Asacol HD

The active ingredient in Asacol HD is mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA), which works locally on the lining of the digestive tract to reduce inflammation. It is believed that this action is achieved through cyclooxygenase and prostaglandin inhibition in the colon.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Asacol HD. However, the following is a synopsis of the general guidelines for the use of Asacol HD:

1. It should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

2. Swallow the tablets whole, and do not cut, break, crush, or chew them.

3. If you are unable to swallow the capsule whole, it can be opened up carefully, and the four tablets within can be swallowed whole.

4. Ensure you drink lots of water while on this medication.

5. If you see intact, partially intact, or tablet shells frequently in your stool, contact your healthcare provider.

6. Protect the Asacol HD tablets from moisture.

The most common side effects of Asacol HD include:

• Belching.
• Abdominal pain.
• Sore throat.
• Constipation.
• Dizziness.
• Runny nose.
• Back pain.
• Rash.

Some individuals may experience serious side effects while using Asacol HD. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Mesalamine-induced Acute Intolerance Syndrome may present with similar symptoms of an acute ulcerative colitis exacerbation. While on this treatment, self-monitor for worsening symptoms, and let your physician know immediately if this occurs. Symptoms include cramping, severe stomach pain, bloody diarrhea, fever, headache, malaise, and itchy skin or eyes.

Hypersensitivity reactions can affect the muscles of the heart (myocarditis), the lining of the heart (pericarditis), the kidneys (nephritis), the liver (hepatitis), lungs (pneumonitis), and blood (hematologic abnormalities).

• Severe cutaneous adverse reactions, including Stevens-Johnson syndrome. Symptoms include: severe skin rash, red, swollen, blistered, or peeling skin, wheezing, tightness in the chest or throat, trouble breathing, or swelling of the mouth, face, lips, tongue, or throat.

• Photosensitivity may occur while on this medication. You should take care to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen.

• Kidney stones may also occur with this medication. Ensure to stay well hydrated, and watch for signs of severe abdominal pain, fever, nausea, vomiting, or blood in your urine.

• Kidney disease has also been reported by patients who take this medication. Kidney function should be evaluated before the use of mesalamine tablets.

These are not all of the possible side effects of Asacol HD. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Asacol HD, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions.

• The use of this medication may worsen liver disease or kidney problems.
• Skin conditions such as atopic dermatitis (eczema) may put you at a higher risk of photosensitivity.
• High iron levels, or risk of iron overload, as iron oxide (2.7 mg per capsule) is found in the delayed-release capsules.
• The safety and efficacy of this medication beyond 6 weeks has not been established.
• Elderly patients who use this medication are at an increased risk of low blood cell counts, and their complete blood cell counts, as well as platelets, should be monitored.

Known or suspected hypersensitivity to salicylates or aminosalicylates, or previous severe allergic reactions to sulfa drugs such as sulfasalazine.

This medication takes weeks before the first effect is seen, and several months for the full effect.

When Asacol HD is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, naproxen, and high-dose aspirin. Concurrent use may increase the risk of kidney damage from mesalamine.
• Azathioprine (6-mercaptopurine), which may increase the risk of blood disorders.
• Asacol HD can also interfere with urine and blood tests.

Asacol HD is available as 800mg delayed-release tablets. Of note, two delayed-release 400mg oral products are not interchangeable with one 800 mg tablet.

Mesalamine delayed-release tablets should be stored at controlled room temperature (between 20° to 25° C) in a dry place out of the reach of children or pets.

It is manufactured by Allergan Pharmaceuticals.

Yes, there is a generic version of Asacol HD. It is also available in different formulations under the brand names Pentasa, Delzicol, Apriso, and Lialda.

Other than from the results of severe adverse reactions, this medication should not be stopped suddenly. Talk to your doctor if you think this medication is not working for you.

This medication does cross the placenta but is not known to cause harm to a developing fetus. Further, uncontrolled inflammatory bowel disease is associated with numerous adverse pregnancy outcomes. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Mesalamine is considered safe for a nursing infant, though infants should be monitored for diarrhea. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.