Asacol 400 mg (Mesalamine) Used to Treat Ulcerative Colitis, Proctitis, Proctosigmoiditis, and Crohn’s Disease
Asacol 400 mg (mesalamine) is a delayed-release tablet used for the treatment and prevention of short episodes of ulcerative colitis (inflammatory disease of colon) and Crohn’s ileocolitis (inflammation of lining of ileum and colon). It works by reducing inflammation in the colon, helping control symptoms like diarrhea, abdominal pain, and rectal bleeding while maintaining long-term remission.
Product Overview
Asacol 400 mg is an anti-inflammatory medication specifically designed to treat and manage ulcerative colitis and inflammatory bowel disease (IBD). Containing Mesalamine (also known as 5-aminosalicylic acid or 5-ASA), it acts locally on the lining of the colon to reduce inflammation, swelling, and tissue damage. Asacol tablets are formulated with a special pH-dependent enteric coating. This coating ensures the medication passes through the stomach and small intestine safely, only dissolving when it reaches the terminal ileum and colon, where the inflammation is typically most severe.
Product Composition
The therapeutic efficacy of Asacol is driven by its active ingredient and its delivery system:
- Mesalamine (400 mg): An aminosalicylate that inhibits the production of substances that cause inflammation in the bowel.
- Eudragit-S Coating: A specialized pH-sensitive resin that prevents the tablet from releasing the drug until it reaches an environment with a pH of 7 or higher (the lower gut).
Product Specification
| Feature | Details |
| Therapeutic Class | Aminosalicylate (5-ASA) |
| Active Ingredient | Mesalamine |
| Dosage Form | Delayed-Release Tablet |
| Strength | 400 mg |
| Primary Indication | Ulcerative Colitis |
Mechanism of Action
Asacol works through a local topical effect on the intestinal mucosa rather than through systemic absorption into the bloodstream:
- Leukotriene Inhibition: It blocks the activity of cyclooxygenase and lipoxygenase, reducing the production of prostaglandins and leukotrienes—chemicals that trigger pain and inflammation in the gut.
- Antioxidant Action: It acts as a scavenger for free radicals (reactive oxygen molecules) that are known to damage the intestinal tissue during active flare-ups.
- Immune Modulation: It helps normalize the immune response within the intestinal wall, preventing the white blood cells from over-reacting to triggers.
- pH-Targeted Delivery: The enteric coating ensures that the 400 mg of Mesalamine is delivered precisely to the colon, maximizing local treatment while minimizing side effects in the upper digestive tract.
Key Benefits
- Effective Remission Induction: Helps bring active ulcerative colitis symptoms (such as bleeding and diarrhea) under control during a flare-up.
- Maintenance of Remission: When taken long-term, it significantly reduces the risk of future flare-ups, allowing patients to lead a normal, symptom-free life.
- Targeted Action: Because the drug acts locally in the gut, very little enters the bloodstream, which generally results in fewer side effects compared to systemic steroids.
- Steroid-Sparing: Successful treatment with Asacol can often reduce or eliminate the need for long-term corticosteroid use.
- Proven Safety Profile: Mesalamine is a well-established first-line treatment for mild-to-moderate ulcerative colitis with decades of clinical use.
Precautions
Asacol 400 mg (Mesalamine) should be used carefully under medical supervision to ensure safe and effective treatment of ulcerative colitis and inflammatory bowel disease.
Medical Conditions to Inform Your Doctor
| Condition | Why It Matters |
|---|---|
| Kidney disease | Mesalamine may affect kidney function and requires monitoring |
| Liver disease | May need dose adjustment and regular liver function tests |
| History of salicylate allergy | Risk of hypersensitivity reaction |
| Heart disease | Rare risk of worsening symptoms in sensitive patients |
| Stomach or bowel obstruction | Requires careful evaluation before use |
Use and Monitoring Precautions
- Take exactly as prescribed by your doctor
- Do not crush or chew delayed-release tablets
- Regular kidney function tests are recommended during long-term use
- Maintain adequate hydration during treatment
Gastrointestinal Effects
- May cause mild stomach upset in some patients
- Report worsening abdominal pain, bleeding, or persistent diarrhea
- Do not stop medication suddenly without medical advice
Pregnancy and Breastfeeding
- Generally considered safe under medical supervision
- Use only if clearly prescribed by a doctor
General Advice
- Inform your doctor about all medicines you are taking
- Avoid self-medication or dose changes
- Store in a cool, dry place away from moisture and heat
- Seek medical attention if allergic reactions or severe symptoms occur
Usage
Asacol must be taken regularly to maintain a constant level of Mesalamine in the colon. It is essential to follow the specific instructions regarding the integrity of the tablet to ensure the drug reaches the intended site of action.
