Generic Asacol ( Mesalamine )

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Asacol (Mesalamine 400 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Asacol is an anti-inflammatory medication used to treat inflammatory bowel disease, particularly ulcerative colitis. It works directly on the lining of the intestine to reduce inflammation. The exact way it works is not fully understood, but it is believed to block the production of substances in the body that cause inflammation, such as prostaglandins. Because it acts locally in the gut, it has fewer systemic side effects than some other anti-inflammatory drugs.

For specialists: The mechanism of action of mesalamine is not fully understood, but it appears to be topical rather than systemic. Mesalamine acts locally on the colonic epithelial cells to diminish inflammation. It is thought to block cyclooxygenase and inhibit prostaglandin production in the colon. Recent data also suggest that mesalamine can inhibit the activation of nuclear factor-kappa B (NF-κB) in the intestinal mucosa. Other proposed mechanisms include activation of the gamma form of peroxisome proliferator-activated receptors (PPAR-γ), inhibition of leukocyte chemotaxis, and scavenging of reactive oxygen species.

Pharmacokinetics

• Absorption: Mesalamine is administered orally as a delayed-release (enteric-coated) tablet. The enteric coating prevents release of the drug in the stomach, allowing it to reach the colon intact. Approximately 20 to 30% of an oral dose is absorbed systemically. Food may delay the time to peak concentration but does not significantly affect the extent of absorption.
• Metabolism: Absorbed mesalamine is rapidly and extensively metabolized in the liver and intestinal wall to N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), which is the primary metabolite and is considered pharmacologically inactive. The acetylation process is not dependent on acetylator phenotype.
• Elimination: The major route of elimination is via the feces, primarily as unchanged mesalamine. Absorbed mesalamine and its metabolite are excreted mainly in the urine. The elimination half-life is approximately 0.5 to 1.5 hours for mesalamine and 5 to 10 hours for N-Ac-5-ASA.
• Onset of Action: Symptomatic improvement in ulcerative colitis is typically observed within 1 to 2 weeks, but full therapeutic effect may take up to 6 weeks.
• Duration of Action: The anti-inflammatory effect is maintained with continued daily dosing. Mesalamine is used for both induction of remission and maintenance therapy.

Uses in Daily Life and Best Practice Advice

Mesalamine is prescribed in Canada for the treatment of inflammatory bowel disease. Your physician will determine the appropriate use and dose based on your specific condition and medical history.

• Typical Uses: Treatment of mildly to moderately active ulcerative colitis (induction of remission) in adults; maintenance of remission of ulcerative colitis in adults; prevention of relapse of Crohn's disease in patients following bowel resection.
• Administration: Swallow the tablet whole with a full glass of water. Do not chew, crush, or break the tablet, as this will destroy the delayed-release coating and reduce effectiveness. The tablet should be taken with food.
• Monitoring: Your physician will monitor your response to treatment and may perform periodic blood tests to check kidney and liver function. If your symptoms do not improve or worsen, consult your physician.
• Do Not Stop Without Medical Advice: Do not stop taking mesalamine without consulting your physician, as this may lead to a flare-up of your condition.

Morning vs. Evening Dosing

Mesalamine is typically taken three times daily or as directed by your physician. The dosing schedule depends on the specific product and the indication being treated. For Asacol 400 mg tablets, the usual dosing is two tablets three times daily for active disease and one tablet three times daily for maintenance. There is no specific clinical recommendation for morning versus evening dosing, but taking it with meals helps with consistency and reduces the risk of gastrointestinal upset. Always follow the schedule recommended by your physician.

• Divided Dosing: When taken three times daily, the doses are usually taken at mealtimes.
• Consistency: Take mesalamine at the same times each day to ensure consistent effects.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
• Professional Guidance: Your healthcare provider may adjust the frequency and timing based on your response to treatment and other medications.

Administration With or Without Food

Mesalamine should be taken with food. Taking it with a meal helps reduce the risk of stomach upset and may improve absorption consistency. The delayed-release coating is designed to release the medication in the colon, and food can affect the transit time through the gastrointestinal tract.

