5 Aminosalicylic Acid (Mesalamine)

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Generic Name of 5 Aminosalicylic Acid (Mesalamine) - Learn More

5 Aminosalicylic Acid (Mesalamine)

5 Aminosalicylic Acid (Mesalamine) Precaution - What You Need to Know

- Allergic Reactions: Before taking mesalamine, inform your doctor if you are allergic to it or to other aminosalicylates (such as balsalazide, olsalazine), salicylates (such as aspirin, salsalate), or sulfasalazine. Mesalamine can cause allergic reactions, including skin rashes, itching, and difficulty breathing. Some formulations may contain inactive ingredients like sulfites, which can also trigger allergic reactions.

- Hypersensitivity Reactions: Mesalamine can cause hypersensitivity reactions, including symptoms such as rash, fever, and joint pain. These reactions can occur even in patients who have previously tolerated the medication. If you experience any symptoms of hypersensitivity, seek immediate medical attention.

- Renal Impairment: Mesalamine should be used with caution in patients with renal impairment. The medication can affect kidney function, leading to conditions such as interstitial nephritis. Regular monitoring of kidney function is essential during treatment with mesalamine. Patients with severe renal impairment should avoid using mesalamine due to the risk of further kidney damage.

- Hepatic Impairment: Mesalamine can affect liver function and should be used cautiously in patients with hepatic impairment. Regular liver function tests are necessary to monitor for signs of liver damage, such as elevated liver enzymes. Patients with severe liver disease should avoid using mesalamine due to the risk of exacerbating liver dysfunction.

- Gastrointestinal Conditions: Mesalamine can worsen existing gastrointestinal conditions, such as gastric or duodenal ulcers. It should be used with caution in patients with a history of gastrointestinal ulcers or obstructions. Mesalamine can also cause pancreatitis, a serious inflammation of the pancreas, which requires immediate medical attention.

- Cardiac Conditions: Mesalamine can cause pericarditis, an inflammation of the sac surrounding the heart. This condition can lead to chest pain, shortness of breath, and other cardiac symptoms. Patients with a history of heart disease should use mesalamine with caution and be monitored closely for signs of pericarditis.

- Blood Disorders: Mesalamine can affect blood cell production, leading to conditions such as anemia, leukopenia, and thrombocytopenia. Regular blood tests are necessary to monitor for changes in blood cell counts. Patients should be aware of symptoms such as fatigue, pale skin, and increased bruising or bleeding.

- Pregnancy and Breastfeeding: Mesalamine is generally considered safe for use during pregnancy and breastfeeding. However, it should be used only if clearly needed and under the supervision of a healthcare provider. Pregnant women should discuss the potential risks and benefits with their doctor before starting mesalamine.

- Sulfa Allergy: Certain formulations of mesalamine may contain sulfites, which can cause allergic reactions in individuals with a sulfa allergy. Patients with a known sulfa allergy should inform their doctor before using mesalamine and may need to consider alternative formulations.

- Acute Intolerance Syndrome: Mesalamine can cause an acute intolerance syndrome, characterized by symptoms such as abdominal pain, diarrhea, and fever. This syndrome can be difficult to differentiate from an exacerbation of ulcerative colitis. If you experience these symptoms, consult your doctor immediately.

- Drug Interactions: Mesalamine can interact with other medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), azathioprine, and mercaptopurine. These interactions can affect the efficacy of mesalamine or increase the risk of side effects. Inform your doctor about all medications you are taking, including prescription, over-the-counter, and herbal supplements.

- Monitoring: Regular monitoring is essential during treatment with mesalamine. This includes blood tests to check for anemia and other blood disorders, liver function tests to monitor for liver damage, and kidney function tests to detect any signs of renal impairment. Patients should also be aware of symptoms that may indicate adverse effects, such as abdominal pain, fever, and skin rashes.

- Administration: Mesalamine is available in various formulations, including oral tablets, delayed-release tablets, and enemas. It is important to follow the prescribed dosage and administration instructions carefully. Do not crush or chew delayed-release tablets, as this can affect the drug's release mechanism. Store mesalamine at room temperature, away from moisture and heat.

