Mesalamine Prolonged Release Tablets Usp 1.2 Gm Tablet

What is Mesalamine Prolonged Release Tablets Usp 1.2 Gm Tablet?

Mesalamine Prolonged Release Tablets USP 1.2 Gm contain mesalamine, also known as 5-aminosalicylic acid (5-ASA), an aminosalicylate anti-inflammatory medicine. The prolonged-release tablet is designed to deliver mesalamine within the gastrointestinal tract and is used in the management of inflammatory bowel conditions, particularly ulcerative colitis, according to approved product information.

Uses / Indications

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

• Ulcerative colitis
• Active inflammatory bowel disease involving the colon, where mesalamine therapy is indicated
• Maintenance of remission in ulcerative colitis, depending on the approved product indication

The specific indication, treatment duration and regimen should follow the approved product information and healthcare professional guidance.

Benefits

• Provides mesalamine for local anti-inflammatory activity in the gastrointestinal tract.
• Prolonged-release formulation is designed to deliver the active ingredient over an extended period.
• Used as part of medical management for ulcerative colitis.
• May be used for maintaining remission when clinically appropriate.
• Provides a 1.2 g oral tablet strength for prescribed treatment regimens.

Side Effects

Common Side Effects

Possible adverse effects may include:

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

Less Common or Serious Side Effects

Clinically important reactions may include:

• Hypersensitivity or allergic reactions
• Pancreatitis
• Hepatitis or other liver-related abnormalities
• Changes in kidney function, including interstitial nephritis
• Blood disorders such as reduced blood cell counts
• Severe skin reactions
• Worsening of colitis symptoms in rare cases

Patients developing severe abdominal pain, significant changes in urine output, unusual bleeding or bruising, severe rash, breathing difficulty, or other serious symptoms should seek medical attention.

How Does It Work?

Mesalamine

Mesalamine is an aminosalicylate anti-inflammatory agent. It acts primarily within the intestinal tract and is associated with inhibition of inflammatory pathways and mediators involved in intestinal inflammation.

The prolonged-release formulation is designed to release mesalamine over an extended period, supporting its therapeutic action at the intended gastrointestinal sites.

Dosage Guidelines

The appropriate dosage and treatment duration depend on factors such as:

• Disease activity and extent
• Treatment indication
• Response to therapy
• Age
• Kidney function
• Other medical conditions
• Concomitant medicines

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

For oral tablets:

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

When Not to Use

Mesalamine should generally not be used in patients with:

• Known hypersensitivity to mesalamine, other aminosalicylates, or any component of the formulation
• Certain serious renal disorders, where use is contraindicated according to the approved product information

Medical advice is particularly important in patients with a history of kidney or liver disease, blood disorders, or previous intolerance to salicylates.

Drug / Product Interactions

Clinically relevant interactions may occur depending on the patient’s medication profile. Particular attention may be required when mesalamine is used with:

• Anticoagulants
• Thiopurines such as azathioprine or 6-mercaptopurine
• Other medicines that may affect kidney function
• Medicines with potential gastrointestinal or blood-related adverse effects

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

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 pass into 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 in the approved product information and healthcare professional guidance.

Elderly Patients

Older patients may require appropriate monitoring, particularly where kidney function or multiple concomitant medicines are concerns.

Renal Impairment

Mesalamine can affect kidney function in susceptible patients. Appropriate assessment and monitoring of renal function may be required, particularly in patients with pre-existing renal impairment.

Hepatic Impairment

Patients with liver disease should inform their healthcare professional before treatment. Appropriate clinical monitoring may be considered according to the patient’s condition.

General Instructions

• Take the medicine according to the prescribed schedule.
• Swallow prolonged-release tablets with sufficient water unless otherwise directed.
• Do not crush or chew the tablet unless specifically permitted by the approved product information.
• Do not alter the dosage without professional advice.
• Keep the medicine in its original packaging where appropriate.
• Follow the approved product information and healthcare professional’s instructions.
• Do not share prescription medicines with other people.

Special Dietary / Lifestyle Tips

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

Patients with inflammatory bowel disease may receive individual dietary guidance based on disease activity, nutritional status and clinical requirements.

Comparison with Other Treatments

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

Treatment selection depends on factors such as disease location, severity, treatment objective, previous response, tolerability and the approved indication. Mesalamine may be used alone or as part of a broader treatment strategy depending on the clinical situation.

Precautions & Warnings

• Confirm any history of hypersensitivity to mesalamine, salicylates or related medicines.
• Kidney function may require assessment before and during treatment where clinically appropriate.
• Use with caution in patients with existing renal or hepatic impairment.
• Inform the healthcare professional about previous blood disorders or significant medicine reactions.
• Monitor for unusual bleeding, bruising or other symptoms suggestive of blood abnormalities.
• Seek medical attention if severe abdominal symptoms, allergic reactions, severe skin reactions or significant changes in urine output occur.
• Patients taking medicines that may affect kidney function should inform their healthcare professional.
• Use during pregnancy or breastfeeding should be based on appropriate professional assessment.

Can I Use It With Other Medicines?

Generally Compatible With

Mesalamine can be prescribed alongside other medicines when clinically appropriate. Compatibility depends on the patient’s complete medication profile and medical condition.

Use With Caution / Avoid

Professional advice is particularly important when mesalamine is used with:

• Anticoagulant medicines
• Thiopurine medicines such as azathioprine or 6-mercaptopurine
• Medicines that may affect kidney function
• Other medicines with potentially significant gastrointestinal, renal or blood-related effects

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 Prolonged Release Tablets USP 1.2 Gm used for?

Mesalamine prolonged-release tablets are used in the management of inflammatory bowel conditions, particularly ulcerative colitis, when mesalamine therapy is clinically indicated.

2. What is the active ingredient in Mesalamine 1.2 g Tablets?

The active ingredient is mesalamine 1.2 g per tablet.

3. How does Mesalamine work?

Mesalamine is an aminosalicylate anti-inflammatory agent that acts primarily within the intestinal tract to reduce inflammatory activity.

4. What does prolonged release mean?

A prolonged-release formulation is designed to release the active ingredient over an extended period rather than providing immediate release of the entire dose.

5. How should Mesalamine 1.2 g tablets be taken?

The tablets should be taken exactly as prescribed. Prolonged-release tablets should generally be swallowed whole with sufficient water unless the approved product information states otherwise.

6. Can Mesalamine be used in patients with kidney problems?

Patients with renal impairment require appropriate medical assessment because mesalamine may affect kidney function. Monitoring and treatment adjustments may be considered by a healthcare professional.

7. Can Mesalamine be taken with other medicines?

Mesalamine may be used with other medicines when clinically appropriate, but potential interactions should be assessed, particularly with anticoagulants, thiopurines and medicines that may affect renal function.

8. How should Mesalamine 1.2 g tablets be stored?

Store the product according to the conditions stated on the approved product label and package insert, and keep it out of reach of children.