Colorectal disorders:

Indications for: DELZICOL

Mildly to moderately active ulcerative colitis (UC) in patients ≥5 years of age. Maintenance of remission of UC in adults.

Adult Dosage:

Swallow caps whole; if unable to swallow, may open and swallow contents (four 100mg tabs). Treatment: 800mg 3 times daily for 6 weeks. Maintenance: 1.6g/day in 2–4 divided doses. Two Delzicol 400mg caps are not bioequivalent to one mesalamine 800mg del-rel tab.

Children Dosage:

<5yrs: not established. Give twice daily dosing for 6 weeks. ≥5yrs (17–32kg): 36–71mg/kg/day, up to max 1.2g/day (800mg in the AM + 400mg in the afternoon); (33–53kg): 37–61mg/kg/day, up to max 2g/day (1200mg in the AM + 800mg in the afternoon); (54–90kg): 27–44mg/kg/day, up to max 2.4g/day (1200mg in the AM + 1200mg in the afternoon).

DELZICOL Warnings/Precautions:

Sulfasalazine allergy. Discontinue if acute intolerance syndrome is suspected. Discontinue at the 1st signs/symptoms of severe cutaneous adverse reactions. Conditions predisposing to myocarditis or pericarditis. Atopic dermatitis or eczema: may have more severe photosensitivity reactions. Nephrolithiasis. Ensure adequate hydration. Consider iron content of Delzicol in those taking iron supplementation or at risk of iron overload. Renal or hepatic impairment. History of renal disease. Assess renal function prior to and periodically during therapy. Discontinue if renal function deteriorates while on therapy. Elderly (monitor CBCs, platelets). Pregnancy. Nursing mothers: monitor infants.

DELZICOL Classification:

Salicylate.

DELZICOL Interactions:

Increased toxicity with nephrotoxic drugs (eg, NSAIDs). Increased risk for blood disorders, bone marrow failure, and associated complications with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity. May cause elevated test results when measuring urinary normetanephrine; consider other alternative assay.

Adverse Reactions:

Eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, rash, dyspepsia, flu syndrome; acute intolerance syndrome, hypersensitivity reactions, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP). Pediatrics: also, nasopharyngitis, headache, sinusitis, cough, diarrhea, fatigue, pyrexia, increased lipase.

Metabolism:

Hepatic.

Drug Elimination:

Renal, fecal (minor).

Generic Drug Availability:

YES

How Supplied:

Caps—180