Colorectal disorders:

Indications for: ASACOL HD

Moderately active ulcerative colitis.

Limitations of Use:

Safety and effectiveness of Asacol HD beyond 6 weeks have not been established.

Adult Dosage:

Swallow whole; do not crush or chew. Treatment: 1600mg 3 times daily for 6 weeks.

Children Dosage:

Not established.

ASACOL HD 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 Asacol HD 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.

ASACOL HD Classification:

Salicylate.

ASACOL HD 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:

Headache, nausea, abdominal pain, diarrhea, nasopharyngitis, dyspepsia; renal impairment (eg, interstitial nephritis, minimal change disease, renal failure [rare]), hypersensitivity reactions (discontinue if occurs), severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).

Metabolism:

Hepatic.

Drug Elimination:

Renal (primary), fecal.

Generic Drug Availability:

YES

How Supplied:

Tabs—180