Mesalamine 4gm Kit (4 Kits)

Mesalamine (5-aminosalicylic acid) is thought to exert its anti-inflammatory effect locally in the colon. It is believed to modulate local inflammatory responses by inhibiting cyclooxygenase and lipoxygenase pathways, thereby decreasing the production of prostaglandins and leukotrienes. It may also act as a free radical scavenger and inhibit the activity of nuclear factor-kappa B (NF-κB), a transcription factor involved in inflammatory processes.

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 (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
Rectal bleeding or pain
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
Liver problems, which can be rare but potentially life-threatening, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart problems, which can be rare but potentially life-threatening, including:
+ 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 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 if they bother you or persist, contact your doctor:

Constipation
Diarrhea
Stomach pain or upset stomach
Vomiting
Heartburn
Gas
Burping
Nose or throat irritation
Dizziness or headache
Back pain
Cough
* Rectal irritation

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.
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
Any health problems you have, as this is not an exhaustive list of potential interactions with this medication.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

Important Information to Share with Your Healthcare Team

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure you receive proper care and avoid potential interactions.

Monitoring Your Health

Follow your doctor's instructions for regular blood tests to monitor your health while taking this medication. Discuss any concerns or questions you have with your doctor.

Lab Tests and Results

This medication may affect the results of certain lab tests. Be sure to inform all your healthcare providers and lab personnel that you are taking this medication to ensure accurate test results.

Staying Hydrated

Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

Sulfite Allergy

If you have a sulfite allergy, consult with your doctor before taking this medication, as some products may contain sulfites.

Urine Color Change

While taking this medication, your urine may turn reddish-brown when it comes into contact with surfaces or water that have been treated with bleach (e.g., toilet water). If you notice this color change, observe your urine flow. Only contact your doctor if your urine appears reddish-brown before it comes into contact with any surfaces or water that may have been treated with bleach.

Sun Protection

You may be more susceptible to sunburn while taking this medication. To protect yourself, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when spending time outdoors.

Special Considerations for Older Adults

If you are 65 or older, use this medication with caution, as you may be more prone to side effects.

Use in Children

Not all products are suitable for use in children. Consult with your doctor before giving this medication to a child. Additionally, 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 serious brain and liver problems.

Staining and Discoloration

This medication may stain fabric, flooring, painted surfaces, marble, granite, vinyl, and enamel.

Pregnancy and Breastfeeding

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 you and your baby.

• Azathioprine, Mercaptopurine (6-MP): 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 dysfunction when co-administered with mesalamine.
• Lactulose: May interfere with the release of mesalamine from some oral formulations (less relevant for rectal enema, but theoretical consideration).

• Worsening of ulcerative colitis symptoms (e.g., increased rectal bleeding, diarrhea, abdominal pain)
• Signs of hypersensitivity reaction (e.g., rash, fever, difficulty breathing, chest pain, pericarditis, myocarditis)
• Signs of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
• Signs of hepatic dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
• Signs of blood dyscrasias (e.g., unusual bruising/bleeding, persistent sore throat, fever, fatigue)
• Acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash)

Mesalamine is generally considered safe for use during pregnancy for the treatment of inflammatory bowel disease. Untreated or poorly controlled IBD can pose greater risks to pregnancy outcomes than mesalamine exposure. Category B indicates no evidence of risk in animal studies, but no adequate and well-controlled studies in pregnant women.

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

Safety and effectiveness have not been established in pediatric patients. Use in children is generally off-label and requires careful consideration of risks vs. benefits by a specialist.

Use with caution in elderly patients, particularly those with pre-existing renal, hepatic, or cardiac impairment, due to increased susceptibility to adverse reactions. Monitor renal function closely.

• Ensure proper administration technique for the enema: lie on the left side, insert the applicator tip, squeeze the bottle, and retain the enema for at least 8 hours, ideally overnight.
• Patients should be advised that the enema solution may stain clothing and bedding.
• Mesalamine rectal enema is specifically for distal ulcerative colitis (proctitis, proctosigmoiditis, left-sided colitis) and may not be effective for more extensive disease.
• Regular monitoring of renal function is crucial, especially in patients with pre-existing renal disease or those on concomitant nephrotoxic medications.
• Acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) can occur and may be difficult to distinguish from an exacerbation of ulcerative colitis. If suspected, discontinue therapy immediately.

• Oral 5-ASAs (e.g., mesalamine tablets, sulfasalazine)
• Corticosteroids (e.g., hydrocortisone rectal foam/enema, oral prednisone)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• Janus Kinase (JAK) inhibitors (e.g., tofacitinib)

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 check 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 medication taken, the amount, and the time it occurred.