GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Mesalamine Prolonged Release Tablets IP 1200mg
B. Mesalamine Delayed Release Tablets IP 800mg
C. Mesalamine Delayed Release Tablets IP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mesalamine Prolonged Release Tablets IP 1200mg
Each film-coated Prolonged release tablet contains:
Mesalamine IP …………………1200mg
Excipients…………………………q.s.
Colour: Iron Oxide Red

B. Mesalamine Delayed Release Tablets IP 800mg
Each film-coated delayed release tablet contains:
Mesalamine IP …………………800mg
Excipients…………………………q.s.
Colour: Ferric Oxide Red


C. Mesalamine Delayed Release Tablets IP 400mg
Each film-coated delayed release tablet contains:
Mesalamine IP …………………400mg
Excipients…………………………q.s.
Colour: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease. They are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Asacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

CAUTION & SCHEDULE:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Specialist/Gastroenterologist.

STORAGE & DOSAGE:

STORAGE: Store in between 20°C to 25°C.
Excursion are permitted 15°C to 30°C.
Keep in cool & Dry place.
Protect from Light.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.

Mesalamine Delayed Release Tablets IP 800mg Technical Specification:

Product Name:Mesalamine Delayed Release Tablets IP 800mg
Brand Name:Meslataj-DR
Strength:1200mg, 800mg, 400mg
Dosage Form:Delayed Release Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:10s, 15s, 50s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Treatment of ulcerative colitis
Indication: Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). They are indicated for the maintenance of remission of ulcerative colitis in adults.
Storage:Store in between 20°C to 25°C. Excursion are permitted 15°C to 30°C. Keep in cool & Dry place. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mesalamine Delayed Release Tablets IP 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mesalamine Delayed Release Tablets IP 800mg
    Each film-coated delayed release tablet contains:
    Mesalamine IP …………………800mg
    Excipients…………………………q.s.
    Colour: Ferric Oxide Red

THERAPEUTIC INDICATIONS:

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease. They are indicated for the maintenance of remission of ulcerative colitis in adults. The safety and effectiveness of Asacol for the maintenance of remission of ulcerative colitis in pediatric patients have not been established.

CAUTION & SCHEDULE:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Specialist/Gastroenterologist.

STORAGE & DOSAGE:

STORAGE: Store in between 20°C to 25°C. Excursion are permitted 15°C to 30°C. Keep in cool & Dry place.  Protect from Light.
Keep medicine out of reach of children.
Read enclosed leaflet before use.
Dosage: As Directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a highly regarded pharmaceutical company known for its Mesalamine Tablets. They have earned a strong reputation for their unwavering commitment to producing top-quality medications that adhere to international standards. Taj Pharmaceuticals boasts a wealth of experience and expertise in pharmaceutical manufacturing, backed by a team of seasoned professionals dedicated to enhancing patient health. Their robust research and development initiatives ensure the continuous improvement of Mesalamine Tablets, with a focus on innovation and patient-friendly formulations. With a global presence, Taj Pharmaceuticals ensures that patients worldwide have access to their medications through a reliable distribution network. They prioritize compliance with stringent regulatory guidelines and maintain manufacturing facilities that meet the highest quality standards. Taj Pharmaceuticals’ patient-centric approach emphasizes affordability without compromising the effectiveness of medications like Mesalamine Tablets. Additionally, their exceptional customer support services and ethical business practices further enhance their credibility among healthcare providers and patients alike. In summary, Taj Pharmaceuticals’ unwavering commitment to quality, research, patient well-being, and global accessibility positions them as a reputable choice for Mesalamine Tablets and various other pharmaceutical products, instilling confidence in the safety and efficacy of their medications.

What is Mesalamine Tablets and its uses:

Mesalamine Tablets are a medication primarily used to treat various inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease. Mesalamine is the active ingredient in these tablets, and it belongs to a class of drugs known as amino salicylates. Here are the key uses of Mesalamine Tablets:

