Generic Asacol (Mesalamine)

Introduction

Asacol is an oral medication whose active ingredient is mesalamine, a 5-aminosalicylic acid (5-ASA) compound. It is formulated as a 400 mg tablet and belongs to the class of aminosalicylates, which are used primarily to treat inflammatory bowel disease (IBD). The drug is approved for maintenance therapy of ulcerative colitis and for induction of remission in mild-to-moderate ulcerative colitis. In addition, mesalamine is sometimes employed off-label for other gastrointestinal conditions, although such uses are not formally sanctioned by regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

What is Asacol?

Asacol is a branded formulation of mesalamine, marketed by Salix Pharmaceuticals (now part of Valeant/ Bausch Health). The product is a delayed-release tablet designed to deliver mesalamine throughout the colon, where inflammation in ulcerative colitis predominantly occurs.

• Classification: Aminosalicylate, anti-inflammatory agent for the gastrointestinal tract.
• Development history: Mesalamine was first synthesized in the s as the active moiety of sulfasalazine. Subsequent research created colon-targeted delivery systems, leading to the development of Asacol in the early s.
• Brand landscape: Mesalamine is also marketed under names such as Pentasa, Lialda, and Mezavant. Asacol provides a cost-effective generic alternative that can be obtained through our online pharmacy.

How Asacol Works

Mesalamine exerts its effect by inhibiting the production of pro-inflammatory cytokines (e.g., interleukin-1β, tumor necrosis factor-α) and cyclo-oxygenase pathways within the colonic mucosa. The drug blocks nuclear factor-κB (NF-κB) activation, reducing leukocyte recruitment and oxidative stress. Because the tablet releases the drug slowly, therapeutic concentrations are achieved in the distal intestine and colon, providing local anti-inflammatory activity while minimizing systemic exposure. Onset of symptom relief typically occurs within 2-3 weeks of consistent dosing, and the drug’s half-life in the colon allows once-daily administration for most patients.

Conditions Treated with Asacol

• Ulcerative colitis (maintenance therapy): Asacol helps keep patients in remission by suppressing ongoing mucosal inflammation. Clinical trials have demonstrated a significant reduction in relapse rates compared with placebo (e.g., ACT 1 and ACT 2 studies).
• Ulcerative colitis (induction of mild-to-moderate disease): When taken at the recommended dose, the medication can induce remission in newly diagnosed or flaring patients, shortening the duration of active disease.

The drug’s efficacy stems from its targeted delivery to the colon and its direct modulation of inflammatory pathways specific to ulcerative colitis pathology.

Off-Label and Investigational Uses of Asacol

• Crohn’s disease involving the colon: Small open-label studies have suggested that mesalamine may provide modest benefit in colonic Crohn’s disease, but larger randomized trials have not confirmed a consistent effect.
• Microscopic colitis: Some gastroenterologists prescribe mesalamine for collagenous or lymphocytic colitis based on anecdotal reports and limited case series indicating symptom improvement.
• Chemotherapy-induced colitis: Preliminary research indicates that mesalamine’s anti-inflammatory properties could mitigate mucosal injury from certain chemotherapeutic agents, though evidence remains early-phase.

These applications are not approved by the FDA or EMA. Patients should discuss any off-label consideration with a qualified healthcare professional, as safety and efficacy have not been definitively established.

Is Asacol the Right Medication for You?

Asacol is appropriate for adults with a confirmed diagnosis of ulcerative colitis who require long-term inflammation control. It is especially useful when:

• Disease is limited to the colon (no significant small-intestinal involvement).
• Patients prefer oral therapy over rectal formulations.
• The goal is to minimize systemic steroid exposure.

Contraindications include known hypersensitivity to mesalamine or any tablet excipients, severe renal impairment (eGFR < 30 mL/min/1.73 m²), and patients with a history of sulfa allergy where cross-reactivity is a concern. Use is also discouraged in individuals with acute severe ulcerative colitis requiring hospitalization, as rapid-acting intravenous therapies are preferred in that setting.

Risks, Side Effects, and Interactions

Common

• Headache
• Nausea or mild abdominal discomfort
• Flatulence
• Diarrhea (often transient during initiation)

Rare

• Pancreatitis
• Arthralgia or myalgia
• Photosensitivity rash

Serious

• Severe hypersensitivity reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Interstitial nephritis or worsening renal function
• Hepatotoxicity (elevated transaminases)

Drug-Drug Interactions

• Non-steroidal anti-inflammatory drugs (NSAIDs): May increase risk of renal toxicity.
• Anticoagulants (e.g., warfarin): Mesalamine can potentiate anticoagulant effect; monitor INR closely.
• Probenecid: Can raise mesalamine plasma concentrations, heightening side-effect risk.

Drug-Food Interactions

• No specific foods are known to alter mesalamine absorption, but taking the tablet with a full glass of water improves tablet coating integrity. Alcohol does not interfere directly but can aggravate gastrointestinal symptoms.

Patients should report any signs of renal impairment (reduced urine output, swelling) or severe skin reactions promptly.

