Mesalamine Rectal Susp 28x60ml

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 inhibition of prostaglandin and leukotriene synthesis (via inhibition of cyclooxygenase and lipoxygenase pathways), scavenging of free radicals and reactive oxygen metabolites, and modulation of immune cell function (e.g., inhibition of cytokine production, inhibition of neutrophil chemotaxis). The rectal formulation delivers the drug directly to the site of inflammation in the distal colon and rectum.

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 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, trouble 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.
Cardiovascular issues: chest pain or pressure, rapid heartbeat, or irregular heartbeat.
Infections or blood disorders: fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Gastrointestinal issues: rectal bleeding or rectal pain.
Ulcerative colitis-like symptoms: 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

Most people experience minimal or no side effects. However, if you notice any of the following symptoms, contact your doctor if they bother you or persist:

Gastrointestinal issues: constipation, diarrhea, stomach pain, nausea, or vomiting.
Heartburn, gas, or burping.
Nose or throat irritation.
Dizziness or headache.
Back pain.
Cough.
Rectal irritation.

This list is not exhaustive. If you have 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 allergic reaction you experienced, including any symptoms that occurred.
Certain 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 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. 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. If you have a sulfite allergy, consult your doctor, as some products may contain sulfites.

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, monitor your urine flow and contact your doctor only if the discoloration persists.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.

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

Not all products are suitable for use in children, so consult your doctor before giving this medication 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 this may increase the risk of Reye's syndrome, a condition that can cause severe brain and liver damage.

Be aware that this medication may stain certain surfaces, including fabric, flooring, painted surfaces, marble, granite, vinyl, and enamel.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Azathioprine
• Mercaptopurine

• NSAIDs (e.g., ibuprofen, naproxen)
• Lactulose

• Worsening abdominal pain
• Rectal bleeding
• Diarrhea
• Fever
• Rash
• Signs of renal dysfunction (e.g., decreased urine output, swelling)
• Signs of hepatic dysfunction (e.g., yellowing of skin/eyes, dark urine, unusual fatigue)
• Unexplained bleeding or bruising
• Sore throat or fever (signs of blood dyscrasias)

Mesalamine is generally considered to be low risk during pregnancy. Studies in animals have not shown harm to the fetus, and human data suggest a low risk of adverse outcomes. However, it should be used during pregnancy 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 the infant for signs of diarrhea. Use with caution.

Mesalamine rectal suspension is used in children for ulcerative colitis, particularly distal disease. Dosing is often weight-based and should follow specific pediatric guidelines. Safety and efficacy in children younger than 2 years have not been established.

No specific dose adjustments are typically required based on age alone. However, elderly patients are more likely to have decreased renal function, so monitor renal function closely. Use with caution in patients with pre-existing renal or hepatic impairment.

• For best results, administer the enema at bedtime and try to retain it for at least 8 hours (or overnight).
• Lie on your left side during administration and for a few minutes afterward to help retain the enema.
• The enema may stain clothing or bedding, so take precautions.
• Ensure proper technique for administration to maximize local drug delivery and retention.
• Patients should be advised to report any signs of worsening symptoms, fever, rash, or signs of renal/hepatic dysfunction immediately.

• Corticosteroids (e.g., hydrocortisone rectal foam/enema, prednisone oral)
• Other aminosalicylates (e.g., sulfasalazine, olsalazine, balsalazide)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• Janus kinase (JAK) inhibitors (e.g., tofacitinib)
• Surgery (colectomy) for refractory cases

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't 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 details about the overdose, including the medication taken, the amount, and the time it occurred.