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mesalamine
Overview
What is Lialda?
Each LIALDA delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is:
Molecular formula: C
H
NO
Molecular weight: 153.14
The tablet is coated with a pH dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine.
The inactive ingredients of LIALDA are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide and polyethylene glycol 6000.
What does Lialda look like?
What are the available doses of Lialda?
Delayed-Release Tablets: 1.2 g (
)
What should I talk to my health care provider before I take Lialda?
How should I use Lialda?
LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is two to four 1.2 g tablets taken once daily with a meal for a total daily dose of 2.4 g or 4.8 g. The recommended dosage for the maintenance of remission is two 1.2 g tablets taken once daily with a meal for a total daily dose of 2.4 g.
What interacts with Lialda?
Sorry No Records found
What are the warnings of Lialda?
Sorry No Records found
What are the precautions of Lialda?
Sorry No Records found
What are the side effects of Lialda?
Sorry No records found
What should I look out for while using Lialda?
LIALDA is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of LIALDA
,
,
What might happen if I take too much Lialda?
LIALDA is an aminosalicylate, and symptoms of salicylate toxicity may include tinnitus, vertigo, headache, confusion, drowsiness, sweating, seizures, hyperventilation, dyspnea, vomiting, and diarrhea. Severe intoxication may lead to disruption of electrolyte balance and blood-pH, hyperthermia, dehydration, and end organ damage.
There is no specific known antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.
How should I store and handle Lialda?
QUDEXY XR (topiramate) extended-release capsules should be stored in a tightly-closed container at 20 to 25°C (68 to 77°F). Excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.LIALDA is available as red-brown ellipsoidal film coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476.NDC 54092-476-12 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets.NDC single dose pack with 1 tablet as Store at room temperature 15 C to 25 C (59 F to 77 F); excursions permitted to 30 C (86 F).See USP Controlled Room Temperature.LIALDA is available as red-brown ellipsoidal film coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476.NDC 54092-476-12 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets.NDC single dose pack with 1 tablet as Store at room temperature 15 C to 25 C (59 F to 77 F); excursions permitted to 30 C (86 F).See USP Controlled Room Temperature.LIALDA is available as red-brown ellipsoidal film coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476.NDC 54092-476-12 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets.NDC single dose pack with 1 tablet as Store at room temperature 15 C to 25 C (59 F to 77 F); excursions permitted to 30 C (86 F).See USP Controlled Room Temperature.LIALDA is available as red-brown ellipsoidal film coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476.NDC 54092-476-12 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets.NDC single dose pack with 1 tablet as Store at room temperature 15 C to 25 C (59 F to 77 F); excursions permitted to 30 C (86 F).See USP Controlled Room Temperature.LIALDA is available as red-brown ellipsoidal film coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476.NDC 54092-476-12 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets.NDC single dose pack with 1 tablet as Store at room temperature 15 C to 25 C (59 F to 77 F); excursions permitted to 30 C (86 F).See USP Controlled Room Temperature.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of mesalamine is not fully understood, but appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Mesalamine has the potential to inhibit the activation of nuclear factor kappa B (NFκB) and consequently the production of key pro-inflammatory cytokines. It has been proposed that reduced expression of PPARγ nuclear receptors (γ-form of peroxisome proliferator-activated receptors) may be implicated in ulcerative colitis. There is evidence that mesalamine produces pharmacodynamic effects through direct activation of PPARγ receptors in the colonic/rectal epithelium.
Non-Clinical Toxicology
LIALDA is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of LIALDA , ,Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA (tretinoin cream) 0.02% because they may increase irritation with RENOVA (tretinoin cream) 0.02%.
RENOVA (tretinoin cream) 0.02% should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine.
It is recommended that patients have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy. Exercise caution when using LIALDA in patients with known renal dysfunction or a history of renal disease.
In animal studies, the kidney was the principal organ for toxicity.
The most serious adverse reactions seen in Lialda clinical trials or with other products that contain or are metabolized to mesalamine are:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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