Pentasa 500mg Capsules

Mesalamine (5-aminosalicylic acid or 5-ASA) is thought to exert its anti-inflammatory effects locally in the intestinal mucosa. While the exact mechanism is not fully elucidated, it is believed to modulate inflammatory responses by inhibiting cyclooxygenase and lipoxygenase pathways, thereby decreasing the production of prostaglandins and leukotrienes. It may also scavenge free radicals, inhibit cytokine production, and modulate immune cell function.

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 or seek immediate 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 pass urine
+ 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
New or worsening stomach pain or cramps, bloody stools, fever, headache, itching, rash, red or pink eyes, or general feeling of illness (may resemble ulcerative colitis symptoms)
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of heart problems, including:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may also affect internal organs
+ Symptoms 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 experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Gas
Burping
Nose or throat irritation
Dizziness
Headache
Back pain
Cough

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 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 existing health conditions and medications.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

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.

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 comes into contact with any surfaces or water, please contact your doctor.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to safeguard your skin and eyes 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 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 rare but serious condition that can cause severe brain and liver damage.

If you are pregnant, planning to become pregnant, or 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
• Thiopurines (increased risk of myelosuppression)
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (increased risk of nephrotoxicity)

• Warfarin (potential for increased INR/bleeding)
• Lactulose (may interfere with mesalamine release)
• Drugs that alter gastric pH (e.g., antacids, PPIs - may affect dissolution of some mesalamine formulations, but less relevant for Pentasa's pH-independent release)

• Worsening abdominal pain or cramping
• Bloody diarrhea
• Fever
• Rash
• Unexplained fatigue or weakness
• Nausea or vomiting
• Dark urine or yellowing of skin/eyes (jaundice)
• Decreased urine output or swelling (signs of kidney problems)
• Chest pain or shortness of breath (rare, but possible cardiac hypersensitivity)

Mesalamine is generally considered low risk during pregnancy. Studies in pregnant women have not shown an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, use should be based on a careful risk-benefit assessment, as uncontrolled inflammatory bowel disease can pose greater risks to pregnancy outcomes.

Mesalamine and its metabolite are excreted in breast milk in small amounts. While generally considered compatible with breastfeeding, caution is advised. Monitor breastfed infants for signs of diarrhea.

Pentasa capsules are not FDA-approved for pediatric use, but mesalamine is commonly used off-label in children for ulcerative colitis. Dosing is typically weight-based. Close monitoring for adverse effects, especially renal and hepatic function, is crucial.

Use with caution in elderly patients, as they are more likely to have decreased renal function. Monitor renal function closely. Start at the lower end of the dosing range.

• Pentasa capsules contain microgranules that are designed to release mesalamine throughout the entire GI tract (pH-independent release), making it suitable for both ulcerative colitis and Crohn's disease.
• Patients should swallow the capsules whole. If swallowing is difficult, the capsules can be opened and the contents sprinkled on applesauce or yogurt and consumed immediately.
• Adherence is crucial for maintaining remission in IBD. Emphasize the importance of consistent daily dosing.
• Mesalamine can cause an acute intolerance syndrome, which mimics a flare of IBD (cramping, abdominal pain, bloody diarrhea, fever, headache, rash). If this occurs, discontinue the drug immediately.
• Rare but serious adverse effects include nephrotoxicity, hepatotoxicity, and blood dyscrasias. Regular monitoring of renal, hepatic, and hematologic parameters is important.

• Other oral mesalamine formulations (e.g., Lialda, Apriso, Asacol HD, Delzicol - differ in release mechanism and site of action)
• Rectal mesalamine (suppositories, enemas) for distal colitis
• Corticosteroids (e.g., prednisone, budesonide) for induction of remission
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• 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's a good idea to check with your pharmacist. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.