- Patient Education: Patients should be educated about the potential side effects of mesalamine and the importance of regular monitoring. They should be advised to report any unusual symptoms to their doctor immediately. Patients should also be aware of the signs of serious adverse effects, such as chest pain, shortness of breath, and severe abdominal pain.

5 Aminosalicylic Acid (Mesalamine) Indication - Uses and Benefits

- Ulcerative Colitis: Mesalamine is primarily indicated for the treatment of ulcerative colitis, a chronic inflammatory bowel disease that affects the colon and rectum. It is effective in inducing and maintaining remission in patients with mild to moderate ulcerative colitis. Mesalamine helps to reduce symptoms such as diarrhea, rectal bleeding, and abdominal pain by decreasing inflammation in the colon.

- Crohn's Disease: While mesalamine is most commonly used for ulcerative colitis, it may also be prescribed for the management of Crohn's disease, another type of inflammatory bowel disease that can affect any part of the gastrointestinal tract. Mesalamine can help to reduce inflammation and alleviate symptoms in patients with mild to moderate Crohn's disease.

- Proctitis and Proctosigmoiditis: Mesalamine is indicated for the treatment of proctitis (inflammation of the rectum) and proctosigmoiditis (inflammation of the rectum and sigmoid colon). These conditions can cause symptoms such as rectal bleeding, diarrhea, and abdominal pain. Mesalamine enemas and suppositories are particularly effective in treating these localized forms of inflammatory bowel disease.

- Acute Uncomplicated Diverticulitis: In some cases, mesalamine may be used to treat acute uncomplicated diverticulitis, a condition characterized by inflammation or infection of small pouches (diverticula) that can form in the colon. Mesalamine can help to reduce inflammation and alleviate symptoms in patients with this condition.

- Maintenance of Remission: Mesalamine is not only used to induce remission in inflammatory bowel diseases but also to maintain remission. Long-term use of mesalamine can help to prevent the recurrence of symptoms and reduce the risk of flare-ups in patients with ulcerative colitis and Crohn's disease.

- Pediatric Use: Mesalamine is approved for use in pediatric patients with ulcerative colitis. It is effective in inducing and maintaining remission in children with mild to moderate ulcerative colitis. The safety and efficacy of mesalamine in pediatric patients have been established, making it a valuable treatment option for managing inflammatory bowel disease in children.

- Off-Label Uses: While not officially approved for these indications, mesalamine may sometimes be prescribed off-label for other inflammatory conditions of the gastrointestinal tract. Its anti-inflammatory properties can be beneficial in managing symptoms of conditions such as microscopic colitis and collagenous colitis.

- Dosage Forms: Mesalamine is available in various dosage forms, including oral tablets, delayed-release tablets, granules, enemas, and suppositories. The choice of dosage form depends on the specific condition being treated and the location of inflammation in the gastrointestinal tract. Oral formulations are typically used for more extensive disease, while enemas and suppositories are used for localized inflammation in the rectum and distal colon.

- Mechanism of Action: Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is an anti-inflammatory medication that belongs to the class of drugs known as aminosalicylates. It works by inhibiting the production of pro-inflammatory cytokines and reducing the activity of inflammatory cells in the gastrointestinal tract. This anti-inflammatory effect helps to alleviate symptoms and promote healing in patients with inflammatory bowel diseases.

- Clinical Efficacy: Numerous clinical studies have demonstrated the efficacy of mesalamine in treating inflammatory bowel diseases. Mesalamine has been shown to be more effective than placebo in inducing and maintaining remission in patients with ulcerative colitis. It is also comparable in efficacy to other aminosalicylates, such as sulfasalazine, but with a better side effect profile.

5 Aminosalicylic Acid (Mesalamine) Contraindications - Important Warnings

- Hypersensitivity: Mesalamine is contraindicated in patients with known hypersensitivity to mesalamine, other aminosalicylates (such as balsalazide, olsalazine), salicylates (such as aspirin, salsalate), or sulfasalazine. Hypersensitivity reactions can include symptoms such as rash, itching, swelling, and difficulty breathing.

