Mesalamine Delayed Release Tablets USP 400 Mg Tablet

What is Mesalamine Delayed Release Tablets USP 400 Mg Tablet?

Mesalamine Delayed Release Tablets USP 400 mg are an oral formulation containing mesalamine, an aminosalicylate anti-inflammatory medicine. It is used in the management of inflammatory bowel diseases, particularly ulcerative colitis. The delayed-release tablet is designed to deliver mesalamine to the gastrointestinal tract according to the approved product formulation.

Uses / Indications

Mesalamine delayed-release tablets may be used in the management of:

• Mild to moderate ulcerative colitis
• Active ulcerative colitis where mesalamine treatment is indicated
• Maintenance of remission in ulcerative colitis, depending on the approved indication and product information

The specific indication and treatment regimen depend on disease severity, affected gastrointestinal region, formulation characteristics, and approved prescribing information.

Benefits

• Provides local anti-inflammatory activity in the gastrointestinal tract.
• Used in the management of ulcerative colitis.
• May be used during active disease and, for appropriate formulations, to help maintain remission.
• Delayed-release formulation supports delivery of mesalamine to the intended gastrointestinal region.
• Available as a 400 mg delayed-release tablet.

Side Effects

Common Side Effects

Possible adverse effects may include:

• Headache
• Abdominal pain or discomfort
• Nausea
• Diarrhoea
• Flatulence
• Dyspepsia
• Back pain

Less Common or Serious Side Effects

Clinically important reactions may include:

• Acute intolerance reactions resembling an inflammatory bowel disease flare
• Severe abdominal pain
• Pancreatitis
• Hepatitis or other liver-related abnormalities
• Interstitial nephritis or other kidney impairment
• Blood disorders
• Myocarditis or pericarditis
• Severe hypersensitivity or allergic reactions
• Severe skin reactions

Medical attention should be sought if severe abdominal symptoms, unexplained fever, chest pain, breathing difficulty, reduced urine output, severe rash, or other significant symptoms develop.

How Does It Work?

Mesalamine

Mesalamine, also known as 5-aminosalicylic acid or 5-ASA, acts primarily within the intestinal mucosa to reduce inflammatory activity. Its effects involve modulation of inflammatory mediators and pathways associated with intestinal inflammation.

The delayed-release formulation is designed to release mesalamine in the gastrointestinal tract in accordance with the formulation’s release characteristics, helping provide local anti-inflammatory activity at the intended site.

Dosage Guidelines

The appropriate dose and treatment duration depend on the indication, disease severity, gastrointestinal involvement, response to treatment, kidney function, liver function, and the specific delayed-release formulation.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For delayed-release tablets:

• Take exactly as prescribed.
• Swallow the tablet whole with sufficient water unless otherwise directed.
• Do not crush, chew, or break the delayed-release tablet unless specifically permitted by the approved product information.
• Follow the prescribed treatment schedule consistently.
• Do not change the dose without professional advice.

Renal function may require assessment before and during treatment, particularly in patients with risk factors for kidney impairment.

When Not to Use

Mesalamine should generally not be used in patients with:

• Known hypersensitivity to mesalamine or any component of the formulation
• Known hypersensitivity to salicylates or related medicines where contraindicated by the approved product information
• Severe renal impairment unless specifically determined appropriate by a healthcare professional

Medical advice is particularly important for patients with:

• Kidney disease
• Liver disease
• Previous blood disorders associated with medicines
• Gastrointestinal obstruction or significant gastrointestinal motility problems
• A history of hypersensitivity reactions to salicylates or aminosalicylates

Drug / Product Interactions

Clinically relevant interactions may occur with medicines that affect kidney function, blood clotting, or gastrointestinal toxicity.

Particular attention may be required when mesalamine is used with:

• Non-steroidal anti-inflammatory drugs
• Nephrotoxic medicines
• Azathioprine
• 6-mercaptopurine
• Thioguanine
• Anticoagulants such as warfarin
• Other medicines affecting renal function

Patients taking multiple medicines should inform their healthcare professional before starting mesalamine.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Missed Dose

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose unless specifically instructed by a healthcare professional.

Pregnancy

Mesalamine should be used during pregnancy only when clinically indicated and following appropriate medical assessment.

Breastfeeding

Mesalamine and its metabolites may be present in breast milk. The potential benefits and risks should be discussed with a qualified healthcare professional before use during breastfeeding.

Children

Paediatric use should follow the age-specific recommendations of the approved product information and healthcare professional.

