Asacol: Targeted Relief for Ulcerative Colitis Symptoms
Asacol
| 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 aminosalicylates and works locally in the colon to reduce inflammation, helping to induce and maintain remission. This delayed-release formulation ensures the active ingredient is delivered directly to the site of disease activity, minimizing systemic absorption and optimizing therapeutic efficacy for appropriate patients under medical supervision.
Features
- Active ingredient: Mesalamine (5-aminosalicylic acid or 5-ASA)
- 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, typically in the terminal ileum and colon
- Designed to minimize systemic absorption while maximizing local anti-inflammatory effects
Benefits
- Effectively reduces inflammation in the colon to control ulcerative colitis symptoms
- Helps achieve and maintain clinical remission in mild to moderate cases
- Targeted delivery system minimizes systemic exposure and potential side effects
- Demonstrated efficacy in reducing relapse rates when used as maintenance therapy
- Generally well-tolerated with a favorable safety profile compared to systemic therapies
- Convenient oral administration that supports long-term treatment adherence
Common use
Asacol is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. It is also used for the maintenance of remission of ulcerative colitis in adults. The medication is specifically designed for conditions affecting the colon, where its delayed-release mechanism ensures optimal delivery of mesalamine to the inflamed mucosal tissue. Clinical studies have demonstrated its effectiveness in reducing symptoms such as diarrhea, rectal bleeding, and abdominal pain while promoting mucosal healing.
Dosage and direction
For the treatment of active ulcerative colitis in adults: The usual dosage is 2.4 grams per day administered orally in divided doses (800 mg tablet three times daily or 400 mg tablet dosing as directed) for 6 weeks. For maintenance of remission of ulcerative colitis in adults: The usual dosage is 1.6 grams per day administered orally in divided doses. Pediatric dosing (5 years and older) for active ulcerative colitis is weight-based and should be determined by a healthcare provider. Tablets should be swallowed whole and not crushed, chewed, or broken, as this would compromise the delayed-release mechanism. Administration with food may help reduce potential gastrointestinal discomfort.
Precautions
Patients should inform their healthcare provider of any kidney disease or history of kidney problems before starting Asacol, as mesalamine has been associated with renal toxicity. Regular monitoring of renal function through blood tests is recommended during treatment. Those with pyloric stenosis may experience delayed gastric emptying, which could affect drug delivery. Patients with sensitivity to salicylates should use caution. Hepatic function should be monitored in patients with pre-existing liver disease. Sun exposure should be limited due to potential photosensitivity reactions. Any signs of acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) should be reported immediately.
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 (glomerular filtration rate <30 mL/min/1.73m²). The medication is contraindicated in patients with a history of hypersensitivity reactions to sulfasalazine. Those with active peptic ulcer disease should avoid use until the condition is properly managed.
Possible side effects
Common side effects (≥2% of patients) include: headache, abdominal pain, eructation, nausea, diarrhea, vomiting, rash, flatulence, and fever. Less common but potentially serious side effects may include: acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash), renal impairment (including minimal change nephropathy, interstitial nephritis, and renal failure), hepatic reactions (elevated liver enzymes, hepatitis, jaundice), pancreatitis, pericarditis, myocarditis, pneumonitis, and blood dyscrasias (including leukopenia, neutropenia, thrombocytopenia, aplastic anemia). Any unusual symptoms should be reported to a healthcare provider promptly.
Drug interaction
Mesalamine may potentiate the effects of anticoagulants like warfarin, increasing the risk of bleeding—frequent monitoring of INR is recommended. Concurrent use with azathioprine or 6-mercaptopurine may increase the risk of blood disorders. Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal adverse effects when used with mesalamine. The medication may interfere with the absorption of digoxin, thyroid medications, and certain antibiotics. Proton pump inhibitors that increase gastric pH may affect the delayed-release mechanism of Asacol tablets.
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, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed one. Consistency in dosing is important for maintaining therapeutic levels in the colon, but occasional missed doses are unlikely to significantly impact overall treatment efficacy when the regular schedule is promptly resumed.
Overdose
In case of suspected overdose, medical attention should be sought immediately. Symptoms of mesalamine overdose may include nausea, vomiting, diarrhea, sweating, tinnitus, hyperventilation, vertigo, and metabolic acidosis. Severe overdose may lead to renal failure, seizures, or cardiovascular collapse. There is no specific antidote for mesalamine overdose; treatment is supportive and symptomatic. Hemodialysis may be considered in severe cases, though the extent of mesalamine removal through dialysis is variable due to its high protein binding.
Storage
Asacol tablets should be stored at room temperature (20-25°C or 68-77°F) with excursions permitted between 15-30°C (59-86°F). The medication should be kept in its original container with the lid tightly closed to protect from moisture and light. Tablets should not be stored in bathroom cabinets where humidity levels fluctuate. Keep out of reach of children and pets. Do not use tablets that show signs of damage to the coating or appear discolored. Proper storage ensures maintenance of the delayed-release properties throughout the product’s shelf life.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Asacol is a prescription medication that should only be used under the supervision of a qualified healthcare professional. Individual response to treatment may vary, and the prescribing physician will determine the appropriate dosage and duration based on the patient’s specific condition, medical history, and response to therapy. Patients should not adjust their dosage or discontinue treatment without consulting their healthcare provider. Always read the accompanying patient information leaflet for complete details.
Reviews
Clinical studies have demonstrated that Asacol is effective in inducing remission in approximately 50-60% of patients with mild to moderate ulcerative colitis after 6 weeks of treatment. Maintenance therapy with Asacol has shown to keep approximately 70-80% of patients in remission at one year compared to 20-30% with placebo. Many gastroenterologists consider mesalamine products like Asacol as first-line therapy for mild to moderate ulcerative colitis due to their favorable efficacy-to-safety ratio. Patient-reported outcomes often indicate improvements in quality of life measures, including reduced symptom burden and decreased disease-related anxiety. Long-term real-world evidence supports its role in maintaining mucosal healing and preventing disease complications when used consistently as prescribed.