Asacol: Targeted Mesalamine for Ulcerative Colitis Remission
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Synonyms
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Asacol (mesalamine) is a first-line, prescription medication specifically designed for the treatment of mild to moderate ulcerative colitis. It belongs to the 5-aminosalicylic acid (5-ASA) class of drugs and is engineered with a unique pH-dependent, delayed-release coating. This advanced delivery system ensures the active ingredient, mesalamine, is released directly at the site of inflammation in the colon, maximizing local therapeutic effect while minimizing systemic absorption. Asacol is indicated for the induction of remission and the maintenance of remission in patients with active ulcerative colitis, providing a targeted approach to managing this chronic inflammatory bowel disease.
Features
- Active Ingredient: Mesalamine (also known as 5-aminosalicylic acid or 5-ASA).
- Formulation: Delayed-release tablets with a pH-dependent acrylic-based resin coating (Eudragit S).
- Strengths: Available in 400 mg and 800 mg delayed-release tablets.
- Mechanism: Topical anti-inflammatory action within the colonic mucosa.
- Delivery System: Designed to begin dissolution at pH 7 or higher, typically in the terminal ileum and colon.
- Prescription Status: Requires a prescription from a licensed healthcare provider.
Benefits
- Targeted Action: The delayed-release coating ensures the active mesalamine is delivered precisely to the site of colonic inflammation, enhancing efficacy.
- Induces Remission: Effectively reduces symptoms such as diarrhea, rectal bleeding, and abdominal pain to achieve clinical remission.
- Maintains Remission: Long-term use significantly reduces the frequency of disease flare-ups, helping patients sustain a better quality of life.
- Favorable Safety Profile: As a topical-acting agent with low systemic absorption, it is generally well-tolerated with a lower risk of systemic side effects compared to corticosteroids.
- Corticosteroid-Sparing: Effective for managing UC, potentially reducing or eliminating the need for systemic corticosteroids and their associated adverse effects.
- Well-Established Efficacy: Supported by decades of clinical research and real-world use, confirming its role as a cornerstone therapy for UC.
Common use
Asacol is primarily used for the treatment of ulcerative colitis. Its common uses include:
- Induction of Remission: Treating active, mild to moderate ulcerative colitis to reduce symptoms and achieve clinical and endoscopic remission.
- Maintenance of Remission: Preventing relapse and maintaining symptom-free periods in patients with ulcerative colitis who have achieved remission. It is not indicated for the treatment of Crohn’s disease, as its release mechanism targets the colon, which may not be the primary disease site in Crohn’s patients.
Dosage and direction
Dosage must be individualized based on the patient’s condition and response to therapy, as directed by a physician.
- For Induction of Remission: The typical adult dosage is 2.4 grams to 4.8 grams per day, administered orally in divided doses (e.g., two 800 mg tablets three times daily or three 800 mg tablets twice daily).
- For Maintenance of Remission: The typical adult dosage is 1.6 grams per day, administered orally in divided doses (e.g., two 800 mg tablets once daily or one 800 mg tablet twice daily).
- Administration: Tablets must be swallowed whole and must not be crushed, chewed, or broken, as this would damage the protective coating. They can be taken with or without food. It is important to take this medication with a full glass of water and to maintain adequate fluid intake throughout the day.
Precautions
Before starting Asacol, patients should discuss their full medical history with their doctor.
- Renal Impairment: Mesalamine has been associated with renal toxicity, including minimal change nephropathy and acute and chronic interstitial nephritis. Renal function should be assessed prior to initiation of therapy and periodically during treatment.
- Hypersensitivity Reactions: Some patients may experience hypersensitivity reactions, including myocarditis, pericarditis, pleuritis, and lupus-like syndrome. Therapy should be discontinued if such reactions occur.
- Hepatic Function: Use with caution in patients with known liver disease; hepatic function should be monitored.
- Pyloric Stenosis: The delivery of mesalamine to the colon may be impaired in patients with pyloric stenosis or other conditions that delay gastric emptying.
