Based on in vitro studies, APRISO is not expected to inhibit the
metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19,
CYP2D6, or CYP3A4.
Because the dissolution of the coating of the granules in
APRISO capsules depends on pH, APRISO capsules should not be
co-administered with antacids.
APRISO is an aminosalicylate, and symptoms of salicylate toxicity
include hematemesis, tachypnea, hyperpnea, tinnitus, deafness, lethargy,
seizures, confusion, or dyspnea. Severe intoxication may lead to
electrolyte and blood pH imbalance and potentially to other organ (e.g.,
renal and liver) involvement. There is no specific antidote
for mesalamine overdose; however, conventional therapy for salicylate
toxicity may be beneficial in the event of acute overdosage. This
includes prevention of further gastrointestinal tract absorption by
emesis and, if necessary, by gastric lavage. Fluid and electrolyte
imbalance should be corrected by the administration of appropriate
intravenous therapy. Adequate renal function should be
maintained. APRISO is a pH-dependent delayed-release product
and this factor should be considered when treating a suspected
APRISO is contraindicated in patients with hypersensitivity to
salicylates or aminosalicylates or to any of the components of APRISO
- Sutherland LR, Martin F, Greer S, Robinson M, Greenberger N, Saibil F, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987;92(6):1894-1898.
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