Elderly Patients

Older patients may require particular attention to kidney function and concomitant medicines because the risk of renal impairment may increase with age.

Renal Impairment

Mesalamine can affect kidney function in susceptible patients. Renal function should be assessed when clinically appropriate, and additional monitoring may be required in patients with renal impairment.

Hepatic Impairment

Patients with significant liver disease should receive appropriate medical assessment before and during treatment.

General Instructions

• Take mesalamine according to the prescribed schedule.
• Swallow delayed-release tablets whole with sufficient water unless otherwise directed.
• Do not crush, chew, or break the tablet unless permitted by the approved product information.
• Maintain regular follow-up where monitoring is recommended.
• Do not alter the prescribed dose without professional advice.
• Keep the medicine in its original packaging where appropriate.
• Do not share prescription medicines with other people.
• Follow the approved product information and healthcare professional’s instructions.

Special Dietary / Lifestyle Tips

No specific dietary restriction is generally required unless advised by a healthcare professional.

Patients with inflammatory bowel disease may have individual dietary requirements depending on disease activity, nutritional status, and other clinical factors. Any specific dietary plan should be discussed with a qualified healthcare professional or dietitian.

Comparison with Other Treatments

Mesalamine is an aminosalicylate anti-inflammatory medicine used primarily for inflammatory bowel diseases such as ulcerative colitis. Other treatments for inflammatory bowel disease may include corticosteroids, immunomodulators, biologic medicines, or other targeted therapies.

These treatments differ in mechanism, route of administration, onset of action, safety considerations, monitoring requirements, and clinical indications. Treatment selection depends on disease severity, location, treatment history, response, and individual clinical factors.

Precautions & Warnings

• Confirm any history of hypersensitivity to mesalamine, salicylates, or formulation components.
• Assess kidney function before and during treatment when clinically appropriate.
• Use with caution in patients with existing renal impairment.
• Patients taking potentially nephrotoxic medicines may require additional monitoring.
• Seek medical advice if symptoms suggest kidney impairment, such as significant changes in urine output.
• Monitor for severe abdominal symptoms or an acute intolerance reaction that may resemble worsening inflammatory bowel disease.
• Patients with liver disease may require appropriate clinical monitoring.
• Use during pregnancy or breastfeeding should follow professional assessment.
• Report severe skin reactions, chest pain, breathing difficulty, or other significant symptoms promptly.

Can I Use It With Other Medicines?

Generally Compatible With

Mesalamine can be prescribed with other medicines when clinically appropriate and after consideration of the patient’s complete medication profile. Many patients with inflammatory bowel disease may receive additional medicines depending on their clinical condition.

Use With Caution / Avoid

Professional advice is particularly important when mesalamine is used with:

• NSAIDs
• Other medicines that may affect kidney function
• Azathioprine
• 6-mercaptopurine
• Thioguanine
• Anticoagulants such as warfarin

Do not start, stop, or change other medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What is Mesalamine Delayed Release Tablets USP 400 mg used for?

Mesalamine delayed-release tablets are used in the management of inflammatory bowel disease, particularly ulcerative colitis, when mesalamine treatment is clinically indicated.

2. What is the active ingredient in Mesalamine 400 mg Tablets?

The active ingredient is mesalamine 400 mg per delayed-release tablet.

3. How does Mesalamine work?

Mesalamine acts primarily within the intestinal mucosa to reduce inflammatory activity associated with inflammatory bowel disease. Its action involves modulation of inflammatory pathways and mediators.

4. How should Mesalamine Delayed Release Tablets be taken?

The tablets should be taken exactly as prescribed and generally swallowed whole with sufficient water. Delayed-release tablets should not be crushed or chewed unless specifically permitted by the approved product information.

5. Can Mesalamine affect the kidneys?

Yes. Kidney-related adverse effects can occur in susceptible patients. Renal function may therefore be assessed before and during treatment, particularly in patients with existing kidney problems or relevant risk factors.

6. Can Mesalamine be used during pregnancy?

Mesalamine should be used during pregnancy only after appropriate medical assessment. Patients who are pregnant or planning pregnancy should discuss treatment with a healthcare professional.

7. Can Mesalamine be taken with other medicines?

Mesalamine can be used with other medicines when clinically appropriate, but particular attention may be required with medicines that affect kidney function, NSAIDs, immunomodulators, and anticoagulants.

8. How should Mesalamine 400 mg delayed-release tablets be stored?

Store the product according to the conditions stated on the approved product label and package insert. Keep it in the original packaging where appropriate and out of reach of children.