• Take the tablet with a meal or snack.
• Swallow the tablet whole with a full glass of water.
• Do not chew, crush, or break the tablet, as this will destroy the delayed-release coating.
• If you have difficulty swallowing tablets, consult your pharmacist about alternative formulations of mesalamine that may be easier to take.
• Do not take antacids within 2 hours of taking mesalamine, as they may affect the release of the medication.

Interaction Warnings

Indications for Mesalamine

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition. Health Canada has not authorized an indication for pediatric use, but pediatric dosing based on weight is used in clinical practice. The dosage can be adjusted in accordance with the response to treatment.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take mesalamine exactly as prescribed by your physician. Do not change your dose without medical advice.
• Swallow the tablet whole with a full glass of water. Do not chew, crush, or break the tablet, as this will destroy the delayed-release coating.
• Take the tablet with food to reduce the risk of stomach upset.
• Do not take antacids within 2 hours of taking mesalamine.
• Do not stop taking this medication without consulting your physician, as this may lead to a flare-up of your condition.
• Keep all medical appointments for monitoring of kidney function, liver function, and blood counts.
• Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking mesalamine.
• If you are pregnant, planning to become pregnant, or breastfeeding, consult your physician before use.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
• Store at room temperature in a dry place. Keep out of reach of children.

Alternative Treatment Options

• Sulfasalazine (Salazopyrin): A prodrug of mesalamine combined with sulfapyridine. It is effective for ulcerative colitis and Crohn's disease but has a higher incidence of side effects, particularly gastrointestinal intolerance and hypersensitivity reactions. Requires folic acid supplementation.
• Balsalazide (Colazal): A prodrug of mesalamine linked to an inert carrier. It delivers mesalamine to the colon and is effective for mildly to moderately active ulcerative colitis. May be better tolerated than sulfasalazine.
• Olsalazine (Dipentum): A dimer of two mesalamine molecules. It is effective for maintenance of remission of ulcerative colitis but can cause diarrhea in a significant proportion of patients.
• Corticosteroids (e.g., prednisone, budesonide): Used for moderate to severe flares of ulcerative colitis and Crohn's disease. Effective for rapid induction of remission but not suitable for long-term maintenance due to significant side effects.
• Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate): Used for maintenance of remission in patients who do not respond adequately to mesalamine or who have moderate to severe disease.
• Biologic Agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab): Targeted therapies for moderate to severe inflammatory bowel disease that has not responded to conventional treatments.

Comparison: Mesalamine is the first-line therapy for mild to moderately active ulcerative colitis and for maintenance of remission. It is distinguished from sulfasalazine by its better tolerability profile, as it does not contain the sulfapyridine component that is responsible for many of the adverse effects of sulfasalazine. Mesalamine is available in multiple formulations that target different parts of the gastrointestinal tract, allowing for tailored therapy. For patients who cannot tolerate mesalamine, balsalazide or olsalazine may be considered. Corticosteroids are reserved for more severe flares and are not used for long-term maintenance. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

• Registration: Mesalamine is authorized for sale in Canada by Health Canada as a prescription drug. The brand-name Asacol 400 mg tablet (DIN 01997580) was cancelled post-market in 2020 due to manufacturing issues and the closure of the manufacturing site. Generic mesalamine 400 mg enteric-coated tablets remain available from multiple manufacturers, including Teva Canada (TEVA-5 ASA, DIN 02171929) and Pendopharm (PENDO-5 ASA, DIN 02265257). Teva Canada received a Notice of Compliance for a generic mesalamine product, and Tillotts Pharma AG received approval for a mesalamine delayed-release tablet (DIN 02552426) in 2025.
• Prescription Status: Prescription only in Canada.
• Coverage: Coverage varies by province, territory, and private insurance plan. In Ontario, mesalamine (Mezavant) is listed on the Ontario Drug Benefit Formulary as a General Benefit. In Manitoba, TEVA-5-ASA 400 mg enteric-coated tablets are listed as a Part 1 Benefit. In Quebec, mesalamine products are covered under the RAMQ formulary. Generic formulations are generally more affordable than brand-name products.
• Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program.

