhea develops in the infant, consider discontinuing breastfeeding or the drug.

Safety and effectiveness of Mesalamine 800mg DR Tablets have not been established in pediatric patients. Other mesalamine formulations are approved for pediatric ulcerative colitis.

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 assessment of renal function is crucial.

• Mesalamine is a locally acting anti-inflammatory agent; systemic absorption is minimized to maximize drug concentration at the site of inflammation in the colon.
• Different mesalamine formulations (e.g., delayed-release, extended-release, pH-dependent release, rectal) are designed to deliver the drug to specific parts of the GI tract. Ensure the correct formulation is prescribed for the patient's disease location.
• Patients should be instructed to swallow the tablets whole and not to chew, crush, or break them, as this can alter the drug's release properties.
• Acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) can occur and may be difficult to distinguish from a flare of IBD. Discontinue mesalamine if suspected.
• Rare but serious adverse effects include renal impairment, hepatotoxicity, and blood dyscrasias. Regular monitoring of renal and liver function, and CBC, is important.
• Patients should be advised to stay well-hydrated to minimize the risk of kidney stone formation.

• Other mesalamine formulations (e.g., Pentasa, Lialda, Apriso, Canasa, Rowasa)
• Corticosteroids (e.g., prednisone, budesonide)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• JAK inhibitors (e.g., tofacitinib, upadacitinib)
• Surgical intervention (colectomy) for refractory cases.

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 additional patient information leaflets, 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 seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.