Dosage & Administration
The dosage varies depending on whether you are treating an active flare-up (induction) or preventing a new one (maintenance).
| Aspect | Recommendation |
| Tablet Integrity | Must be swallowed whole. Never crush, chew, or break. |
| Hydration | Drink plenty of fluids to maintain good kidney function. |
| Timing | Usually taken 3 times daily, but follow your doctor's specific schedule. |
| Food | Can be taken with or without food. |
Important Guidelines
Consistency: For maintenance therapy, it is crucial to take your doses at the same time every day to prevent a relapse.
Kidney Monitoring: Your healthcare provider will likely schedule periodic blood tests (Creatinine) to ensure your kidneys are processing the medication safely.
Storage: Keep the tablets in their original moisture-resistant container, as the coating can be sensitive to humidity.
Aspirin Sensitivity: If you have an allergy to Aspirin or other salicylates, inform your doctor, as Asacol belongs to the same chemical family.
Uses
Asacol is primarily utilized as a first-line treatment for managing chronic inflammatory conditions of the lower gastrointestinal tract.
Treatment of Active Ulcerative Colitis: Used to reduce inflammation during mild-to-moderate flare-ups, helping to stop rectal bleeding and normalize bowel movements.
Maintenance of Remission: Once symptoms are under control, it is used long-term to keep the disease inactive and prevent the recurrence of symptoms.
Proctosigmoiditis Management: Effective for inflammation limited to the rectum and the lower part of the colon.
Off-Label Use for Crohn’s Disease: While primarily for Ulcerative Colitis, some physicians prescribe it for mild cases of Crohn’s disease affecting the ileum or colon.
Post-Surgical Maintenance: Sometimes used after bowel surgery to help prevent the re-emergence of inflammatory symptoms in the remaining sections of the gut.
FAQs
Q: What is Asacol used for?
A: Asacol is used to treat and manage ulcerative colitis. It helps reduce symptoms like rectal bleeding, stomach pain, and diarrhea by lowering inflammation in the colon.
Q: How should I swallow the tablet?
A: You must swallow the tablet whole. Do not crush, chew, or break it. The special coating is designed to protect the medicine until it reaches your colon.
Q: Can I take Asacol with or without food?
A: It can be taken with or without food. However, it is important to be consistent with how you take it each day.
Q: What should I do if I see a whole tablet in my stool?
A: If you occasionally notice an empty tablet shell or a whole tablet in your stool, contact your doctor. It may mean the medicine is not being absorbed properly.
Q: How long do I need to take this medication?
A: Asacol is often used for long-term "maintenance" therapy. Even if you feel better, you should keep taking it to prevent symptoms from returning.
Q: Are there any risks to my kidneys?
A: In some cases, mesalamine can affect kidney function. Your doctor will likely perform regular blood tests to monitor your kidney health while you are on this treatment.
Q: What if I miss a dose?
A: Take it as soon as you remember. If it is almost time for your next dose, skip the missed one. Do not take two doses at the same time.
Q: Can I take Asacol if I am allergic to Aspirin?
A: No. If you have a known allergy to aspirin or other salicylates, you should not take Asacol. Inform your doctor about any allergies before starting.
| Manufacturer | : | A. Menarini India Pvt Ltdine HCL) |
| Trade Name | : | Asacol |
| Generic Search | : | Mesalamine |
| Strength | : | 400mg |




















