IMPORTANT SAFETY INFORMATION
Patients with known hypersensitivity to salicylates, aminosalicylates, or any of the ingredients of ASACOL HD.
WARNINGS AND PRECAUTIONS
Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and rarely, renal failure, has been reported.
Evaluate renal function prior to initiation of treatment and periodically while on therapy. Evaluate the risks and benefits of using ASACOL HD
in patients with known renal impairment or a history of renal disease and/or those taking concomitant nephrotoxic drugs.
Mesalamine-induced acute intolerance syndrome
Monitor patients for worsening of cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritus,
conjunctivitis, and rash and promptly discontinue ASACOL HD if acute intolerance syndrome is suspected. Symptoms usually subside when ASACOL HD
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 ASACOL HD if a hypersensitivity reaction is suspected.
Hepatic failure has been reported in patients with preexisting liver disease who have been administered mesalamine.
Evaluate the risks and benefits in patients with known liver impairment.
Severe cutaneous adverse reactions
Discontinue ASACOL HD at the first appearance of signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity,
and consider further evaluation.
Advise patients with preexisting 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 hydration during treatment.
ASACOL HD contains iron oxide. Consider the iron content of ASACOL HD in patients taking iron supplementation and those at risk of iron overload.
Interference with Laboratory Tests
Use of mesalamine may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography
with electrochemical detection. Consider an alternative selective assay for normetanephrine.
In clinical trials, the most common adverse reactions (observed in ≥ 2% of patients) were headache, nausea, nasopharyngitis, abdominal pain, and worsening of UC.
The 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.
The concurrent use of mesalamine with azathioprine, 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 ASACOL HD.
ASACOL® HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults.
The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.
full Prescribing Information
for ASACOL HD.