IMPORTANT SAFETY INFORMATION
Patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL.
Warnings and Precautions
Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported with products such as DELZICOL that contain or are converted to mesalamine. Evaluate renal function prior to initiation of DELZICOL and periodically while on therapy. Evaluate the risks and benefits of using DELZICOL in patients with known renal impairment, a history of renal disease, or who are taking concomitant nephrotoxic drugs.
Mesalamine-Induced Acute Intolerance Syndrome
Monitor for worsening of the following symptoms: cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritis, conjunctivitis, and rash. Symptoms usually subside when DELZICOL is discontinued. Monitor for worsening of symptoms and promptly discontinue if acute intolerance syndrome is suspected.
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 and discontinue DELZICOL if a hypersensitivity reaction is suspected.
Hepatic failure has been reported in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits of using DELZICOL in patients with known liver impairment.
Advise patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
Mesalamine-containing stones are undetectable by standard radiography or computed tomography. Ensure adequate fluid intake during treatment with DELZICOL.
DELZICOL contains iron oxide. Consider the iron content of DELZICOL in patients taking iron supplementation and those at risk of iron overload.
Interference with Laboratory Tests
Use of DELZICOL may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative selective assay for normetanephrine.
The most common adverse reactions (incidence ≥ 5%) in adults were eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.
The most common adverse reactions (incidence ≥ 5%) in pediatric patients (5 to 17 years old) were nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, diarrhea, fatigue, pyrexia, and increased lipase.
Concurrent use of mesalamine with known nephrotoxic agents including, nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
Concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity may increase the risk for blood
disorders, bone marrow failure, and associated complications. Monitor blood tests, including complete blood cell counts and platelet counts if concomitant use cannot be avoided.
Geriatric use: A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) has been reported in subjects receiving mesalamine who are 65 years or older compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with DELZICOL.
DELZICOL is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older and for the maintenance of remission of UC in adults.
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