Apriso 0.375gm Capsules

Mesalamine is an aminosalicylate that exerts its therapeutic effect locally in the colonic mucosa. Its exact mechanism is not fully understood but is thought to involve modulation of inflammatory mediators (e.g., leukotrienes, prostaglandins), inhibition of cytokine production, and scavenging of free radicals. It reduces inflammation in the colon, which is characteristic of ulcerative colitis.

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 or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
+ Back pain, abdominal pain, or blood in the urine (which may indicate a kidney stone)
Chest pain or pressure, rapid 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 or rash
+ Red or pink eyes
+ Feeling unwell
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
Signs of heart problems, which can be rare but potentially life-threatening:
+ Shortness of breath
+ Significant 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor for advice:

Constipation
Diarrhea
Stomach pain or upset stomach
Vomiting
Heartburn
Gas
Burping
Nose or throat irritation
Dizziness or headache
Back pain
* Cough

This list is not exhaustive, and you may experience other side effects not mentioned here. 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. Describe the symptoms you experienced during an allergic reaction.
Existing 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)
Other medications you are taking, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Other health problems you are experiencing

This list is not exhaustive, and it is crucial to discuss all your medications and health issues with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dosage of any medication without consulting your doctor first.

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.

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products may contain phenylalanine.

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 notice that your urine is reddish-brown before it comes into contact with any surfaces or water that may have been treated with bleach, 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, 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 formulations of this medication are suitable for children. Before giving this medication 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, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication with you and determine the best course of treatment for you and your baby.

• Azathioprine
• Mercaptopurine

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

• Worsening of ulcerative colitis symptoms (e.g., increased abdominal pain, diarrhea, rectal bleeding)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet)
• Signs of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, severe abdominal pain)
• Signs of blood dyscrasias (e.g., unexplained bleeding, bruising, purpura, sore throat, fever, malaise)
• Signs of hypersensitivity reactions (e.g., rash, fever, difficulty breathing, chest pain, pericarditis, myocarditis, lupus-like syndrome)
• Signs of acute intolerance syndrome (e.g., cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash)

Mesalamine crosses the placenta. While generally considered low risk, use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Uncontrolled inflammatory bowel disease poses greater risks to pregnancy outcomes than mesalamine exposure.

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

Apriso is approved for maintenance of remission of ulcerative colitis in pediatric patients 10 years of age and older. Safety and effectiveness in pediatric patients younger than 10 years have not been established.

Use with caution in elderly patients, as they are more likely to have decreased renal function. Monitor renal function closely. No specific dose adjustment is typically required based on age alone, but individual assessment is crucial.

• Apriso is an extended-release formulation of mesalamine designed for once-daily dosing, which can improve patient adherence.
• It is indicated for the maintenance of remission of ulcerative colitis, not for the treatment of acute flares.
• Patients should be instructed to swallow the capsules whole and not to chew, crush, or break them, as this would alter the extended-release properties.
• Mesalamine can rarely cause an acute intolerance syndrome, which may mimic a flare of ulcerative colitis (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash). If this occurs, discontinue the drug and evaluate the patient.
• Regular monitoring of renal function is important due to the potential for mesalamine-induced nephrotoxicity, especially in patients with pre-existing renal impairment or those taking other nephrotoxic drugs.

• Other oral mesalamine formulations (e.g., Lialda, Asacol HD, Pentasa, sulfasalazine)
• Rectal mesalamine formulations (e.g., Canasa suppositories, Rowasa enema) 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, upadacitinib)

If your symptoms or health issues persist or worsen, it is 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 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.