Mesalamine Rectal Susp 7x60ml

Mesalamine (5-aminosalicylic acid, 5-ASA) is thought to exert its anti-inflammatory effects locally in the colon. While the exact mechanism is not fully understood, it is believed to modulate local inflammatory mediators, including leukotrienes and prostaglandins, by inhibiting cyclooxygenase and lipoxygenase pathways. It may also scavenge free radicals and reactive oxygen metabolites, inhibit cytokine production, and modulate immune cell function in the intestinal mucosa.

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 or seek medical attention immediately:

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.
Signs of kidney problems: inability to pass urine, 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 abnormal heartbeat.
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Rectal bleeding or rectal pain.
Symptoms that may resemble ulcerative colitis: new or worsening stomach pain or cramps, bloody stools, fever, headache, itching, rash, red or pink eyes, or general feeling of illness.

Rare but Serious Side Effects

Liver problems: although rare, this medication can cause liver damage, which can be life-threatening. Seek medical help immediately if you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart problems: this medication can cause heart problems, which can be life-threatening. Seek medical help immediately if you experience shortness of breath, significant weight gain, or swelling in the arms or legs.
Severe skin reactions: this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may affect other organs. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Not everyone who takes this medication will experience side effects. However, if you do experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Constipation, diarrhea, stomach pain, nausea, vomiting, or heartburn.
Gas or burping.
Nose or throat irritation.
Dizziness or headache.
Back pain.
Cough.
Rectal irritation.

Reporting Side Effects

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, other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as kidney disease or liver disease.
The presence of a stomach or bowel ulcer.
Any narrowing of your stomach valve or other type of stomach blockage.
* If you have a blockage in your urinary tract, consult with your healthcare provider.

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. Do not initiate, stop, or modify 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 with 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 a 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, and use sunscreen and wear protective clothing and eyewear when outdoors.

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 children, so consult with 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 it 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 you and your baby.

• Nephrotoxic agents (e.g., NSAIDs, azathioprine, mercaptopurine): Increased risk of renal adverse reactions.
• Azathioprine, Mercaptopurine: Increased risk of myelosuppression due to inhibition of thiopurine methyltransferase (TPMT).

• Lactulose: May interfere with mesalamine release from oral formulations (less relevant for rectal suspension, but theoretical concern for colonic pH).
• Furosemide: Potential for increased risk of nephrotoxicity.

• Worsening abdominal pain or cramping
• Bloody diarrhea
• Fever
• Rash
• Chest pain or shortness of breath (potential pericarditis/myocarditis)
• Unexplained fatigue, bruising, or bleeding (blood dyscrasias)
• Dark urine, yellowing of skin/eyes (liver dysfunction)
• Decreased urine output, swelling (renal dysfunction)

Mesalamine is generally considered low risk during pregnancy (Category B). Studies in animals have not shown harm, and human data suggest no increased risk of major birth defects. However, use only if clearly needed and potential benefits outweigh risks.

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

Safety and efficacy of mesalamine rectal suspension have not been established in pediatric patients. Oral mesalamine formulations are approved for some pediatric indications.

Use with caution in elderly patients, especially those with pre-existing renal or hepatic impairment, due to increased susceptibility to adverse reactions. Start at the lower end of the dosing range and monitor renal function closely.

• Mesalamine rectal suspension is most effective for distal ulcerative colitis (proctitis, proctosigmoiditis) due to its local action.
• Instruct patients on proper administration technique to ensure maximum retention and efficacy.
• Advise patients to retain the enema for as long as possible, ideally overnight (at least 8 hours).
• Patients should be aware of potential for rare but serious adverse effects like renal impairment, hepatotoxicity, and blood dyscrasias, and report any concerning symptoms.
• Concomitant use with NSAIDs or other nephrotoxic drugs should be approached with caution and increased renal monitoring.
• Some patients may experience transient rectal irritation or discomfort upon administration.

• Oral mesalamine formulations (e.g., tablets, capsules)
• Corticosteroid enemas or foams (e.g., hydrocortisone, budesonide rectal foam)
• Oral corticosteroids (for more extensive or severe disease)
• Immunomodulators (e.g., azathioprine, mercaptopurine)
• Biologic agents (e.g., infliximab, adalimumab)
• Janus kinase (JAK) inhibitors (e.g., tofacitinib)

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