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Mesalamine ER

Class
Intestinal anti-inflammatory agents
Subclass
Aminosalicylates
Substance name
Mesalamine, mesalazine, 5-aminosalicylic acid, 5-ASA ER
Brand names
Apriso®, Pentasa®
Common formulations
Capsule
See also
Mesalamine DR (Lialda®, Delzicol®)
Mesalamine (Rowasa®, Canasa®)
Dosage and administration
Adults patients
Ulcerative colitis • Maintenance of remission
•
1,500 mg PO qAM
Ulcerative colitis • Mild-to-moderate, induction of remission
•
1,000 mg PO QID for up to 8 weeks
Indications for use
Labeled indications
Adults
•
Treatment of ulcerative colitis (maintenance of remission)
•
Treatment of ulcerative colitis (mild-to-moderate, induction of remission)
Safety risks
Contraindications
Hypersensitivity to mesalamine or its components or salicylates or aminosalicylates
Warnings and precautions
ALF
•
Use caution in patients with pre-existing liver disease.
Exacerbation of phenylketonuria
•
Use caution in patients with phenylketonuria, as extended-release mesalamine tablets contain phenylalanine.
Hypersensitivity reactions
•
Maintain a high level of suspicion, as mesalamine may cause hypersensitivity reactions involving internal organs, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Use caution in patients with a history of hypersensitivity to sulfasalazine.
Mesalamine-induced acute intolerance syndrome
•
Maintain a high level of suspicion, as mesalamine may cause acute intolerance syndrome, presented with symptoms such as cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash, that may be difficult to distinguish from an exacerbation of ulcerative colitis.
Minimal change disease, interstitial nephritis, renal failure
•
Maintain a high level of suspicion, as mesalamine has been associated with an increased risk for these adverse events. Assess renal function at baseline and periodically during treatment.
Nephrolithiasis
•
Maintain a high level of suspicion, as mesalamine has been associated with an increased risk of nephrolithiasis, including mesalamine-containing stones. Advise adequate fluid intake during treatment.
Photosensitivity of skin
•
Use caution in patients with pre-existing skin conditions, such as atopic dermatitis. Advise patients to avoid sun exposure, wear protective clothing, and apply sunscreen while outdoors.
Positive urine normetanephrine test
•
Maintain a high level of suspicion, as mesalamine has been reported to cause false-positive urine test results for normetanephrine by liquid chromatography with electrochemical detection due to the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid.
Severe cutaneous adverse reactions
•
Maintain a high level of suspicion, as mesalamine has been associated with an increased risk of severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, and acute generalized exanthematous pustulosis.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use with caution. Monitor renal function. Monitor for nephrotoxicity.
Renal replacement therapy
Continuous renal replacement
•
Use with caution. Monitor renal function. Monitor for nephrotoxicity.
Intermittent hemodialysis
•
Use with caution. Monitor renal function. Monitor for nephrotoxicity.
Peritoneal dialysis
•
Use with caution. Monitor renal function. Monitor for nephrotoxicity.
Hepatic impairment
Any severity
•
Use with caution. Monitor for hepatic failure.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if benefits outweigh potential risks. Mesalamine crosses the placenta.
Breastfeeding
Use only if benefits outweigh potential risks.
•
Monitor breastfed infants for diarrhea.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Headache
Common 1-10%
•
Cholestasis, nasopharyngitis, abdominal pain, dyspepsia, vomiting, diarrhea, epigastric pain, nausea, skin rash, tinnitus, vertigo, rectal bleeding, hair loss, lower abdominal pain, anemia, ↑ serum triglycerides, fatigue, ↑ serum transaminases, hematuria, arthralgia, dyspnea
Uncommon < 1%
•
↓ platelet count, ↑ platelet count, palpitations, abdominal distension, constipation, dysphagia, belching, fecal incontinence, gastrointestinal bleeding, mouth ulcers, malaise, fever, conjunctivitis, ↑ serum ALP, ↑ serum LDH, ↑ serum lipase, ↑ serum amylase, loss of appetite, ↑ thirst, myalgia, leg cramps, somnolence, insomnia, dizziness, asthenia, depression, urinary frequency, amenorrhea, breast pain, menorrhagia, photosensitivity of skin, erythema nodosum, skin dryness, itching, urticaria, sweating, ecchymosis, pericarditis, acute pancreatitis
Unknown frequency
•
Myocarditis, acute cholecystitis, gastritis, gastroenteritis, hepatic necrosis, acute liver failure, hepatitis, aplastic anemia, Guillain-Barré syndrome, nephrogenic diabetes insipidus, renal failure, interstitial nephritis, nephrolithiasis, minimal change disease, eosinophilic pneumonia, interstitial lung disease, pyoderma gangrenosum, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, acute generalized exanthematous pustulosis, intracranial hypertension, lupus-like symptoms, pericardial effusion, jaundice, agranulocytosis, peripheral neuropathy, transverse myelitis, pleuritis, oligozoospermia, psoriasiform rash, chest pain, pancytopenia, ↓ WBC count, angioedema, acne
Interactions
Drug(s)
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