Recent Research and Clinical Guidelines (2022–2026)

• The 2025 German clinical practice guidelines (updated) recommend mesalamine ≥1000 mg/day as a suppository for mild to moderately active proctitis. For maintenance of remission in ulcerative colitis, mesalamine is recommended as the primary therapy.
• Current clinical practice guidelines recommend combination therapy with oral mesalamine ≥2.4 g/day plus topical mesalamine ≥1 g/day as the most effective first-line approach for mild to moderate ulcerative colitis flares, superior to either agent alone.
• A drug shortage of TEVA-5 ASA 400 mg tablets was reported in October 2025 and again in January 2026 due to manufacturing disruptions. The shortage was resolved with an anticipated end date in early 2026.
• Teva 5-ASA 400 mg tablets were subject to a recall in April 2025 due to out-of-specification dissolution results. The recall affected specific lots (100048018, 100037651, 100037650, 100053047).
• Health Canada approved Zydus Lifesciences' generic mesalamine suppositories 1000 mg in October 2025 for the treatment of ulcerative proctitis.
• Research continues to explore the role of mesalamine in combination with other agents for inflammatory bowel disease, as well as its potential role in preventing colorectal cancer in patients with ulcerative colitis.

Availability and Supply in Canada

Prices and availability may vary by province, territory, and pharmacy. A drug shortage for TEVA-5 ASA 400 mg was reported in 2025 and 2026 but has since been resolved. Generic mesalamine formulations are widely available in Canada and are generally more affordable than brand-name products. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

1. Is Asacol available in Canada?
   The brand-name Asacol 400 mg tablet was cancelled post-market in 2020 due to manufacturing issues. However, generic mesalamine 400 mg enteric-coated tablets are available by prescription from manufacturers including Teva Canada (TEVA-5 ASA) and Pendopharm (PENDO-5 ASA).
2. What is mesalamine used for?
   Mesalamine is used to treat mildly to moderately active ulcerative colitis (to induce remission) and to maintain remission of ulcerative colitis. It is also used to prevent relapse of Crohn's disease following bowel resection.
3. How long does mesalamine take to work?
   Symptomatic improvement in ulcerative colitis is typically observed within 1 to 2 weeks, but full therapeutic effect may take up to 6 weeks. It is important to continue taking the medication as prescribed even if you start to feel better.
4. Can I take mesalamine with food?
   Yes. Mesalamine should be taken with food to reduce the risk of stomach upset. Swallow the tablet whole with a full glass of water. Do not chew, crush, or break the tablet.
5. What should I do if I miss a dose of mesalamine?
   If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
6. Can I stop taking mesalamine if I feel better?
   No. Do not stop taking mesalamine without consulting your physician. Stopping the medication can lead to a flare-up of your condition. Your physician will advise you on the appropriate duration of treatment.
7. What are the serious side effects of mesalamine?
   Serious side effects include kidney problems (including interstitial nephritis and renal failure), severe blood disorders, severe skin reactions, and acute mesalamine intolerance (which may present as worsening of ulcerative colitis with abdominal cramps, fever, severe headache, and rash). Seek immediate medical attention if you experience any of these symptoms.
8. Is mesalamine safe during pregnancy?
   Mesalamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Mesalamine crosses the placental barrier. A single case of neonatal renal failure has been reported after high-dose, long-term maternal use. Consult your physician if you are pregnant or planning to become pregnant.
9. Is mesalamine safe during breastfeeding?
   Mesalamine is excreted in breast milk in small amounts. Reports of diarrhea in breastfed infants exist. Monitor the infant for changes in intestinal activity. If diarrhea develops, breastfeeding should be discontinued. Consult your physician before use.
10. Are there generic versions of mesalamine available in Canada?
    Yes. Generic mesalamine 400 mg enteric-coated tablets are widely available in Canada from multiple manufacturers, including Teva Canada, Pendopharm, Sanis Health, and others. Generic versions are generally more affordable than brand-name products.

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