Asacol Hd

  • Colorectal disorders

Asacol Hd Generic Name & Formulations

General Description

Mesalamine 800mg; delayed release tabs; contains iron 4.9mg/tab.

Pharmacological Class


How Supplied



Generic Availability


Asacol Hd Indications


Moderately active ulcerative colitis.

Limitations of Use

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

Asacol Hd Dosage and Administration


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


Not established.

Asacol Hd Contraindications

Not Applicable

Asacol Hd Boxed Warnings

Not Applicable

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 Pharmacokinetics




Renal (primary), fecal.

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.

Asacol Hd Adverse Reactions

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).

Asacol Hd Clinical Trials

See Literature

Asacol Hd Note

Not Applicable

Asacol Hd Patient Counseling

See Literature