Lialda (mesalamine)

How is Lialda Used?

Storage

Lialda should be stored between 59°F to 77°F (15°C to 25°C)

How to Take

Lialda should be taken with food. Do not crush, split or chew the tablets. The tablets are coated to prevent the drug from being released before it reaches your lower intestine. Do not change your dosage or take more than you have been prescribed without speaking to your doctor.

Dosage

Lialda is available in a delayed-release tablet with one strength of 1.2 grams.

Dosing for Adults

The recommended starting dose for patients with active ulcerative colitis is 2.4 grams (2 tablets) or 4.8 grams daily (4 tablets).

Once in remission, a maintenance dose of 2.4 grams (2 tablets) is taken daily.

The daily dose should not exceed 4.8 grams per day.

Dosing for Children

Dosing in children is weight-based. The medication can be started when the child is at least 24 kg (52.8 lbs.) and can swallow tablets whole.

Dosing for weeks 0-8 should be administered at:

• For patients 24-35 kg: 2.4 grams by mouth daily.
• For patients >35 to 50 kg: 3.6 grams by mouth daily.
• For patients >50 kg: 4.8 grams by mouth daily.

Dosing after 8 weeks should be administered at:

• For patients 24-35 kg: 1.2 grams by mouth daily.
• For patients >35 kg: 2.4 grams by mouth daily.

Do not exceed these recommended weight-based dosages.

Missed Dose

If you miss a dose of Lialda, take it as soon as you remember. If you remember the next day, skip the missed dose and take your medication at the next scheduled time.

Overdose

If you overdose on Lialda, serious side effects can develop. Symptoms of an overdose can include nausea, vomiting, abdominal pain, abnormally rapid or deep breathing, ringing in the ears, headache, dizziness, confusion, or seizures. In severe cases of overdose kidney and liver damage can occur.

If you suspect an overdose, call 911 or seek care at your local emergency room.

Side Effects

The most common side effects include:

• Abdominal pain
• GI discomfort
• Headache
• Gas
• Nausea
• Fatigue
• Malaise
• Weakness
• Worsening of colitis
• Dizziness
• Rash
• Pruritus
• Acne

Some serious side effects can also occur, seek emergency care if you experience any of the following symptoms:

• Fever of flu-like symptoms
• Swelling of face, mouth, or throat
• Difficulty breathing or swallowing
• Chest pain or shortness of breath
• Black tarry stools or pale stools
• Bloody or black (coffee ground) vomit
• Difficulty or painful urination, pink or red-colored urine.
• Yellowing of the skin and eyes

Warnings and Precautions

Lialda is contraindicated in those who have a known allergy or sensitivity to salicylates or aminosalicylates.

Children

Lialda should not be used in children who weigh less than 24kg and who cannot swallow the tablet whole.

Pregnancy

There is limited data regarding the use of Lialda in pregnancy. Due to the lack of data, Lialda should only be used in pregnancy if the benefit outweighs the risks.

Lactation

Low concentrations of Lialda have been detected in human breastmilk. Diarrhea has been reported in some breastfed infants of mothers taking Lialda. Caution should be used when Lialda is administered to nursing women.

Geriatrics

There is a higher incidence of blood disorders in patients 65 years of age or older taking Lialda. Dosage in these patients should be started low to prevent the frequency of hepatic and renal dysfunction. Blood counts should be monitored routinely in this population while taking the medication.

Renal Impairment

Renal failure has been reported in patients who take Lialda. Caution should be used in patients with known renal impairment or a history of renal disease. It is recommended that patients taking Lialda have a renal function evaluation prior to initiation and periodically while receiving treatment with Lialda.

Mesalamine-Induced Acute Intolerance Syndrome

In some cases, Lialda can cause a systemic reaction that can be confused with an exacerbation of ulcerative colitis. Symptoms include abdominal pain, cramping, bloody diarrhea, headache, rash, and occasionally a fever. Patients should be observed closely for these symptoms while receiving treatment with Lialda. If acute intolerance syndrome is suspected, the use of Lialda should be discontinued immediately.