  • Ulcerative Colitis: Mesalamine Tablets are commonly prescribed to individuals with ulcerative colitis, a chronic inflammatory condition that primarily affects the colon (large intestine). They help reduce the inflammation associated with this condition, alleviate symptoms such as abdominal pain, diarrhea, and rectal bleeding, and promote remission.
  • Crohn’s Disease: Mesalamine Tablets can also be used to manage mild to moderate forms of Crohn’s disease, another type of IBD that can affect any part of the digestive tract. While they are more commonly associated with ulcerative colitis treatment, Mesalamine Tablets may help control inflammation and provide relief for some individuals with Crohn’s disease.
  • Maintenance Therapy: In addition to treating active flare-ups of ulcerative colitis or Crohn’s disease, Mesalamine Tablets are often prescribed as maintenance therapy. This means that they are used on an ongoing basis to prevent or reduce the frequency and severity of disease relapses or flares.
  • Proctitis and Proctosigmoiditis: Mesalamine Tablets can be beneficial for individuals with limited forms of ulcerative colitis, such as proctitis (inflammation of the rectum) and proctosigmoiditis (inflammation of the rectum and sigmoid colon).
  • Other Gastrointestinal Conditions: In some cases, healthcare providers may use Mesalamine Tablets to manage other gastrointestinal conditions characterized by inflammation, but their primary indication remains the treatment of IBD.

It’s important to note that the specific dosing and duration of Mesalamine Tablets will vary depending on the individual’s condition and its severity. Treatment plans are typically tailored to the patient’s needs and may involve various formulations of Mesalamine, including oral tablets, capsules, suppositories, enemas, or rectal foams. Patients should always follow their healthcare provider’s instructions and attend regular follow-up appointments while using Mesalamine Tablets to monitor their progress and manage potential side effects.

How do Mesalamine Tablets work?

Mesalamine Tablets work by reducing inflammation in the gastrointestinal tract, particularly in individuals with inflammatory bowel diseases (IBD) like ulcerative colitis and Crohn’s disease. The exact mechanism of action of Mesalamine is not fully understood, but it is thought to involve several key processes:

  • Anti-Inflammatory Properties: Mesalamine is classified as an amino salicylate, a type of medication with anti-inflammatory properties. It acts locally within the digestive tract to suppress inflammation, which is a hallmark feature of IBD. Inflammation in the gastrointestinal lining can lead to the symptoms and damage associated with these conditions.
  • Immune Modulation: Mesalamine may help regulate the immune response in the gut. In IBD, the immune system mistakenly attacks healthy tissues in the digestive tract, leading to chronic inflammation. Mesalamine is believed to modulate this immune response, reducing the inflammation and its associated symptoms.
  • Mucosal Barrier Protection: The medication may enhance the protective mucosal barrier lining the inner surface of the gastrointestinal tract. In IBD, this barrier can become compromised, allowing harmful substances to penetrate the tissue and trigger inflammation. Mesalamine is thought to strengthen this barrier, helping to prevent further damage.
  • Interference with Inflammatory Mediators: Mesalamine may interfere with the production and activity of various inflammatory mediators, such as cytokines and prostaglandins, which play a role in the inflammatory process. By reducing the levels of these mediators, Mesalamine helps mitigate inflammation.
  • Local Action: Importantly, Mesalamine acts primarily locally within the gastrointestinal tract. It is designed to release the active drug directly where it is needed, minimizing systemic absorption and potential side effects.

It’s important to note that the exact mode of action of Mesalamine may vary depending on the formulation (e.g., oral tablets, suppositories, enemas) and the specific area of the gastrointestinal tract being treated. Mesalamine is often prescribed in various forms to target different parts of the digestive tract, as the location and extent of inflammation can vary among individuals with IBD. Treatment plans are tailored to each patient’s unique condition and needs, and they should be discussed with a healthcare provider.

Benefits and Side Effects of Mesalamine Tablets:

Mesalamine Tablets offer several benefits for individuals with inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease. However, like any medication, they may also have associated side effects. Here’s an overview of the benefits and potential side effects of Mesalamine Tablets:

Benefits:

  • Anti-Inflammatory Effect: Mesalamine is highly effective in reducing inflammation in the gastrointestinal tract. This anti-inflammatory action helps alleviate the symptoms of IBD, such as abdominal pain, diarrhea, and rectal bleeding.
  • Maintenance Therapy: Mesalamine Tablets are often used as maintenance therapy to keep IBD in remission and prevent disease flares. They can help prolong periods of symptom-free living.
  • Localized Treatment: Mesalamine works locally within the digestive tract, minimizing systemic absorption. This localized action helps reduce the risk of systemic side effects often associated with other medications used to treat IBD.
  • Variety of Formulations: Mesalamine is available in various formulations, including oral tablets, capsules, suppositories, enemas, and rectal foams. This allows healthcare providers to tailor treatment to the location and extent of inflammation within the gastrointestinal tract.
  • Potential Reduction in Complications: By managing inflammation, Mesalamine may reduce the risk of complications associated with IBD, such as strictures and fistulas.

