Mesacol 400mg (15 Tabs)

MESACOL 400MG (15 TABS) by SUN PHARMA-SYGNUS DIV

Mesacol 400mg Tablets are an anti-inflammatory medication primarily used to manage inflammatory bowel diseases. Manufactured by Sun Pharmaceutical Industries Ltd., it is an essential medicine for patients suffering from chronic intestinal conditions.

• Name

  • Brand Name: Mesacol 400mg Tablets
  • Common Name/Active Ingredient: Mesalazine (also known as Mesalamine or 5-aminosalicylic acid)

• Composition

  • Each tablet contains 400mg of Mesalazine (5-aminosalicylic acid).

• Uses Mesacol 400mg is prescribed for the treatment and maintenance of remission of:

  • Mild to moderately active Ulcerative Colitis (a chronic inflammatory bowel disease causing inflammation and ulcers in the large intestine).
  • Crohn's Disease (another form of inflammatory bowel disease). It helps alleviate associated symptoms such as diarrhea, rectal bleeding, and abdominal pain by reducing inflammation in the intestines.

• Dosage and Administration

  • Adults (Active Ulcerative Colitis): Individual dosage, typically up to 4 grams of mesalazine once daily or divided into 2-4 doses. For maintenance treatment, the recommended dosage is 2 grams of mesalazine once daily.
  • Children (6 years and older): Dosage is determined individually by a doctor. For active disease, it may start from 30-50 mg/kg/day in divided doses, with a maximum of 75 mg/kg/day, not exceeding the maximum adult dose of 4 g/day. For maintenance, it's 15-30 mg/kg/day in divided doses, not exceeding the adult recommended dose of 2 g/day. Children up to 40 kg may receive half the adult dose, while those over 40 kg may receive the normal adult dose.
  • Mesacol 400mg Tablets should be swallowed whole with a glass of water; they should not be crushed, chewed, or broken.
  • It is generally recommended to take the tablets with food to reduce gastrointestinal discomfort and enhance absorption. Some sources also state it can be taken one hour before or two hours after food.
  • Take the medicine at the same time each day for optimal results and do not discontinue treatment without consulting your doctor.

• Side Effects Common side effects may include:

  • Headache
  • Nausea and Vomiting
  • Abdominal pain or Indigestion (dyspepsia)
  • Diarrhea
  • Dizziness
  • Rash or itching (pruritus)
  • Fatigue or Asthenia
  • Flatulence Less common or serious side effects can include blurred vision, hair loss, constipation, dry mouth, increased sweating, severe skin reactions (like Stevens-Johnson syndrome or toxic epidermal necrolysis), or signs of acute intolerance syndrome (cramping, severe stomach pain, bloody stools, fever, headache, rash). Consult your doctor if any side effects persist or worsen, or if severe reactions occur.

• Precautions

  • Allergies: Do not use if allergic to Mesalazine, salicylates (e.g., aspirin), or sulfasalazine.
  • Kidney/Liver Impairment: Not recommended for patients with severe kidney or liver disease. Use with caution in mild to moderate impairment. Renal function should be evaluated prior to and monitored periodically during treatment.
  • Elderly Patients: Use with caution in patients 65 years or older due to increased risk of kidney and liver impairment.
  • Drug Interactions: Concurrent use of other nephrotoxic agents (e.g., NSAIDs, azathioprine) may increase the risk of renal reactions.
  • Pregnancy and Lactation: Mesacol is Pregnancy Category B. Use with caution in pregnant and breastfeeding women only if clearly necessary, and after consulting a doctor.
  • Other Conditions: Exercise caution in patients with pyloric stenosis or other obstructive conditions of the stomach/gut, lung problems, or a history of heart problems.
  • Children: Safety and efficacy have not been established for children under 6 years of age.
  • Monitoring: Regular monitoring of blood cell counts is advised during therapy.

• Storage

  • Store below 30°C (some sources specify below 25°C).
  • Protect from light and moisture.
  • Keep all medicines out of the reach of children.
  • Store in a cool and dry place.