- Severe Renal Impairment: Mesalamine should not be used in patients with severe renal impairment. The medication can affect kidney function and may exacerbate existing kidney problems, leading to conditions such as interstitial nephritis. Patients with severe renal impairment are at increased risk of further kidney damage.

- Severe Hepatic Impairment: Mesalamine is contraindicated in patients with severe hepatic impairment. The medication can affect liver function and may worsen existing liver disease. Patients with severe liver impairment are at increased risk of liver damage, including elevated liver enzymes and hepatitis.

- Urinary Tract Obstruction: Mesalamine should not be used in patients with urinary tract obstruction. The medication can exacerbate urinary retention and may lead to further complications, including kidney damage.

- Gastric or Duodenal Ulcers: Mesalamine is contraindicated in patients with existing gastric or duodenal ulcers. The medication can worsen these conditions and may lead to complications such as perforation and bleeding.

- Pyloric Stenosis: Mesalamine should not be used in patients with pyloric stenosis, a condition that causes narrowing of the opening between the stomach and the small intestine. The medication can exacerbate symptoms of pyloric stenosis and may lead to further complications.

- Infants: Mesalamine is not recommended for use in infants. The safety and efficacy of the medication in this age group have not been established, and infants may be more susceptible to adverse effects.

- Acute Intolerance Syndrome: Mesalamine can cause an acute intolerance syndrome, characterized by symptoms such as abdominal pain, diarrhea, and fever. This syndrome can be difficult to differentiate from an exacerbation of ulcerative colitis. Patients who develop acute intolerance syndrome should discontinue mesalamine and seek immediate medical attention.

- Pregnancy and Breastfeeding: While mesalamine is generally considered safe for use during pregnancy and breastfeeding, it should be used only if clearly needed and under the supervision of a healthcare provider. Pregnant women should discuss the potential risks and benefits with their doctor before starting mesalamine.

- Sulfa Allergy: Certain formulations of mesalamine may contain sulfites, which can cause allergic reactions in individuals with a sulfa allergy. Patients with a known sulfa allergy should inform their doctor before using mesalamine and may need to consider alternative formulations.

- Concomitant Use of Certain Medications: Mesalamine can interact with other medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), azathioprine, and mercaptopurine. These interactions can affect the efficacy of mesalamine or increase the risk of side effects. Patients should inform their doctor about all medications they are taking, including prescription, over-the-counter, and herbal supplements.

5 Aminosalicylic Acid (Mesalamine) Side Effects - What to Expect

- Gastrointestinal Side Effects: Mesalamine can cause various gastrointestinal side effects, including diarrhea, abdominal pain, nausea, and vomiting. These side effects are usually mild and transient, but they can be more severe in some patients. Rarely, mesalamine can worsen ulcerative colitis, leading to increased symptoms such as bloody diarrhea and abdominal cramps.

- Hepatic Side Effects: Mesalamine can affect liver function, leading to conditions such as hepatitis, elevated liver enzymes, and jaundice. Regular liver function tests are necessary to monitor for signs of liver damage. Patients should be aware of symptoms such as fatigue, loss of appetite, dark urine, and yellowing of the skin or eyes, which may indicate liver problems.

- Renal Side Effects: Mesalamine can affect kidney function, leading to conditions such as interstitial nephritis and renal failure. Regular kidney function tests are essential to monitor for signs of renal impairment. Patients should be aware of symptoms such as decreased urine output, swelling in the extremities, and fatigue, which may indicate kidney problems.

- Hematologic Side Effects: Mesalamine can affect blood cell production, leading to conditions such as anemia, leukopenia, and thrombocytopenia. Regular blood tests are necessary to monitor for changes in blood cell counts. Patients should be aware of symptoms such as fatigue, pale skin, and increased bruising or bleeding, which may indicate blood disorders.

- Dermatologic Side Effects: Mesalamine can cause various skin reactions, including rash, itching, and hives. These reactions can be mild or severe, and in some cases, they may be part of a more extensive hypersensitivity reaction. Patients should be aware of any changes in their skin and report them to their doctor.

