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Product description Safety information Side Effects

Drug Name

Asacol (Delayed-Release Tablets)

Drug Uses

Asacol Delayed-Release Tablets are used for treating and causing remission of various forms of mild to moderate ulcerative colitis (inflammation of the colon). Asacol Delayed-Release Tablets may also be used for other conditions as determined by your doctor.

How to use

For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol HD 800 mg tablet.

Take Asacol with a full glass of water.
Asacol can usually be taken with or without food. Follow your doctor's instructions.
Do not crush, break, or chew a Asacol tablet. Swallow the tablet whole.
The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.
Call your doctor if you find undissolved tablets in your stool.
Store Asacol at room temperature away from moisture and heat.

Drug Class and Mechanism

Asacol Delayed-Release Tablets are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause inflammation of the colon.

Missed Dose

If you miss a dose of Asacol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Storage

Store this medicine at room temperature in a tightly-closed container, away from heat and light.

Warnings/Precautions

Do NOT use Asacol Delayed-Release Tablets if:

• you are allergic to any ingredient in Asacol Delayed-Release Tablets, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
• you are younger than 18 years of age and you have the flu or chickenpox, or you have received a live vaccine (eg, varicella, influenza) within the past 6 weeks
• you are taking probenecid or sulfinpyrazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Asacol Delayed-Release Tablets:
Some medical conditions may interact with Asacol Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines (including sulfasalazine), foods, or other substances
• if you have had a stroke, bleeding in the brain, or an aneurysm
• if you have a history of liver or kidney problems, certain stomach problems (pyloric stenosis), pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)
• if you have a history of heart problems (eg, inflammation of the sac around your heart)
• if you have the flu or chickenpox or have recently received a live vaccine (eg, varicella, influenza)

Some MEDICINES MAY INTERACT with Asacol Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Gingko biloba extract because side effects, such as increased bleeding, may occur
• Corticosteroids (eg, prednisone) because they may decrease Asacol Delayed-Release Tablets's effectiveness
• Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Asacol Delayed-Release Tablets
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, spironolactone, or sulfinpyrazone because their effectiveness may be decreased by Asacol Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Asacol Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Possible Side Effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; gas; headache; mild stomach discomfort or pain; nausea; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in the amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

More Information

If you have any questions about Asacol Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Asacol Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.