Prescription Required
Description
Indications
Lialda (mesalamine) is an aminosalicylate indicated for:
- Induction and maintenance of remission in adults with mildly to moderately active ulcerative colitis
- Treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg(about 52 pounds)
Aminosalicylates are compounds that contain 5-aminosalicylic acid (also known as 5-ASA, similar to aspirin) and reduce inflammation in the lining of the intestine.
Dosage and Administration
The following information is a general overview and should not replace the guidance of a healthcare provider.
Recommended Dosage in Adults
For the induction of remission in adult patients with mildly to moderately active ulcerative colitis, the recommended dosage is:
- 4 g to 4.8 g (two to four 1.2-g tablets) once daily .
For maintenance of remission, the recommended dosage is:
- 4 g (two 1.2-g tablets) once daily .
Recommended Dosage in Pediatric Patients:
| Once-daily Lialda Dosage | ||
| Weight of Pediatric Patient | Week 0 to Week 8 | After Week 8 |
| 24 kg to 35 kg
(52 to 77 pounds) |
2.4 g
(two 1.2-g tablets) |
1.2 g
(one 1.2-g tablet) |
| Greater than 35 kg to 50 kg
(77 to 110 pounds) |
3.6 g
(three 1.2-g tablets) |
2.4 g
(two 1.2-g tablets) |
| Greater than 50 kg
(110 pounds) |
4.8 g
(four 1.2-g tablets) |
2.4 g
(two 1.2-g tablets) |
Administration Instructions:
- Swallow Lialda tablets whole; do not split or crush.
- Administer Lialda tablets with food .
- Drink an adequate amount of fluids while taking Lialda
Side Effects
The common side effects of Lialda can vary depending on the age group being treated. The most common adverse reactions reported for adults and pediatric patients are as follows:
Adults (greater than/equal to 2%):
- Headache
- Flatulence
- Abnormal liver function test
- Abdominal pain
- Diarrhea
Pediatric patients (greater than/equal to 5%):
- Abdominal pain
- Upper respiratory tract infection
- Vomiting
- Anemia
- Headache
- Viral infection
This is not a complete list of possible side effects associated with Lialda. If you experience any side effects while taking Lialda, it is recommended to contact your healthcare provider.
Warnings and Precautions
Lialda has the potential to decrease kidney (renal) function, especially if you have known kidney impairment or are taking drugs that can damage your kidneys. Therefore, periodic monitoring of your kidney function should occur while you are taking Lialda. Your healthcare provider will order appropriate blood tests and any other tests needed to monitor your kidney function.
Mesalamine, the active ingredient in Lialda, has been linked to a condition called acute intolerance syndrome. This syndrome can be challenging to distinguish from a flare-up of ulcerative colitis. Symptoms of this syndrome include cramping, sudden abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash.
Hypersensitivity reactions have been reported in patients taking sulfasalazine, a type of anti-inflammatory medication. As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, affecting the heart, kidneys, liver, lungs, and blood.
In patients with pre-existing liver disease who have taken mesalamine, there have been reports of liver failure. Therefore, the risks and benefits of Lialda in patients with known liver impairment should be carefully considered prior to its use.
Severe cutaneous (relating to the skin) adverse reactions may be associated with Lialda, and patients should stop taking Lialda and report any such reactions to their healthcare provider at first appearance.
Patients with conditions that cause obstruction in the upper gastrointestinal tract, such as pyloric stenosis, should avoid using Lialda. This is because obstruction can delay the release of mesalamine in the colon.
Individuals with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe reactions to sunlight while taking Lialda. These patients should avoid sun exposure, wear protective clothing, and use broad-spectrum sunscreen when outdoors.
The use of mesalamine has been associated with cases of kidney stones, and mesalamine-containing stones are undetectable by standard radiology testing, such as CT. Therefore, it is essential to adequately hydrate while taking Lialda.
Lialda may lead to elevated lab test results when measuring urinary normetanephrine, a substance excreted in the urine. Alternative testing methods should be considered if this substance requires measurement while taking Lialda.
Drug Form and Strength
This medication is available as a delayed-release tablet.
Tablet strength: 1.2 g