MESACOL 400MG (15 TABS) is a medication primarily used for its anti-inflammatory properties in the gastrointestinal tract. It contains Mesalazine (also known as mesalamine or 5-Aminosalicylic Acid) as its active ingredient.

Here are some frequently asked questions about MESACOL 400MG:

What is Mesacol 400mg used for?

Mesacol 400mg is primarily used to treat and manage inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease. It helps to alleviate symptoms like inflammation, abdominal pain, diarrhea, and rectal bleeding. It can also help prevent the recurrence of these symptoms.

How does Mesacol 400mg work?

Mesacol 400mg contains Mesalazine, which is an anti-inflammatory drug. It works by inhibiting the production of certain chemical substances in the intestines, such as prostaglandins, that cause pain and swelling. By suppressing these chemical messengers, it reduces inflammation and ulceration in the intestines, providing relief from symptoms.

What is the usual dosage of Mesacol 400mg?

The dosage of Mesacol 400mg can vary based on the condition and individual response. For adults with active ulcerative colitis, the dosage can be up to 4 grams of mesalazine once daily or divided into 2-4 doses. A common recommendation for active disease is 800mg (two 400mg tablets) three times daily for about 6 weeks. For maintenance treatment, a recommended dosage is often 2 grams of mesalazine once daily. For children aged 6 years and older, the dosage is determined individually based on body weight, starting with 30-50 mg/kg/day in divided doses, not exceeding 4 g/day. Always follow your doctor's prescribed dosage and duration.

What are the possible side effects of Mesacol 400mg?

Common side effects of Mesacol 400mg include headache, nausea, abdominal pain, diarrhea, vomiting, and flatulence (gas). Other reported side effects may include indigestion, itching, rash, and dizziness. Most of these side effects are usually temporary and resolve over time. However, if any side effects persist or worsen, you should consult your doctor. In rare cases, severe skin reactions or blood abnormalities may occur, and medical attention should be sought immediately if such symptoms arise.

Is Mesacol 400mg safe during pregnancy or breastfeeding?

Mesacol 400mg should be used with caution during pregnancy and breastfeeding, and only if clearly necessary, after consulting your doctor. There is limited information on its safety during pregnancy, and animal studies have shown potential harmful effects on the developing baby. It may also pass into breast milk, and caution is advised for nursing mothers. Your doctor will weigh the benefits against potential risks before prescribing it.

Can Mesacol 400mg be taken with other medications?

It is important to inform your doctor about all other medications, herbal preparations, and supplements you are taking to avoid potential interactions. Caution is advised when taking Mesacol 400mg with:

• NSAIDs (non-steroidal anti-inflammatory drugs) like aspirin, ibuprofen, diclofenac, as they may increase the risk of renal reactions.
• Azathioprine, mercaptopurine, or thioguanine (used for autoimmune diseases or cancer) as concurrent use may require caution.
• Warfarin (a blood thinner), as Mesacol may decrease its effect.
• Sulfasalazine or other salicylates, especially if you have had blood abnormalities or kidney problems with them.
• Lactulose or other drugs that lower pH, as they may prevent the release of mesalazine.
• Cidofovir as there is a critical interaction.

What precautions should be taken while taking Mesacol 400mg?

Before starting Mesacol 400mg, inform your doctor if you have any existing medical conditions, especially kidney or liver problems, or a history of allergic reactions to mesalazine or salicylates. Mesacol is not recommended for patients with severe kidney failure. Regular monitoring of kidney function is advised during treatment. Use with caution in elderly patients. If you experience severe skin reactions (like Stevens-Johnson syndrome), severe stomach pain, cramps, severe headache, fever, or rash, stop taking the medication immediately and consult your doctor. Mesacol 400mg is not recommended for children below 6 years of age, and safety and efficacy in children under 18 may not be fully established.

What happens if a dose of Mesacol 400mg is missed?

If you miss a dose of Mesacol 400mg, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you frequently miss doses, consider setting an alarm or asking a family member to remind you.

How should Mesacol 400mg be stored?

Mesacol 400mg tablets should be stored in a cool and dry place, protected from direct sunlight, moisture, and heat. The storage temperature should generally be below 25°C or 30°C. Keep all medicines out of the reach and sight of children.