Asacol (mesalamine) is a prescription medication specifically formulated for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. It belongs to the class of 5-aminosalicylic acid (5-ASA) agents and is designed to deliver its active ingredient directly to the site of inflammation in the colon. This targeted action helps reduce inflammation, alleviate symptoms such as diarrhea, rectal bleeding, and abdominal pain, and promote mucosal healing. Asacol is a cornerstone therapy for inducing and maintaining remission in mild to moderate cases.

Features

• Active Ingredient: Mesalamine (also known as 5-aminosalicylic acid or 5-ASA)
• Delivery System: pH-dependent delayed-release tablet designed to begin dissolution in the terminal ileum (at pH ≥7) to target the colon
• Tablet Strength: 400 mg
• Formulation: Oral delayed-release tablets
• Coating: An enteric coating (Eudragit S) protects the medication from dissolution in the stomach and upper small intestine

Benefits

• Localized Anti-inflammatory Action: Delivers the active ingredient directly to the inflamed colonic mucosa, maximizing therapeutic effect where it is needed most while minimizing systemic exposure.
• Symptom Reduction: Effectively reduces the hallmark symptoms of ulcerative colitis, including diarrhea, rectal bleeding, urgency, and abdominal cramping/pain.
• Induction of Remission: Clinically proven to help patients achieve clinical remission, characterized by a significant reduction in symptoms and improved quality of life.
• Maintenance of Remission: Helps sustain periods of disease quiescence, reducing the frequency and severity of disease flare-ups over the long term.
• Mucosal Healing: Contributes to the healing of the damaged intestinal lining, which is a key treatment goal beyond mere symptom control and is associated with better long-term outcomes.
• Generally Favorable Safety Profile: As a topical-acting agent within the GI tract, it has a well-established safety profile, especially when compared to systemic corticosteroids or immunosuppressants.

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. Its primary role is to manage the chronic inflammation characteristic of this condition, helping to control symptoms and prevent future flares.

Dosage and direction

For the treatment of active ulcerative colitis:

• Adults: The typical dosage is 2.4 grams per day, administered orally in divided doses (e.g., two 400 mg tablets three times daily) for a duration of 6 weeks.
• Pediatric patients 5 to 17 years of age: The dosage is based on body weight and should be administered under the supervision of a pediatric gastroenterologist.

For the maintenance of remission of ulcerative colitis:

• Adults: The typical dosage is 1.6 grams per day, administered orally in divided doses (e.g., two 400 mg tablets twice daily).

Administration Instructions:

• Swallow tablets whole and intact; do not crush, break, or chew.
• Administer with a full glass of water.
• Can be taken with or without food.
• It is crucial to follow the specific dosing regimen prescribed by your healthcare provider, as it is tailored to your individual condition.

Precautions

• Renal Function: Mesalamine has been associated with renal toxicity, including rare cases of interstitial nephritis. Your physician should assess renal function (e.g., serum creatinine) prior to initiating therapy and periodically during treatment.
• Hypersensitivity Reactions: Some patients may experience hypersensitivity reactions, including myocarditis, pericarditis, pneumonitis, and hepatitis. Discontinue therapy if such reactions are suspected.
• Acute Intolerance Syndrome: A syndrome resembling a flare of colitis (cramping, acute abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash) may occur; differentiation from a genuine disease flare is necessary.
• Hepatic Function: Use with caution in patients with known liver impairment; monitor liver function tests.
• Sun Exposure: Mesalamine may increase photosensitivity; use sun protection measures while on therapy.
• Phenylketonuria (PKU): Asacol tablets contain aspartame, which is a source of phenylalanine (approximately 0.56 mg per 400 mg tablet).

Contraindications

Asacol is contraindicated in patients with:

• A known hypersensitivity to salicylates (including mesalamine) or any component of the formulation.
• A history of hypersensitivity to sulfasalazine.

Possible side effect

Most side effects are mild and transient. Common side effects may include:

• Headache
• Abdominal pain/cramps
• Nausea
• Diarrhea
• Flatulence
• Rash
• Rhinitis
• Fever
• Dizziness

Serious side effects (require immediate medical attention):

• Signs of kidney problems (e.g., change in urine output, swelling in feet/ankles, unusual fatigue)
• Signs of pancreatitis (e.g., severe and persistent abdominal pain, nausea/vomiting)
• Signs of a serious allergic reaction (e.g., difficulty breathing, swelling of the face/throat, severe dizziness)
• Signs of liver problems (e.g., yellowing eyes/skin, dark urine, severe nausea)
• Signs of blood disorders (e.g., unexplained bruising/bleeding, persistent sore throat/fever)
• Chest pain or palpitations
• Shortness of breath

Drug interaction

• Azathioprine or 6-Mercaptopurine: Concurrent use with mesalamine may increase the potential for blood disorders (myelosuppression).
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs): May increase the potential for nephrotoxicity; concomitant use should be approached with caution.
• Anticoagulants (Warfarin): Mesalamine may potentially enhance the anticoagulant effect, increasing the risk of bleeding. Close monitoring of INR is recommended.
• Lactobacillus and other Probiotics: Some evidence suggests a potential interaction that may reduce the effectiveness of the probiotic.

Missed dose

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.

Overdose

Symptoms of overdose may include severe headache, dizziness, confusion, nausea, vomiting, diarrhea, sweating, tinnitus (ringing in the ears), and hyperventilation. In cases of suspected overdose, contact a poison control center or seek emergency medical attention immediately. There is no specific antidote; treatment is supportive and symptomatic.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Keep the bottle tightly closed and stored in its original container to protect from moisture and light.
• Keep out of reach of children and pets.
• Do not use after the expiration date printed on the bottle.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided may not cover all possible uses, directions, precautions, drug interactions, or adverse effects.

Reviews

• “As a gastroenterologist with over 20 years of experience, Asacol remains a reliable first-line option for my patients with mild to moderate UC. Its targeted delivery system and proven efficacy in both induction and maintenance make it a workhorse in our therapeutic arsenal.” – Dr. A., MD
• “After my diagnosis, my doctor started me on Asacol. It took a few weeks, but the bleeding and urgency finally subsided. I’ve been in remission for over a year now by sticking with my maintenance dose. It’s given me my life back.” – Sarah T.
• “While effective for my symptoms, I did experience some initial headaches and nausea. These side effects diminished after the first couple of weeks. The convenience of the tablet form is a major plus.” – Mark R.
• “As a clinical pharmacist, I appreciate the well-defined pharmacokinetics of Asacol. Counseling patients on the importance of not crushing the tablet and monitoring for renal and hepatic parameters is key to safe and effective use.” – James L., PharmD
• “We tried Asacol for our teenage son. It was difficult to get him to swallow the pills whole at first, but the improvement in his symptoms was significant. Regular blood tests are part of our routine to ensure everything is okay.” – Parent of a patient