- Cardiac Side Effects: Mesalamine can cause pericarditis, an inflammation of the sac surrounding the heart. This condition can lead to chest pain, shortness of breath, and other cardiac symptoms. Patients should be aware of any chest discomfort or difficulty breathing and report them to their doctor immediately.

- Respiratory Side Effects: Mesalamine can cause respiratory side effects, including shortness of breath, cough, and wheezing. These symptoms can be part of a hypersensitivity reaction or may indicate other respiratory issues. Patients should report any respiratory symptoms to their doctor.

- Neurologic Side Effects: Mesalamine can cause neurologic side effects, including headache, dizziness, and peripheral neuropathy. Peripheral neuropathy is a condition that affects the nerves in the extremities, leading to symptoms such as numbness, tingling, and weakness. Patients should report any neurologic symptoms to their doctor.

- Musculoskeletal Side Effects: Mesalamine can cause musculoskeletal side effects, including joint pain, muscle pain, and back pain. These symptoms can be mild or severe and may require medical attention. Patients should report any musculoskeletal symptoms to their doctor.

- Hypersensitivity Reactions: Mesalamine can cause hypersensitivity reactions, which can include symptoms such as rash, fever, and joint pain. These reactions can occur even in patients who have previously tolerated the medication. If you experience any symptoms of hypersensitivity, seek immediate medical attention.

- Acute Intolerance Syndrome: Mesalamine can cause an acute intolerance syndrome, characterized by symptoms such as abdominal pain, diarrhea, and fever. This syndrome can be difficult to differentiate from an exacerbation of ulcerative colitis. If you experience these symptoms, consult your doctor immediately.

- Pancreatitis: Mesalamine can cause pancreatitis, a serious inflammation of the pancreas that requires immediate medical attention. Symptoms of pancreatitis include severe abdominal pain, nausea, vomiting, and fever. Patients should be aware of these symptoms and seek medical help if they occur.

- Monitoring: Regular monitoring is essential during treatment with mesalamine to detect and manage potential side effects. This includes blood tests to check for anemia and other blood disorders, liver function tests to monitor for liver damage, and kidney function tests to detect any signs of renal impairment. Patients should also be aware of symptoms that may indicate adverse effects, such as abdominal pain, fever, and skin rashes.

- Patient Education: Patients should be educated about the potential side effects of mesalamine and the importance of regular monitoring. They should be advised to report any unusual symptoms to their doctor immediately. Patients should also be aware of the signs of serious adverse effects, such as chest pain, shortness of breath, and severe abdominal pain.

5 Aminosalicylic Acid (Mesalamine) Pregnancy Category ID - Safety Information

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5 Aminosalicylic Acid (Mesalamine) Mode of Action - How It Works

- Anti-Inflammatory Effects: Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is an anti-inflammatory medication that belongs to the class of drugs known as aminosalicylates. It works by inhibiting the production of pro-inflammatory cytokines, such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α), which are involved in the inflammatory response in the gastrointestinal tract.

- Inhibition of Cyclooxygenase and Lipoxygenase: Mesalamine inhibits the activity of cyclooxygenase (COX) and lipoxygenase (LOX) enzymes, which are involved in the production of prostaglandins and leukotrienes, respectively. These mediators contribute to inflammation and tissue damage in the gastrointestinal tract. By inhibiting COX and LOX, mesalamine reduces the production of prostaglandins and leukotrienes, thereby decreasing inflammation.

- Scavenging of Reactive Oxygen Species: Mesalamine acts as a scavenger of reactive oxygen species (ROS), which are produced during the inflammatory response and can cause tissue damage. By scavenging ROS, mesalamine helps to protect the gastrointestinal mucosa from oxidative stress and reduces inflammation.

- Inhibition of Nuclear Factor-kappa B (NF-κB): Mesalamine inhibits the activation of NF-κB, a transcription factor that plays a crucial role in the inflammatory response. NF-κB regulates the expression of various pro-inflammatory genes, including those encoding cytokines, chemokines, and adhesion molecules. By inhibiting NF-κB, mesalamine reduces the expression of pro-inflammatory genes and decreases inflammation.

