Mesalamine 1000mg Suppositories

Mesalamine (5-aminosalicylic acid, 5-ASA) is thought to exert its anti-inflammatory effects locally in the colon. Its mechanism of action is not fully understood but is believed to involve inhibition of prostaglandin and leukotriene synthesis (via inhibition of cyclooxygenase and lipoxygenase pathways), scavenging of free radicals and reactive oxygen metabolites, and inhibition of inflammatory cell migration and cytokine production. The rectal formulation delivers the active drug directly to the site of inflammation in the rectum and distal 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
+ General feeling of illness
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
+ 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 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
* 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.
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)
Although this is not an exhaustive list, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that 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 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 a toilet. If you observe this discoloration, monitor your urine flow. However, only contact your doctor if your urine appears reddish-brown before it comes into contact with any bleached surfaces or water.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to shield yourself from the sun.

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 administering this drug to a child, consult with your doctor to determine the appropriate dosage and potential risks.

Do not give this medication to children or teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, as this may increase the risk of developing Reye's syndrome, a potentially life-threatening condition that affects the brain and liver.

Be aware that this medication may stain certain materials, 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 they will need to discuss the potential benefits and risks of this medication to you and your baby.

• Azathioprine
• Mercaptopurine

• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
• Nephrotoxic agents (e.g., tacrolimus, cyclosporine)
• Lactulose and other laxatives (may interfere with mesalamine release/absorption, though less relevant for suppositories)

• Worsening of ulcerative proctitis symptoms (e.g., increased rectal bleeding, urgency, tenesmus)
• Signs of hypersensitivity reactions (e.g., rash, fever, chest pain, shortness of breath)
• Symptoms of renal impairment (e.g., decreased urine output, swelling, fatigue)
• Symptoms of blood dyscrasias (e.g., unusual bruising, bleeding, persistent sore throat, fever)
• Symptoms of hepatotoxicity (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
• Symptoms of acute intolerance syndrome (e.g., cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash)

Mesalamine is generally considered safe for use during pregnancy (Pregnancy Category B). Studies in animals have not shown harm to the fetus, and human data suggest low risk. However, it should be used only if clearly needed and the potential benefits outweigh the potential risks.

Mesalamine and its metabolite are excreted in breast milk in low concentrations. Generally considered compatible with breastfeeding. Monitor breastfed infants for signs of diarrhea.

Safety and efficacy of mesalamine 1000mg suppositories have not been established in pediatric patients (under 18 years of age). Other mesalamine formulations (e.g., oral or enema) may be used in pediatric IBD under specialist guidance.

Use with caution in elderly patients, particularly those with pre-existing renal impairment, due to the potential for increased systemic exposure and risk of renal toxicity. Monitor renal function closely.

• Mesalamine suppositories are specifically designed for ulcerative proctitis, targeting inflammation in the rectum and distal sigmoid colon.
• For best results, administer the suppository at bedtime after a bowel movement, and try to retain it for as long as possible, ideally overnight.
• Patients should be advised that the suppository may stain clothing or bedding.
• Regular monitoring of renal function is important, especially in patients with pre-existing kidney disease or those on concomitant nephrotoxic medications.
• Inform patients about the rare but serious acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) and to discontinue the drug and contact their physician if these symptoms occur.

• Other mesalamine formulations (e.g., oral tablets/capsules, enemas, foams)
• Corticosteroids (e.g., hydrocortisone rectal foam/enema, oral prednisone for more extensive disease)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate for more severe or refractory disease)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab for moderate to severe disease)
• Janus kinase (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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.