Asacol: Targeted Relief for Ulcerative Colitis Symptoms
| Product dosage: 400mg | |||
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Synonyms
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Asacol (mesalamine) is a prescription medication specifically formulated for the treatment of mild to moderate ulcerative colitis. It belongs to the class of drugs known as 5-aminosalicylates (5-ASAs), which work locally in the colon to reduce inflammation. By directly targeting the site of disease activity, Asacol helps manage symptoms such as diarrhea, rectal bleeding, and abdominal pain. It is available in delayed-release formulations designed to ensure delivery of the active ingredient to the affected areas of the lower gastrointestinal tract. Clinical use is supported by extensive research demonstrating efficacy in inducing and maintaining remission.
Features
- Active ingredient: Mesalamine (also known as mesalazine)
- Formulation: Delayed-release tablets designed for targeted colonic release
- Available strengths: 400 mg and 800 mg delayed-release tablets
- pH-dependent coating that dissolves at pH 7 or higher, typically in the terminal ileum and colon
- Designed to minimize systemic absorption and maximize local anti-inflammatory effects
- Manufactured under strict quality control standards to ensure consistent dosing
Benefits
- Reduces inflammation directly in the colon where ulcerative colitis manifests
- Helps achieve clinical remission by decreasing frequency of bowel movements and rectal bleeding
- Maintains disease remission, potentially reducing frequency of flare-ups
- Minimizes systemic side effects through targeted delivery mechanism
- Supports mucosal healing, an important treatment goal in ulcerative colitis management
- Provides a well-tolerated first-line treatment option with extensive clinical experience
Common use
Asacol is primarily indicated for the treatment of mildly to moderately active ulcerative colitis in adults. It is used both for induction of remission (reducing active symptoms) and maintenance of remission (preventing relapse). Clinical studies have demonstrated its effectiveness in improving sigmoidoscopy scores and reducing disease activity indices. It may be used as monotherapy or in combination with other treatments depending on disease severity and patient response. The medication is particularly valuable for left-sided colitis and proctosigmoiditis where topical action is especially beneficial.
Dosage and direction
For induction of remission in active ulcerative colitis: The typical dosage is 2.4-4.8 grams per day administered in divided doses. Many clinicians start with 2.4 g/day (two 400 mg tablets three times daily or three 800 mg tablets twice daily) and may increase based on response and tolerance.
For maintenance of remission: The recommended dosage is 1.6-2.4 grams per day in divided doses (typically two 400 mg tablets twice daily or one 800 mg tablet three times daily).
Tablets should be swallowed whole with adequate water, without crushing or chewing. Administration with food may help minimize potential gastrointestinal discomfort. Dosage adjustments may be necessary based on individual patient response, tolerability, and disease severity. Treatment duration varies from several weeks for induction to long-term maintenance therapy.
Precautions
Renal function should be assessed before initiating therapy and periodically during treatment, as mesalamine has been associated with renal impairment in some cases. Patients with pre-existing renal disease require careful monitoring. Hepatic function should also be monitored in patients with pre-existing liver conditions. Use with caution in patients with sulfasalazine sensitivity, though cross-reactivity is uncommon. Pulmonary function should be monitored in patients with pre-existing lung disease, particularly asthma. Elderly patients may require dose adjustments due to potential age-related decreases in renal function. Patients should be advised that discoloration of the tablet coating in stool is normal and not indicative of improper absorption.
Contraindications
Asacol is contraindicated in patients with known hypersensitivity to mesalamine, salicylates, or any component of the formulation. It should not be used in patients with severe renal impairment (GFR <30 mL/min). The medication is contraindicated in patients with active peptic ulcer disease. Use is not recommended in patients with history of mesalamine-induced acute intolerance syndrome, which may present with cramping, acute abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash.
Possible side effects
Most common side effects (generally mild and often transient):
- Headache (approximately 6-8% of patients)
- Abdominal pain/cramping (5-7%)
- Nausea (4-6%)
- Diarrhea (3-5%)
- Flatulence (3-4%)
- Rash (2-3%)
Less common but potentially serious side effects requiring medical attention:
- Renal impairment (monitor for decreased urine output, edema, fatigue)
- Acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea, fever)
- Pancreatitis (severe abdominal pain radiating to back, nausea, vomiting)
- Hepatic abnormalities (jaundice, dark urine, light-colored stools)
- Pulmonary toxicity (cough, shortness of breath, wheezing)
- Blood dyscrasias (unusual bleeding/bruising, fatigue, fever)
Drug interaction
Mesalamine may potentiate the effects of anticoagulants like warfarin, requiring more frequent INR monitoring. Concurrent use with other nephrotoxic drugs (NSAIDs, aminoglycosides, cyclosporine) may increase renal toxicity risk. Azathioprine or 6-mercaptoprine co-administration may potentially increase risk of blood disorders. Proton pump inhibitors and other medications that significantly alter gastric pH may theoretically affect the delayed-release mechanism, though clinical significance remains uncertain. Live bacterial vaccines may have reduced efficacy during mesalamine therapy.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one. Maintaining consistent dosing is important for therapeutic effect, but occasional missed doses are unlikely to significantly impact overall treatment efficacy, particularly in maintenance therapy.
Overdose
Mesalamine overdose may present with symptoms including severe nausea, vomiting, diarrhea, abdominal pain, dizziness, and tinnitus. In severe cases, renal impairment, metabolic acidosis, or respiratory depression may occur. There is no specific antidote for mesalamine overdose. Treatment is supportive and symptomatic, including gastric lavage if presented early and adequate hydration to maintain renal function. Hemodialysis may be considered in severe cases, though mesalamine protein binding may limit effectiveness. Contact poison control center or seek immediate medical attention for suspected overdose.
Storage
Store at room temperature (20-25°C or 68-77°F) in the original container with the lid tightly closed. Protect from moisture and light. Do not remove desiccant from the bottle. Keep out of reach of children and pets. Do not use tablets that show signs of moisture damage or discoloration. Proper storage ensures stability of the pH-dependent coating that is essential for targeted drug delivery.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Individual treatment decisions should be made in consultation with a qualified healthcare professional based on specific clinical circumstances. Dosage and administration may vary based on individual patient factors. Always follow the prescribing information provided by the manufacturer and the instructions of your healthcare provider. Report any adverse effects to your physician promptly.
Reviews
Clinical studies have demonstrated that approximately 60-70% of patients with mild to moderate ulcerative colitis achieve clinical improvement with Asacol therapy, with sigmoidoscopic improvement observed in 50-60% of patients. Maintenance therapy has shown relapse prevention in approximately 70-80% of patients at 6 months compared to 20-30% with placebo. Many gastroenterologists consider mesalamine preparations like Asacol the cornerstone of mild to moderate ulcerative colitis management due to their favorable efficacy-to-safety profile. Patient-reported outcomes often indicate improvement in quality of life measures related to reduced symptom frequency and severity.