Use: Dosing, Missed Dose, Overdose

• Standard dosing: The usual maintenance dose for ulcerative colitis is 2.4 g to 4.8 g per day, divided into 1-2 tablets of 400 mg each. Induction regimens may start at the higher end of this range. Dosage adjustments are recommended for patients with renal insufficiency.

• Missed dose: If a dose is forgotten and the scheduled time is less than 12 hours away, take the missed tablet as soon as remembered. If the next dose is imminent, skip the missed tablet and continue with the regular schedule. Do not double-dose.

• Suspected overdose: Symptoms may include severe nausea, vomiting, abdominal pain, or dizziness. Seek medical attention immediately; supportive care is the primary treatment.

• Practical precautions:

  • Swallow tablets whole; do not crush or chew, as this compromises the delayed-release coating.
  • The medication can be taken with or without food; consistent intake with water is recommended.
  • Operating heavy machinery is generally safe, but patients experiencing dizziness should exercise caution.

FAQ

• What is the best way to store Asacol tablets? Store at room temperature (15-30 °C) away from moisture and direct sunlight. Do not refrigerate; the delayed-release coating may be compromised by humidity.

• Can I travel internationally with Asacol? Yes. Keep the medication in its original packaging with the prescription label (if applicable) and a copy of the medication facts sheet. Some countries require a doctor’s note for chronic GI drugs, so check entry requirements ahead of time.

• Does Asacol contain any allergens such as gluten or lactose? The tablet formulation includes inactive ingredients like microcrystalline cellulose, magnesium stearate, and silicon dioxide. It is free of gluten, lactose, and common food allergens.

• How long does it take for Asacol to reach steady-state levels in the colon? Steady-state concentrations are typically achieved after 5-7 days of consistent daily dosing, given the drug’s delayed-release design and colonic transit time.

• Are there any gender-specific considerations for Asacol? No dosing differences are required based on sex. However, women who are pregnant or breastfeeding should only use mesalamine if the potential benefit outweighs any uncertain risk, as data are limited.

• What laboratory tests should be monitored while on Asacol? Baseline and periodic renal function tests (serum creatinine, eGFR) and liver enzymes are recommended, especially in patients with pre-existing impairment.

• Can Asacol be taken with probiotic supplements? Probiotics do not interfere with mesalamine’s mechanism and can be safely co-administered. Some clinicians advise separating the doses by at least two hours for optimal colonic delivery.

• Why does Asacol sometimes cause a temporary increase in diarrhea when first started? The delayed-release coating may initially release higher local concentrations of mesalamine, causing mild irritation. This effect usually subsides within a week as the mucosa adapts.

• Is there a difference between Asacol and other mesalamine brands in terms of efficacy? Comparative studies suggest similar overall efficacy for ulcerative colitis when dosing is equivalent. Differences lie mainly in release technology (pH-dependent vs. time-dependent) and patient tolerance of the tablet size.

• What should I do if I experience a rash while using Asacol? Discontinue the medication and seek medical evaluation. A rash may signal a hypersensitivity reaction, which can progress to serious skin conditions if untreated.

• Does Asacol interact with over-the-counter antacids? Antacids do not significantly affect mesalamine absorption, but taking them at the same time may alter gastric pH. For simplicity, separate their ingestion by at least 30 minutes.

Glossary

5-ASA (5-Aminosalicylic Acid)

The active anti-inflammatory component of mesalamine, targeting cytokine production in the colon.

Delayed-Release Tablet

A formulation that resists dissolution in the stomach and releases the drug further along the gastrointestinal tract, usually in the small intestine or colon.

eGFR (Estimated Glomerular Filtration Rate)

A calculated measure of kidney function used to adjust dosing of renally excreted medications.

Buying Asacol from Our Online Pharmacy

Patients who need reliable, affordable access to mesalamine can obtain Asacol through our online pharmacy. By partnering with licensed overseas suppliers, we source the medication at prices close to the manufacturing cost, passing the savings directly to you.

• Cost-effectiveness: Generic mesalamine tablets are offered at a fraction of the retail price found in many brick-and-mortuary pharmacies.
• Verified quality: Every batch is procured from FDA-registered manufacturers and undergoes third-party testing for purity and potency.
• Secure, discreet delivery: Orders are packaged in unmarked parcels and shipped via express (≈ 7 days) or regular airmail (≈ 3 weeks) services, ensuring privacy and reliability.

Our pharmacy broker model allows us to serve patients who face geographic barriers, insurance limitations, or limited stock in local pharmacies. The process is straightforward, confidential, and designed to complement the care you receive from your healthcare provider.

Disclaimer

The information presented about Asacol is intended for general educational purposes only and does not replace professional medical advice. All therapeutic decisions, including those concerning off-label applications, should be made under the supervision of a qualified healthcare provider. Readers are presumed to be responsible adults capable of evaluating health information critically. Our online pharmacy supplies Asacol to individuals who may encounter limited availability through conventional pharmacy channels or who are seeking cost-effective generic alternatives. Always consult your physician before initiating, modifying, or discontinuing any medication.