- Inhibition of Leukocyte Activation and Adhesion: Mesalamine inhibits the activation and adhesion of leukocytes, which are white blood cells involved in the inflammatory response. By inhibiting leukocyte activation and adhesion, mesalamine reduces the infiltration of inflammatory cells into the gastrointestinal mucosa and decreases tissue damage.

- Inhibition of Matrix Metalloproteinases (MMPs): Mesalamine inhibits the activity of MMPs, which are enzymes involved in the degradation of the extracellular matrix. MMPs contribute to tissue damage and inflammation in the gastrointestinal tract. By inhibiting MMPs, mesalamine helps to preserve the integrity of the gastrointestinal mucosa and reduces inflammation.

- Modulation of Intestinal Microbiota: Mesalamine can modulate the composition and function of the intestinal microbiota, which plays a role in the pathogenesis of inflammatory bowel diseases. By promoting the growth of beneficial bacteria and inhibiting the growth of pathogenic bacteria, mesalamine helps to restore a healthy microbiota and reduces inflammation.

- Immunomodulatory Effects: Mesalamine has immunomodulatory effects, which means it can modulate the activity of the immune system. By inhibiting the activation and proliferation of T cells, which are involved in the inflammatory response, mesalamine helps to reduce inflammation and promote immune tolerance.

- Topical vs. Systemic Effects: Mesalamine exerts its anti-inflammatory effects primarily at the site of inflammation in the gastrointestinal tract, with minimal systemic absorption. This localized action helps to minimize systemic side effects and maximize therapeutic efficacy. Mesalamine is available in various formulations, including oral tablets, delayed-release tablets, granules, enemas, and suppositories, which allow for targeted delivery to the site of inflammation.

- Clinical Efficacy: Numerous clinical studies have demonstrated the efficacy of mesalamine in treating inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease. Mesalamine has been shown to be more effective than placebo in inducing and maintaining remission in patients with mild to moderate ulcerative colitis. It is also comparable in efficacy to other aminosalicylates, such as sulfasalazine, but with a better side effect profile.

5 Aminosalicylic Acid (Mesalamine) Drug Interactions - What to Avoid

- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Concomitant use of mesalamine with NSAIDs can increase the risk of gastrointestinal side effects, such as ulcers and bleeding. NSAIDs can also exacerbate inflammatory bowel disease symptoms and may reduce the effectiveness of mesalamine.

- Azathioprine and Mercaptopurine: Mesalamine can interact with immunosuppressant medications such as azathioprine and mercaptopurine, which are often used to treat inflammatory bowel diseases. Concomitant use of these medications with mesalamine can increase the risk of bone marrow suppression, leading to conditions such as anemia, leukopenia, and thrombocytopenia.

- Sulfasalazine: Mesalamine is structurally related to sulfasalazine, and patients who are allergic to sulfasalazine may also be allergic to mesalamine. Concomitant use of these medications should be avoided due to the risk of cross-reactivity and increased side effects.

- Salicylates: Mesalamine is an aminosalicylate, and patients who are allergic to salicylates (such as aspirin) may also be allergic to mesalamine. Concomitant use of mesalamine with salicylates should be avoided due to the risk of cross-reactivity and increased side effects.

- Anticoagulants: Mesalamine can interact with anticoagulant medications, such as warfarin, increasing the risk of bleeding. Patients taking anticoagulants should be closely monitored for signs of bleeding and may require dose adjustments of their anticoagulant medication.

- Digoxin: Mesalamine can interact with digoxin, a medication used to treat heart failure and abnormal heart rhythms. Concomitant use of mesalamine with digoxin can increase the risk of digoxin toxicity, leading to symptoms such as nausea, vomiting, and arrhythmias.

- Antacids: Antacids containing aluminum or magnesium can interact with mesalamine, reducing its absorption and effectiveness. Patients should avoid taking antacids within two hours of taking mesalamine to prevent this interaction.