Side Effects:

  • Gastrointestinal Symptoms: Common side effects of Mesalamine Tablets include nausea, diarrhea, abdominal pain, and flatulence. These symptoms are usually mild and temporary.
  • Headache: Some individuals may experience headaches while taking Mesalamine.
  • Allergic Reactions: Although rare, allergic reactions to Mesalamine can occur. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if any of these symptoms occur.
  • Kidney and Liver Function: Mesalamine can affect kidney and liver function in some people. Regular monitoring of kidney and liver function is typically recommended during treatment.
  • Blood Disorders: Rarely, Mesalamine may affect blood cell counts. It’s important to report any signs of unusual bleeding, bruising, or persistent sore throat to a healthcare provider.
  • Pancreatitis: In very rare cases, Mesalamine may cause pancreatitis, which can lead to abdominal pain, nausea, and vomiting.
  • Lung Issues: Mesalamine has been associated with lung problems in rare instances. If you experience new or worsening respiratory symptoms, such as cough or shortness of breath, inform your healthcare provider.

It’s essential for individuals taking Mesalamine Tablets to have regular check-ups with their healthcare provider to monitor for side effects and assess the medication’s effectiveness. Additionally, patients should follow their healthcare provider’s guidance regarding dosing and treatment duration. Mesalamine is generally considered safe and well-tolerated when used as prescribed, and its benefits in managing IBD often outweigh the potential risks of side effects.

Frequently Asked Questions About Mesalamine Tablets:

Certainly, here are some frequently asked questions (FAQs) about Mesalamine Tablets:

  1. What is Mesalamine, and what conditions does it treat?

Mesalamine is a medication used to treat inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease. It helps reduce inflammation in the gastrointestinal tract and alleviate symptoms associated with these conditions.

  1. How does Mesalamine work?

Mesalamine works by reducing inflammation in the digestive tract, particularly in the colon and rectum. It has anti-inflammatory properties and helps regulate the immune response in the gut.

  1. Are there different forms of Mesalamine available?

Yes, Mesalamine is available in various formulations, including oral tablets, capsules, suppositories, enemas, and rectal foams. The choice of formulation depends on the location and extent of inflammation within the gastrointestinal tract.

  1. What are the common side effects of Mesalamine Tablets?

Common side effects of Mesalamine Tablets may include nausea, diarrhea, abdominal pain, headache, and flatulence. These side effects are usually mild and temporary.

  1. Are there any serious side effects associated with Mesalamine?

While rare, Mesalamine can have serious side effects, including allergic reactions, kidney or liver problems, blood disorders, and pancreatitis. It’s important to report any unusual symptoms to a healthcare provider promptly.

  1. Can Mesalamine Tablets be used for maintenance therapy in IBD?

Yes, Mesalamine Tablets are often prescribed as maintenance therapy to keep IBD in remission and prevent disease flares. They can help extend periods of symptom free living.

  1. How long does it take for Mesalamine Tablets to start working?

The onset of relief can vary from person to person. Some individuals may experience improvement in symptoms within a few weeks, while others may take longer. It’s essential to continue taking the medication as prescribed.

  1. Can Mesalamine be taken with other medications for IBD?

Yes, Mesalamine can be used in combination with other medications, such as immunosuppressants or biologics, depending on the severity and type of IBD. Your healthcare provider will determine the most suitable treatment plan.

  1. Are there any dietary restrictions while taking Mesalamine Tablets?

There are typically no specific dietary restrictions while taking Mesalamine. However, it’s advisable to follow a well-balanced diet and stay hydrated to support your overall health.

  1. Is it safe to take Mesalamine during pregnancy or while breastfeeding?

Pregnant or breastfeeding individuals should discuss the risks and benefits of Mesalamine with their healthcare provider. In some cases, the medication may be prescribed if the potential benefits outweigh the risks.

It’s important to remember that these FAQs provide general information, and individual experiences with Mesalamine may vary. Always follow your healthcare provider’s recommendations and seek their guidance for any specific concerns or questions regarding your treatment with Mesalamine Tablets.

As Mesalamine Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Mesalamine Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Mesalamine Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Mesalamine Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274