Hypersensitivity Reactions

Lialda should not be taken by patients who have experienced a hypersensitivity reaction to sulfasalazine. A similar reaction has been seen when taking Lialda.

Myocarditis/Pericarditis

Caution should be used when prescribing Lialda to patients who may have a history or be predisposed to myocarditis or pericarditis.

Hepatic Impairment

Lialda has been linked to hepatic failure in patients with pre-existing liver conditions. Laboratory monitoring should be routine in these patients.

Functional Obstruction of the Upper GI Tract

Pyloric stenosis or other upper GI obstruction can cause prolonged gastric retention that can delay the release of Lialda into the colon. Caution should be used in these cases.

Laboratory Tests

Lialda can cause elevated test results when measuring urinary normetanephrine, alternative testing should be selected.

Drug Interactions

This is not a complete list of potential drug interactions. Before taking Lialda, tell your doctor if you take any medications, herbal supplements, or vitamins.

Non-Steroidal Anti-Inflammatory Drugs

When used in conjunction with Lialda, there is an increased risk of nephrotoxicity. Medications such as ibuprofen and aspirin should be avoided while taking Lialda.

Proton pump inhibitors (PPI)

Lialda should not be taken with a proton pump inhibitor (PPI). PPI’s decrease the effects of Lialda by increasing gastric pH. Medications to avoid include Omeprazole (Prilosec), Esomeprazole (Nexium), Lansoprazole (Prevacid), Rabeprazole (AcipHex), Pantoprazole (Protonix) and Dexlansoprazole (Dexilant)

Nizatidine

Nizatidine is an antacid that decreases the effect of Lialda by increasing gastric pH and should be avoided.

6-mercaptopurine (Purinethol) and Azathioprine

Using these medications in conjunction with Lialda can lead to an increased risk of blood disorders, bone marrow failure, and other similar complications. If concurrent use cannot be avoided, patients need to have routine blood count monitoring.

Antacids

Antacids such as magnesium hydroxide, calcium carbonate, and aluminum hydroxide can reduce the amount of Lialda that is absorbed by the intestines. Antacids should be avoided while taking Lialda.

Measles, Mumps, Rubella, and Varicella Vaccine (MMR) and Varicella Virus Vaccine

Salicylate use should be avoided for 6 weeks after vaccination due to the increased risk of Reyes Syndrome which can occur in children. Reyes Syndrome causes confusion, brain swelling, and liver damage.

Alternative Medications

There are other drugs available to treat ulcerative colitis. Speak to your doctor to discuss other medications.

Aminosalicylates

Lialda is an aminosalicylate, but other aminosalicylates can be used in the treatment and maintenance of mild to moderate ulcerative colitis. These medications work to decrease inflammation in the colon.

• sulfasalazine (Azulfidine), olsalazine (Dipentum) and balsalazide (Colazal)

Corticosteroids

Corticosteroids can be used in the treatment of moderate to severely active ulcerative colitis. They work by suppressing the immune system which decreases systemic inflammation. Due to short and long-term side effects of this medication, it should only be used in active flare-ups and not as maintenance.

• budesonide (Uceris), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisone (Rayos)

Immunomodulators

These drugs work to control and suppress the body’s immune system so that it cannot cause inflammation. These medications can take several months to become effective and are often used in conjunction with aminosalicylates or corticosteroids.

• azathioprine (Azasan), 6-mercaptopurine (6-MP), cyclosporine (Sandimmune), tacrolimus (Protopic)

Biologic Therapies

Biologics are reserved for the treatment of people with moderate to severe ulcerative colitis. They work by providing antibodies that stop the body from causing inflammation.

• adalimumab (Humira), infliximab (Inflectra, Remicade, Renflexis), golimumab (Simponi), vedolizumab (Entyvio)

Targeted Synthetic Small Molecules

These drugs work to reduce inflammation by targeting the immune system. They are used in patients with moderate to severely active disease.

• ozanimod (Zeposia), tofacitinib (Xeljanz), upadacitinib (Rinvoq)

Frequently Asked Questions