ZALDYON- mesalamine tablet, delayed release
Cadila Healthcare Limited
Limitations of Use:
Safety and effectiveness of ZALDYON beyond 6 weeks have not been established.
2.1 Important Administration Instructions
- Do not substitute one ZALDYON 800 mg tablet for two mesalamine delayed-release 400 mg oral products [see Clinical Pharmacology (12.3)].
- Evaluate renal function prior to initiation of ZALDYON.
- Take ZALDYON tablets on an empty stomach, at least 1 hour before and 2 hours after a meal [see Clinical Pharmacology (12.3)].
- Swallow ZALDYON tablets whole. Do not cut, break or chew the tablets.
- Intact, partially intact, and/or tablet shells have been reported in the stool; Instruct patients to contact their physician if this occurs repeatedly.
- Protect ZALDYON tablets from moisture.
ZALDYON in adults is 1600 mg (two 800 mg tablets) three times daily (total daily dosage of 4.8 grams) for a duration of 6 weeks.
ZALDYON is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of ZALDYON [see Warnings and Precautions (5.3), Adverse Reactions (6.2), and Description (11)].
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients taking products such as ZALDYON that contain or are converted to mesalamine [see Adverse Reactions (6.2)].
Evaluate renal function prior to initiation of ZALDYON and periodically while on therapy. Evaluate the risks and benefits of using ZALDYON in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs [see Drug Interactions (7.1), Use in Specific Populations (8.6) and Nonclinical Toxicology (13.2)].
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Exacerbation of the symptoms of colitis has been reported in 2.3% of ZALDYON-treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of ZALDYON as well as other mesalamine products. Symptoms usually abate when ZALDYON are discontinued.
As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue ZALDYON if an alternative etiology for the signs or symptoms cannot be established.
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering ZALDYON tablets to patients with liver impairment.
- Renal Impairment [see Warnings and Precautions (5.1)]
- Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2)]
- Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
- Hepatic Failure [see Warnings and Precautions (5.4)]
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.
ZALDYON has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing ZALDYON 4.8 grams per day with mesalamine-delayed release tablets 2.4 grams per day in patients with mildly to moderately active ulcerative colitis. In these studies, 727 patients were dosed with ZALDYON tablets and 732 patients were dosed with mesalamine delayed-release tablets, 400 mg.
The most common reactions reported in the ZALDYON group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse reactions that occurred in the three studies. The most common reactions in patients with moderately active ulcerative colitis (602 patients dosed with ZALDYON and 618 patients dosed with the mesalamine delayed-release tablet, 400 mg) were the same as all treated patients.
Discontinuations due to adverse reactions occurred in 3.9% of patients in the ZALDYON group and in 4.2% of patients in the mesalamine delayed-release tablet, 400 mg comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.
Serious adverse reactions occurred in 0.8% of patients in the ZALDYON group and in 1.8% of patients in the mesalamine delayed-release tablet, 400 mg comparator group. The majority involved the gastrointestinal system.
N = number of patients within specified treatment group
Percent = percentage of patients in category and treatment group
|Adverse Reaction||Mesalamine delayed-release 2.4 grams per day (400 mg Tablet) (N = 732)||ZALDYON 4.8 grams per day (800 mg Tablet) (N = 727)|
|Headache||4.9 %||4.7 %|
|Nausea||2.9 %||2.8 %|
|Nasopharyngitis||1.4 %||2.5 %|
|Abdominal pain||2.3 %||2.3 %|
|Diarrhea||1.9 %||1.7 %|
|Dyspepsia||0.8 %||1.7 %|
|Vomiting||1.6 %||1.4 %|
|Flatulence||0.7 %||1.2 %|
|Influenza||1.2 %||1 %|
|Pyrexia||1.2 %||0.7 %|
|Cough||1.4 %||0.3 %|
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