Mesalamine 1.2gm Tablets

Mesalamine is an aminosalicylate that is thought to act locally in the colon to reduce inflammation in ulcerative colitis. Its exact mechanism is not fully understood but is believed to involve inhibition of cyclooxygenase and lipoxygenase pathways, thereby decreasing the production of prostaglandins and leukotrienes, which are inflammatory mediators. It may also scavenge free radicals and inhibit cytokine production.

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction: rash, 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, or swelling of the mouth, face, lips, tongue, or throat.
Kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant 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 resembling ulcerative colitis: new or worsening stomach pain or cramps, bloody stools, fever, headache, itching, rash, red or pink eyes, or general feeling of illness.
Liver problems (rare, but potentially life-threatening): dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellow skin and eyes.
Heart problems (rare, but potentially life-threatening): shortness of breath, significant weight gain, or swelling in the arms or legs.
Severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious reactions): 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; or swollen glands.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, others may have more bothersome symptoms. If you experience any of the following side effects, contact your doctor or seek medical attention:

Gastrointestinal symptoms: constipation, diarrhea, stomach pain, nausea, vomiting, or heartburn.
Gas or burping.
Nose or throat irritation.
Dizziness or headache.
Back pain.
Cough.

This list is not exhaustive. 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
Other health problems you may have

This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm 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, please 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 minimize your risk of sunburn.

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

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 to you and your baby.

• Nephrotoxic agents (e.g., NSAIDs, tacrolimus, cyclosporine): Increased risk of renal adverse reactions.
• Azathioprine, 6-mercaptopurine (6-MP): Increased risk of myelosuppression due to inhibition of thiopurine methyltransferase (TPMT) by mesalamine.

• Lactulose: May interfere with mesalamine release from pH-dependent formulations.
• Antacids: May interfere with mesalamine release from pH-dependent formulations.

• Worsening or new abdominal pain
• Bloody diarrhea
• Fever
• Rash
• Chest pain or shortness of breath (myocarditis/pericarditis)
• Unexplained bleeding or bruising
• Sore throat or fever (blood dyscrasias)
• Yellowing of skin or eyes, dark urine (liver injury)
• Decreased urine output, swelling (renal impairment)

Mesalamine is generally considered low risk during pregnancy. While animal studies have shown no evidence of harm, human data are limited but reassuring. Use only if clearly needed and potential benefits outweigh risks. Consult with a healthcare provider.

Mesalamine and its metabolite are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding (L2). Monitor breastfed infants for diarrhea.

Safety and effectiveness of mesalamine 1.2g tablets have not been established in pediatric patients. Other mesalamine formulations are approved for pediatric use in 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 consider overall health and comorbidities.

• Mesalamine is a cornerstone therapy for mild to moderate ulcerative colitis, acting locally in the colon.
• Different mesalamine formulations (e.g., Lialda, Apriso, Asacol HD, Pentasa) have distinct release mechanisms and target different parts of the GI tract. Ensure the correct formulation is prescribed for the patient's disease location.
• Patients should be advised to swallow tablets whole and not to chew, crush, or break them, as this can alter the drug's release properties.
• Monitor renal function, liver function, and CBC periodically, especially at baseline and during long-term therapy.
• Be aware of the rare but serious adverse events like acute intolerance syndrome (mimicking UC flare), myocarditis/pericarditis, and hypersensitivity reactions.
• Concomitant use with NSAIDs or other nephrotoxic drugs increases the risk of renal impairment.

• Sulfasalazine (another aminosalicylate)
• Corticosteroids (e.g., prednisone, budesonide) for induction of remission
• Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate) for maintenance
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab) for moderate to severe disease
• JAK inhibitors (e.g., tofacitinib) for moderate to severe disease

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.