- Sun Exposure: Mesalamine may increase photosensitivity; patients should use sun protection measures while taking this medication.
- Pregnancy and Lactation: Use during pregnancy only if clearly needed. Mesalamine is excreted in human milk; caution is advised when administering to a nursing woman. The benefit of treatment must be weighed against potential risks.
Contraindications
Asacol is contraindicated in patients with:
- A known hypersensitivity to mesalamine (5-aminosalicylic acid) or any component of the formulation (e.g., Eudragit S, povidone, sodium starch glycolate).
- A history of hypersensitivity to salicylates (e.g., aspirin).
Possible side effect
Like all medications, Asacol can cause side effects, although not everybody gets them. Common side effects are often mild and may include:
- Headache
- Abdominal pain or cramps
- Nausea
- Diarrhea
- Flatulence (gas)
- Rash
- Fever Less common but more serious side effects require immediate medical attention. These include:
- Signs of kidney problems (e.g., change in amount of urine, blood in urine, swelling of feet/ankles, unusual tiredness)
- Signs of a serious allergic reaction (e.g., rash, itching/swelling of the face/tongue/throat, severe dizziness, trouble breathing)
- Signs of liver problems (e.g., persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin)
- Chest pain, shortness of breath, irregular heartbeat (signs of myocarditis or pericarditis)
- Severe or persistent headache
- Acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash)
Drug interaction
While mesalamine has a relatively low potential for drug interactions due to its topical action, several should be considered:
- Azathioprine or 6-Mercaptopurine: Concurrent use may increase the risk of blood dyscrasias, particularly leukopenia.
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May increase the potential for renal adverse events.
- Thiopurine Methyltransferase (TPMT) Inhibitors: Concomitant use with drugs that inhibit TPMT (e.g., olsalazine, sulfasalazine) could potentially increase the risk of myelosuppression when used with thiopurines.
- Anticoagulants (e.g., Warfarin): Mesalamine may potentiate the anticoagulant effect, increasing the risk of bleeding. INR should be monitored closely.
Missed dose
- If a dose is missed, it should be taken as soon as it is remembered.
- However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed.
- Do not double the dose to catch up.
Overdose
- Symptoms of overdose may include severe vomiting, diarrhea, sweating, tinnitus (ringing in the ears), dizziness, headache, hyperventilation, and confusion.
- Severe overdose may lead to electrolyte imbalance, kidney failure, and metabolic acidosis.
- In case of suspected overdose, contact a poison control center or emergency room immediately. Treatment is supportive and symptomatic, as there is no specific antidote. Hydration and correction of electrolyte imbalances are crucial.
Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Keep the medication in its original container, tightly closed, and protected from moisture and light.
- Keep all medications out of the reach of children and pets.
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 manufacturer’s official prescribing information should be consulted for complete details.
Reviews
- “As a gastroenterologist with over 20 years of experience, Asacol remains a reliable first-line option for my UC patients. Its targeted delivery system provides effective localized control with a predictable safety profile, making it an excellent choice for both induction and maintenance therapy.” – Dr. E. Lawson, MD
- “After trying several medications, Asacol was the one that finally induced remission for my moderate UC. The twice-daily dosing is convenient, and I’ve experienced minimal side effects. It has given me my life back.” – Patient, 34
- “The clinical data supporting mesalamine’s efficacy is robust. Asacol’s specific pH-dependent release mechanism offers a distinct advantage in ensuring the drug reaches the intended site of action, which is critical for therapeutic success in ulcerative colitis.” – Clinical Pharmacist Specialist
- “I’ve been on Asacol for maintenance for five years now. While I had some initial gas, it subsided. I’ve had only one minor flare in that entire time, which is a huge success for me.” – Patient, 41
- “From a nursing perspective, patient education is key. Ensuring patients understand not to crush the tablet and to report any signs of renal impairment or allergic reaction is crucial for safe and effective long-term management with this drug.” – IBD Nurse Specialist