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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. The recommended dosage for the maintenance of remission is two 1.
The red-brown ellipsoidal delayed-release tablet containing 1. 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. In animal studies, the kidney was the principal organ for toxicity [See Drug Interactions 7.
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis.
Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to LIALDA tablets or to other compounds that contain or are converted to mesalamine. Mesalamine-induced cardiac hypersensitivity reactions myocarditis and pericarditis have been reported with LIALDA and other mesalamine medications.
Take caution in prescribing this medicine to patients with conditions predisposing them to the development of myocarditis or pericarditis. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of LIALDA, which would delay mesalamine release in the colon.
Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Consider an alternative, selective assay for normetanephrine. The most serious adverse reactions seen in LIALDA clinical trials or with other products that contain or are metabolized to mesalamine are:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
LIALDA has been evaluated in patients with ulcerative colitis in controlled and open-label trials. In two 8-week, placebo-controlled clinical trials involving patients with ulcerative colitis, received 2. The most frequent adverse reaction leading to discontinuation from LIALDA therapy was exacerbation of ulcerative colitis 0.
Gastrointestinal Disorders : abdominal distention, colitis, diarrhea, pancreatitis, rectal polyp, vomiting. General Disorders and Administrative Site Disorders : asthenia, face edema, fatigue, pyrexia. The dose evaluated in three studies of LIALDA given for the maintenance of remission in patients with ulcerative colitis was 1. One of these studies was a 6-month double-blind comparator study, while two were to month open-label studies.
Of the subjects in the all maintenance studies pooled, 1. The most common severe adverse reactions were gastrointestinal disorders; these were mainly symptoms associated with ulcerative colitis.
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Mesalamine Delayed-Release Tablets, USP
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