- Probenecid: Probenecid, a medication used to treat gout, can interact with mesalamine by increasing its plasma concentration. This interaction can enhance the therapeutic effects of mesalamine but also increase the risk of side effects. Patients taking probenecid should be closely monitored for adverse effects.

- Alcohol: Alcohol can interact with mesalamine, increasing the risk of gastrointestinal side effects and reducing the effectiveness of the medication. Patients should avoid consuming alcohol while taking mesalamine to prevent this interaction.

- Herbal Supplements: Certain herbal supplements, such as St. John's wort, can interact with mesalamine by affecting its metabolism and reducing its effectiveness. Patients should inform their doctor about all herbal supplements they are taking to avoid potential interactions.

- Drug-Food Interactions: Mesalamine should be taken with food to reduce the risk of gastrointestinal side effects, such as nausea and abdominal pain. Taking mesalamine with food can also enhance its absorption and effectiveness.

- Drug-Laboratory Test Interactions: Mesalamine can interfere with certain laboratory tests, including tests for urinary normetanephrine. Patients should inform their healthcare provider about their use of mesalamine before undergoing laboratory tests to avoid misinterpretation of results.

- Monitoring: Regular monitoring is essential during treatment with mesalamine, especially when used in combination with other medications. This includes blood tests to check for anemia and other blood disorders, liver function tests to monitor for liver damage, and kidney function tests to detect any signs of renal impairment. Patients should also be aware of symptoms that may indicate adverse effects, such as abdominal pain, fever, and skin rashes.

- Patient Education: Patients should be educated about the potential interactions of mesalamine with other medications and the importance of regular monitoring. They should be advised to report any unusual symptoms to their doctor immediately. Patients should also be aware of the signs of serious adverse effects, such as chest pain, shortness of breath, and severe abdominal pain.

5 Aminosalicylic Acid (Mesalamine) Adult Dose - Recommended Dosage

- Oral Formulations:
- Delayed-Release Tablets: The typical adult dose for delayed-release mesalamine tablets is 2.4 to 4.8 grams per day, divided into two or three doses. These tablets are designed to release the medication in the terminal ileum and colon, where it exerts its anti-inflammatory effects. The delayed-release formulation helps to minimize systemic absorption and reduce side effects.
- Extended-Release Tablets: The recommended adult dose for extended-release mesalamine tablets is 1.5 grams once daily. This formulation is designed to provide a steady release of the medication over a 24-hour period, which can help to maintain consistent therapeutic levels and reduce the frequency of dosing.
- Granules: Mesalamine granules are available in packets containing 1 gram or 1.5 grams of the medication. The typical adult dose is 1 to 4 packets per day, taken with food. The granules should be mixed with a small amount of water or yogurt and swallowed without chewing to ensure proper release of the medication in the gastrointestinal tract.

- Rectal Formulations:
- Enemas: Mesalamine enemas are typically administered once daily at bedtime. The usual adult dose is 4 grams per day, retained in the rectum for approximately 8 hours. Enemas are particularly effective in treating distal ulcerative colitis, proctosigmoiditis, and proctitis, as they deliver the medication directly to the site of inflammation.
- Suppositories: Mesalamine suppositories are usually administered once or twice daily. The typical adult dose is 500 mg to 1 gram per day, inserted into the rectum and retained for as long as possible. Suppositories are useful for treating localized inflammation in the rectum and distal colon.

- Dosage Adjustments:
- Renal Impairment: In patients with mild to moderate renal impairment, no dosage adjustment is typically required. However, patients with severe renal impairment should use mesalamine with caution, and lower doses may be necessary to avoid further kidney damage. Regular monitoring of kidney function is essential in these patients.
- Hepatic Impairment: In patients with mild to moderate hepatic impairment, no dosage adjustment is typically required. However, patients with severe liver disease should use mesalamine with caution, and lower doses may be necessary to avoid exacerbating liver dysfunction. Regular monitoring of liver function is essential in these patients.

