Why is this medication prescribed?

Asacol HD (Generic Mesalamine) is primarily prescribed to treat and maintain remission of mildly to moderately active ulcerative colitis, which is an inflammatory bowel disease (IBD) that causes inflammation and ulcers in the lining of the colon and rectum. Mesalamine, the active ingredient in Asacol HD, works by reducing inflammation in the colon, helping to alleviate symptoms such as diarrhea, rectal bleeding, and abdominal pain.

How should this medicine be used?

Asacol HD should be used according to your doctor’s instructions. Here are general guidelines for its use:

• Dosage and Administration: The usual dosage for inducing remission in adults with ulcerative colitis is 1600 mg (two 800 mg tablets) three times daily (for a total daily dose of 4800 mg) for up to 6 weeks. The dosage may differ based on your condition, response to treatment, and doctor’s recommendation.
• Take as Directed: Swallow the tablets whole with a full glass of water. Do not crush, break, or chew the tablets. The coating is designed to ensure that the medication is released in the colon.
• Timing: Take the medication preferably at the same time each day to maintain an even level of the drug in your body.
• With or Without Food: Asacol HD can be taken with or without food, according to your doctor’s instructions.
• Avoid Certain Actions: Do not take Asacol HD with antacids. They can affect the release mechanism of the tablets, making the medication less effective.
• Follow the Doctor’s Instructions: Always follow the specific dosage instructions provided by your healthcare provider, including the duration of therapy.
• Missed Dose: If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not double the dose to make up for a missed one.
• Hydration: Drink plenty of fluids while taking Asacol HD to help prevent kidney stones, a potential side effect of mesalamine.

Always follow your healthcare provider’s specific instructions and consult them if you have any questions or experience side effects.

Other uses for this medicine

While Asacol HD is primarily used to treat and maintain remission in ulcerative colitis, it may also be used for other conditions, such as:

• Crohn’s Disease: Although not specifically approved for this use, mesalamine may be used off-label to treat inflammation associated with mild to moderate Crohn’s disease, another type of inflammatory bowel disease (IBD).
• Proctitis and Proctosigmoiditis: Mesalamine may be prescribed to treat inflammation of the rectum (proctitis) or the rectum and the sigmoid colon (proctosigmoiditis).
• Maintenance Therapy for Ulcerative Colitis: Beyond active treatment, Asacol HD can help maintain remission in patients with ulcerative colitis to prevent flare-ups.

What special precautions should I follow?

Special Precautions for Using Asacol HD:

• Allergic Reactions: Inform your doctor if you are allergic to mesalamine, salicylates (such as aspirin), sulfasalazine, or any other ingredients in Asacol HD.
• Medical History: Discuss your medical history, especially if you have a history of kidney disease, liver disease, heart disease, or any gastrointestinal issues such as pyloric stenosis.
• Pregnancy and Breastfeeding: Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Mesalamine can pass into breast milk and may affect a nursing infant.
• Kidney and Liver Function: Asacol HD may cause kidney or liver problems. Your doctor may need to perform regular blood tests to monitor your kidney and liver function during treatment.
• Heart Conditions: Inform your doctor if you have any heart conditions, as mesalamine can sometimes cause or worsen pericarditis (inflammation of the lining around the heart).
• Stay Hydrated: Drink plenty of fluids while taking Asacol HD to prevent kidney stones or other complications.
• Report New or Worsening Symptoms: Contact your healthcare provider immediately if you experience severe abdominal pain, cramping, blood in the stool, fever, rash, or difficulty breathing.
• Interactions: Tell your doctor about all medications, supplements, and herbal products you are taking, as mesalamine can interact with certain medications, including other anti-inflammatory drugs and blood thinners.

Always follow your healthcare provider’s advice and report any unusual symptoms or concerns while using Asacol HD.

What special dietary instructions should I follow?

• Dietary Restrictions: No specific dietary restrictions are usually required while taking Asacol HD. However, it is essential to follow any specific diet recommended by your healthcare provider, particularly if you have conditions like ulcerative colitis or Crohn’s disease.
• Healthy Diet: Maintain a balanced diet rich in fiber, unless otherwise directed by your doctor, to help manage symptoms of ulcerative colitis.
• Hydration: Stay well-hydrated, especially in cases of diarrhea or during hot weather, to prevent dehydration and support kidney function.

What should I do if I forget a dose?

• Take as Soon as Possible: If you miss a dose, take it as soon as you remember.
• Skip if Close to the Next Dose: If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Avoid Double Dosing: Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Asacol HD (mesalamine) can cause various side effects. While many people tolerate the medication well, here are some potential side effects to be aware of:

Common Side Effects: These side effects are usually mild and may go away as your body adjusts to the medication:

• Nausea or Vomiting
• Diarrhea
• Headache
• Dizziness
• Stomach Pain or Cramps
• Gas or Bloating
• Fatigue

Serious Side Effects: Contact your healthcare provider immediately if you experience any of the following:

• Severe Abdominal Pain or Cramping: Could indicate worsening of colitis or an allergic reaction.
• Bloody or Black Stools: May indicate gastrointestinal bleeding.
• Shortness of Breath, Chest Pain, or Irregular Heartbeat: Could signal a heart problem or an allergic reaction.
• Rash, Itching, or Hives: Signs of an allergic reaction.
• Severe Headache, Fever, or Chills: Could be a sign of an infection or a serious reaction to the medication.
• Yellowing of the Skin or Eyes (Jaundice): May indicate liver problems.
• Dark Urine or Pale Stools: Potential signs of liver issues or a bile duct problem.
• Joint or Muscle Pain: Could be a sign of a drug-induced condition.
• Kidney Problems: Such as pain in the side or lower back, changes in urination, or swelling in the legs or feet.
• Heart Issues: Including pericarditis (inflammation of the lining around the heart).
• Pancreatitis: Symptoms may include severe abdominal pain, nausea, and vomiting.

If you experience any of these serious side effects, seek medical attention immediately.

What should I know about storage and disposal of this medication?

Storage of Asacol HD:

• Keep Asacol HD tablets at room temperature, between 20°C to 25°C (68°F to 77°F).
• Store the medication in its original container, tightly closed, and protected from moisture and light.
• Do not store Asacol HD in the bathroom or any other damp area.
• Make sure the medication is stored in a safe place where children and pets cannot access it.

Disposal of Asacol HD:

• Do not flush Asacol HD down the toilet or pour it into a drain unless instructed to do so.
• When the medication is no longer needed or expired, dispose of it through a medicine take-back program or follow local guidelines for disposal. Consult your pharmacist or local waste disposal authority for more information.

In case of emergency/overdose

• Symptoms of Overdose: Signs may include nausea, vomiting, stomach pain, diarrhea, headache, drowsiness, ringing in the ears, or confusion.
• Call Emergency Services: If someone has collapsed, had a seizure, has trouble breathing, or cannot be awakened, call emergency services immediately (911 in the U.S.).
• Contact Poison Control: For non-emergency situations, call the Poison Control Center at 1-800-222-1222 in the U.S. for guidance.

What other information should I know?

• Follow-Up Appointments: Keep all scheduled follow-up appointments with your healthcare provider to monitor your response to the medication and check for side effects or complications.
• Medication Interactions: Always inform your doctor of all other medications, supplements, or herbal products you are taking, as Asacol HD may interact with other substances.
• Regular Blood Tests: You may need regular blood tests to monitor kidney function, liver function, or other health parameters while taking Asacol HD.
• Allergy Alert: Be aware of any signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or trouble breathing. Seek immediate medical attention if these occur.

By following these guidelines, you can help ensure the effective and safe use of Asacol HD.