Rx Item-Mesalamine 1.2Gm Generic Lialda DR Tab 120 By Zydus Pharma

LIALDA- mesalamine tablet, delayed release
Shire US Manufacturing Inc.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS



The red-brown ellipsoidal delayed-release tablet containing 1.2 g mesalamine is debossed on one side and imprinted with S476.

4 CONTRAINDICATIONS

LIALDA is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of LIALDA [see Warnings and Precautions (5.3), Description (11), Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Renal Impairment
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. [See Drug Interactions (7.1) and Nonclinical Toxicology (13.2)]

5.2 Mesalamine-Induced Acute Intolerance Syndrome
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. 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. If acute intolerance syndrome is suspected, promptly discontinue treatment with LIALDA.

5.3 Hypersensitivity Reactions
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. Caution should be taken in prescribing this medicine to patients with conditions predisposing them to the development of myocarditis or pericarditis.

RX ITEM-Mesalamine 1.2Gm Generic Lialda
NDC 43386-0510-87 UPC/GTIN No.3-43386-51087-0 Mfg.Part No.51087

Mesalamine 1.2Gm Generic Lialda DR Tab 1
BRAND: MESALAMINE NDC: 68382-0711-19,68382071119 UPC: 3-43386-51087-0,343386510870 Lupin Pharma

MESALAMINE RECTAL ENEMA 4
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