- Administration:
- Timing: Mesalamine should be taken at the same time(s) each day to maintain consistent therapeutic levels. Oral formulations can be taken with or without food, but taking them with food can help to reduce gastrointestinal side effects. Rectal formulations should be administered at bedtime to ensure retention of the medication in the rectum.
- Storage: Mesalamine should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It can be exposed to temperatures between 59°F to 86°F (15°C to 30°C) for shorter periods, such as during transportation. Keep the medication away from moisture and heat.

- Monitoring:
- Regular monitoring is essential during treatment with mesalamine to detect and manage potential side effects. This includes blood tests to check for anemia and other blood disorders, liver function tests to monitor for liver damage, and kidney function tests to detect any signs of renal impairment. Patients should also be aware of symptoms that may indicate adverse effects, such as abdominal pain, fever, and skin rashes.

- Patient Education:
- Patients should be educated about the proper use of mesalamine, including the importance of taking the medication as prescribed and the potential side effects. They should be advised to report any unusual symptoms to their doctor immediately. Patients should also be aware of the signs of serious adverse effects, such as chest pain, shortness of breath, and severe abdominal pain.

5 Aminosalicylic Acid (Mesalamine) Child Dose - Dosage for Children

- Oral Formulations:
- Delayed-Release Tablets: The typical pediatric dose for delayed-release mesalamine tablets is 30 to 50 mg/kg per day, divided into two or three doses. These tablets are designed to release the medication in the terminal ileum and colon, where it exerts its anti-inflammatory effects. The delayed-release formulation helps to minimize systemic absorption and reduce side effects.
- Extended-Release Tablets: The recommended pediatric dose for extended-release mesalamine tablets is 30 to 50 mg/kg per day, taken once daily. This formulation is designed to provide a steady release of the medication over a 24-hour period, which can help to maintain consistent therapeutic levels and reduce the frequency of dosing.
- Granules: Mesalamine granules are available in packets containing 1 gram or 1.5 grams of the medication. The typical pediatric dose is 30 to 50 mg/kg per day, taken with food. The granules should be mixed with a small amount of water or yogurt and swallowed without chewing to ensure proper release of the medication in the gastrointestinal tract.

- Rectal Formulations:
- Enemas: Mesalamine enemas are typically administered once daily at bedtime. The usual pediatric dose is 1 to 2 grams per day, retained in the rectum for approximately 8 hours. Enemas are particularly effective in treating distal ulcerative colitis, proctosigmoiditis, and proctitis, as they deliver the medication directly to the site of inflammation.
- Suppositories: Mesalamine suppositories are usually administered once or twice daily. The typical pediatric dose is 250 mg to 500 mg per day, inserted into the rectum and retained for as long as possible. Suppositories are useful for treating localized inflammation in the rectum and distal colon.

- Dosage Adjustments:
- Renal Impairment: In pediatric patients with mild to moderate renal impairment, no dosage adjustment is typically required. However, patients with severe renal impairment should use mesalamine with caution, and lower doses may be necessary to avoid further kidney damage. Regular monitoring of kidney function is essential in these patients.
- Hepatic Impairment: In pediatric patients with mild to moderate hepatic impairment, no dosage adjustment is typically required. However, patients with severe liver disease should use mesalamine with caution, and lower doses may be necessary to avoid exacerbating liver dysfunction. Regular monitoring of liver function is essential in these patients.

- Administration:
- Timing: Mesalamine should be taken at the same time(s) each day to maintain consistent therapeutic levels. Oral formulations can be taken with or without food, but taking them with food can help to reduce gastrointestinal side effects. Rectal formulations should be administered at bedtime to ensure retention of the medication in the rectum.
- Storage: Mesalamine should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It can be exposed to temperatures between 59°F to 86°F (15°C to 30°C) for shorter periods, such as during transportation. Keep the medication away from moisture and heat.

- Monitoring:
- Regular monitoring is essential during treatment with mesalamine to detect and manage potential side effects. This includes blood tests to check for anemia and other blood disorders, liver function tests to monitor for liver damage, and kidney function tests to detect any signs of renal impairment. Pediatric patients should also be monitored for growth and development, as chronic inflammation and medication use can affect these parameters.

