Rowasa 4gm Kit (7 X 60ml)

Mesalamine (5-aminosalicylic acid, 5-ASA) is thought to exert its anti-inflammatory effects locally in the colon. Its exact mechanism is not fully understood but is believed to involve inhibition of cyclooxygenase and lipoxygenase pathways, thereby reducing 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, 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
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden 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, or sore throat
Unexplained bruising or bleeding
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, characterized by:
+ 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, characterized by:
+ 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, which can affect body organs and be life-threatening
+ Signs 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 concern you, contact your doctor:

Constipation
Diarrhea
Stomach pain
Nausea or 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 your stomach valve or other types of stomach blockages
+ Blockages in your 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 any 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

Be aware that this medication may affect the results of certain lab tests. 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 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 is 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. Avoid exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk of sunburn.

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 your doctor before giving this medication to a child. 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 rare but serious condition that can cause brain and liver damage.

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

• NSAIDs (e.g., ibuprofen, naproxen)
• Nephrotoxic agents (e.g., aminoglycosides, cyclosporine)

• Rectal bleeding
• Abdominal pain
• Diarrhea
• Fever
• Rash
• Headache
• Nausea/vomiting
• Signs of worsening ulcerative colitis
• Signs of renal impairment (e.g., decreased urine output, edema)
• Signs of hepatic impairment (e.g., jaundice, dark urine, fatigue)
• Signs of blood dyscrasias (e.g., unusual bruising/bleeding, persistent sore throat, fever)

Mesalamine is generally considered safe for use during pregnancy (Pregnancy Category B). Studies in pregnant women have not shown an increased risk of birth defects or other adverse outcomes. Rectal administration results in minimal systemic absorption, further reducing potential fetal exposure.

Mesalamine and its metabolite are excreted in breast milk in small amounts. The amount transferred to the infant is generally considered low and unlikely to cause adverse effects. Monitor breastfed infants for diarrhea.

Safety and efficacy of Rowasa enema have not been established in pediatric patients. Use in children is off-label and should be done under the guidance of a specialist, with careful consideration of dose and monitoring.

Use with caution in elderly patients, as they may have age-related decreases in renal function. Monitor renal function closely. No specific dose adjustment is typically required unless renal impairment is present.

• Rowasa enema is designed for local action in the rectum and distal colon; systemic absorption is minimal.
• For best results, administer at bedtime and try to retain the enema for at least 8 hours.
• Patients should be instructed on proper administration technique to ensure maximum retention and efficacy.
• Mesalamine can rarely cause acute intolerance syndrome, which may mimic a flare of inflammatory bowel disease (e.g., cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash). If this occurs, discontinue therapy immediately.
• Rare cases of renal impairment, including minimal change nephropathy and interstitial nephritis, have been reported with mesalamine. Regular monitoring of renal function is important.

• Other mesalamine formulations (oral tablets/capsules, suppositories, foam enemas)
• Corticosteroids (e.g., hydrocortisone rectal foam/enema, oral prednisone)
• Immunomodulators (e.g., azathioprine, mercaptopurine)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab)
• 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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.