Description
Asacol: Effective Relief for Ulcerative Colitis
Asacol is a trusted mesalamine-based medication designed to treat and prevent flare-ups of mild to moderately active ulcerative colitis. By delivering targeted anti-inflammatory action directly to the colon, Asacol helps manage symptoms and maintain remission, improving patients’ quality of life.
Key Features of Asacol
- Targeted Delivery: Each Asacol delayed-release tablet contains 400 mg of mesalamine, an anti-inflammatory drug. The tablets are coated with an acrylic-based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action.
- Proven Efficacy: Asacol is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. It is also indicated for the maintenance of remission of mildly to moderately active ulcerative colitis in adults.
- Flexible Dosage Forms: Available in 400 mg and 800 mg delayed-release tablets, Asacol offers dosing flexibility to meet individual patient needs.
Clinical Performance and Usage Statistics
Asacol has been a mainstay in ulcerative colitis treatment for decades. In 2008, it held a 52% share of the US oral 5-ASA market.
Although specific recent sales data are limited, mesalamine, the active ingredient in Asacol, remains widely prescribed. In 2020, there were approximately 2.95 million prescriptions for mesalamine in the United States, indicating its continued relevance in managing inflammatory bowel diseases.
How Asacol Works
Asacol’s delayed-release formulation ensures that mesalamine is released in the terminal ileum and beyond, directly targeting inflamed areas in the colon. This localized action reduces inflammation, alleviates symptoms, and helps maintain remission in ulcerative colitis patients.
Dosage and Administration
- Adults: For the treatment of mildly to moderately active ulcerative colitis, the recommended dosage is 800 mg (two 400 mg tablets) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks. For maintenance of remission, the recommended dosage is 1.6 grams (four 400 mg tablets) daily in two to four divided doses.
- Pediatric Patients (5 years and older): The recommended total daily dosage is weight-based (up to a maximum of 2.4 grams/day) divided into two daily doses for a duration of 6 weeks.
It’s essential to swallow Asacol tablets whole without cutting, breaking, or chewing them to ensure proper release of the medication. Always consult with a healthcare provider for personalized dosing recommendations.
Safety and Side Effects
Common side effects of Asacol (occurring in ≥5% of patients) include:
- Adults: Eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.
- Pediatric Patients (5 to 17 years old): Nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, and diarrhea.
Serious side effects are rare but may include kidney or liver problems. Regular monitoring by a healthcare professional is recommended during treatment.
Availability and Market Presence
Asacol is available in various countries, including the USA, Canada, Germany, and France. However, there have been recent changes in its availability. Asacol® 400mg MR gastro-resistant tablets (pack size 168) were discontinued in March 2024, and all stocks have now been exhausted. The 400mg MR tablets (pack size 84) were discontinued from April 1, 2024, with stocks expected to be exhausted from late April 2024. Despite these discontinuations, mesalazine (Octasa® MR) 400mg tablets and Asacol® 800mg MR gastro-resistant tablets remain available and can support a full uplift in demand.
FAQs about Asacol
Q: What is Asacol used for?
A: Asacol is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis by reducing inflammation in the colon.
Q: How should I take Asacol?
A: Swallow the tablets whole without cutting, breaking, or chewing them. Follow your healthcare provider’s dosing instructions carefully.
Q: Are there any common side effects?
A: Yes, common side effects include abdominal pain, headache, nausea, and diarrhea. Consult your doctor if any side effects persist or become severe.
Q: Is Asacol available in my country?
A: Asacol is available in several countries, including the USA, Canada, Germany, and France. However, availability may vary, and some formulations have been discontinued. Consult your local pharmacy or healthcare provider for the most current information.
Q: Can children take Asacol?
A: Yes, Asacol is approved for use in children aged 5 years and older for the treatment of mildly to moderately active ulcerative colitis. Dosing is weight-based; consult a pediatrician for appropriate dosing.
Q: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember.
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