- Patient Education:
- Parents and caregivers should be educated about the proper use of mesalamine, including the importance of taking the medication as prescribed and the potential side effects. They should be advised to report any unusual symptoms to their doctor immediately. Parents and caregivers should also be aware of the signs of serious adverse effects, such as chest pain, shortness of breath, and severe abdominal pain.

- Special Considerations:
- Mesalamine is approved for use in pediatric patients with ulcerative colitis. It is effective in inducing and maintaining remission in children with mild to moderate ulcerative colitis. The safety and efficacy of mesalamine in pediatric patients have been established, making it a valuable treatment option for managing inflammatory bowel disease in children.
- Pediatric patients with ulcerative colitis may require higher doses of mesalamine, depending on the severity of their disease and their response to the medication. Dose adjustments should be made based on individual tolerance and response to the medication, and close monitoring is essential to manage potential side effects.

5 Aminosalicylic Acid (Mesalamine) Renal Dose - Dosage for Kidney Conditions

- Mild to Moderate Renal Impairment:
- For patients with mild to moderate renal impairment (creatinine clearance 30 to 89 mL/min), no dosage adjustment is typically required. However, these patients should be monitored closely for any signs of adverse effects, as the clearance of mesalamine and its metabolites may be reduced. Regular kidney function tests are essential to detect any changes in renal function.

- Severe Renal Impairment:
- For patients with severe renal impairment (creatinine clearance less than 30 mL/min), lower doses of mesalamine may be necessary to avoid further kidney damage. The initial dose should be reduced, and dose titration should be done cautiously, with close monitoring for adverse effects. Regular kidney function tests are crucial in these patients to detect any signs of worsening renal impairment.

- End-Stage Renal Disease (ESRD):
- Patients with end-stage renal disease (ESRD) requiring dialysis should be managed with extreme caution. Mesalamine and its metabolites may accumulate in these patients, leading to increased side effects. Lower doses may be necessary, and dose adjustments should be made based on individual tolerance and response to the medication. Regular monitoring of kidney function is essential in these patients.

- Dialysis:
- Mesalamine is not significantly removed by dialysis. Therefore, patients undergoing dialysis should be monitored closely for adverse effects, and dose adjustments should be made as necessary. Supplemental doses after dialysis are generally not required. Regular kidney function tests are essential to detect any changes in renal function.

- Monitoring:
- Regular monitoring is essential in patients with renal impairment to detect and manage potential adverse effects. This includes blood tests to check for anemia and other blood disorders, liver function tests to monitor for liver damage, and kidney function tests to detect any signs of worsening renal impairment. Patients should also be aware of symptoms that may indicate adverse effects, such as abdominal pain, fever, and skin rashes.

- Hydration:
- Patients with renal impairment should be advised to maintain adequate hydration to support kidney function. This can help to minimize the risk of adverse effects and support the clearance of mesalamine and its metabolites. Adequate hydration is particularly important in patients with severe renal impairment or ESRD.

- Concomitant Medications:
- Patients with renal impairment may be taking other medications that can affect renal function or interact with mesalamine. It is important to review all concomitant medications and consult with a healthcare provider to avoid potential drug interactions and adverse effects. Regular monitoring of kidney function is essential in these patients.

- Alternative Formulations:
- For patients with severe renal impairment or ESRD, alternative formulations of mesalamine, such as enemas or suppositories, may be considered. These formulations can provide a more targeted delivery of the medication to the site of inflammation and may be better tolerated in patients with renal impairment. Regular monitoring of kidney function is essential in these patients.

- Special Considerations:
- Elderly patients with renal impairment may be at increased risk of adverse effects, particularly cognitive impairment and sedation. Lower starting doses and slower dose titration may be necessary to minimize these side effects. Regular monitoring of kidney function is essential in these patients.

- Administration:
- Mesalamine should be taken at the same time(s) each day to maintain consistent therapeutic levels. Oral formulations can be taken with or without food, but taking them with food can help to reduce gastrointestinal side effects. Rectal formulations should be administered at bedtime to ensure retention of the medication in the rectum. Patients with renal impairment should follow their healthcare provider's instructions regarding the administration of mesalamine.