Lialda

The active ingredient in Lialda is mesalamine. Mesalamine is also known as 5-aminosalicylic acid or 5-ASA. It is unclear how exactly mesalamine works but it is thought to have anti-inflammatory properties that help to decrease the inflammation seen in the colon in patients with mild to moderately active ulcerative colitis. Treatment of the inflammation will improve other symptoms of ulcerative colitis such as rectal bleeding, diarrhea, and stomach pain. Once induction of remission is achieved, Lialda may be continued at the discretion of your healthcare provider to maintain that remission. Lialda has no indication for use in inflammatory bowel syndrome (IBS) or Crohn’s disease.

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 Lialda. However, the following is a synopsis of the general guidelines for the use of Lialda:

• Lialda should be used exactly as prescribed by your healthcare provider.
• Lialda is typically taken by mouth once a day with food and a full glass of water. The number of tablets you will have to take depends on your age and whether the goal of treatment is treating a flare or maintaining remission.
• Take the tablets whole. Do not crush or split the tablets. Doing so will alter how the Lialda tablets work in your body and may make them less effective.
• Lialda can increase your sensitivity to the sun, especially if you have certain skin conditions like eczema or atopic dermatitis. Make sure to use a broad-spectrum sunscreen with at least SPF 30 and wear protective clothing to reduce the risk of sunburn.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Lialda seen in clinical trials include:

• Headache
• Flatulence
• Stomach or abdominal pain
• Diarrhea
• Abnormal liver function tests

In pediatric patients, they may experience the above and additional side effects such as:

• Nausea and vomiting
• An increased risk of upper respiratory tract or viral infections
• Anemia

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

• Signs of an anaphylactic reaction such as trouble breathing, hives, or swelling of the face, eyes, or tongue.
• Signs of inflammation of different parts of the heart (myocarditis, pericarditis) such as chest pain, heart palpitations, shortness of breath, swelling of the legs, feet, arms, or hands, or fatigue.
• Signs of kidney damage such as decreased urination, swelling of the legs, feet, arms, or hands, fatigue, or shortness of breath.
• Signs of kidney stones such as severe lower back pain, urine that is bloody or cloudy, stomach pain, or nausea and vomiting.
• Signs of Mesalamine-Induced Acute Intolerance Syndrome such as stomach pain, cramping, and bloody diarrhea. Other signs also include fever, headache, and rash.
• Signs of liver problems such as jaundice or yellowing of the eyes and skin, right-sided upper abdominal pain, loss of appetite, or dark urine.
• Signs of pancreatitis or inflammation of the pancreas such as severe stomach pain that radiates to the back or chest, nausea and vomiting, fever, bloating, or a tender stomach.
• Signs of a serious skin reaction such as a widespread skin rash with fever, blisters, peeling of the skin, or a sunburn-like reaction. These symptoms may be the first signs of a life-threatening skin reaction like Stevens-Johnson Syndrome.

These are not all of the possible side effects of Lialda. 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 Lialda, 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, including if you have:

• Kidney problems or renal impairment
• Liver disease
• A history of an allergic reaction to sulfasalazine
• Pyloric stenosis or a block in the upper GI tract
• Eczema or atopic dermatitis

Do not use Lialda if you have:

• An allergy to salicylates or aminosalicylates
• An allergy to mesalamine or any of the inactive ingredients in Lialda

Lialda will start to work against the inflammation right after the first dose. However, it may take several weeks of consistent use to see the full benefit.

When Lialda 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:

• Azathioprine
• 6-mercaptopurine
• NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen, naproxen, aspirin, diclofenac, celecoxib, and indomethacin

Lialda is available as delayed-release tablets in the following strengths:

• 1.2 g

Lialda should be stored at room temperature, away from light and extreme temperatures, and out of reach of children.

Lialda is manufactured by the pharmaceutical company Takeda Pharmaceuticals.

Yes, a generic version of the brand name Lialda is available.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Lialda.

It is unknown if Lialda can cause harm to your unborn child. 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.

Lialda can pass into the breast milk and it is unknown if it may cause harm to the breastfeeding infant. 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.