Dipentum

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders

Dipentum Generic Name & Formulations

General Description

Olsalazine sodium 250mg; caps.

Pharmacological Class

Salicylate.

How Supplied

Caps—100

Manufacturer

Generic Availability

NO

Mechanism of Action

The mechanism of action of olsalazine is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells.

Dipentum Indications

Indications

Maintenance of remission in ulcerative colitis in patients intolerant of sulfasalazine.

Dipentum Dosage and Administration

Adult

500mg twice a day with meals.

Children

Not established.

Dipentum Contraindications

Not Applicable

Dipentum Boxed Warnings

Not Applicable

Dipentum Warnings/Precautions

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. 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: not recommended.

Dipentum Pharmacokinetics

Absorption

Maximum serum concentrations: ~1 hour.

Distribution

Plasma protein bound: >99%.

Metabolism

Hepatic. 

Elimination

Renal. Half-life: ~0.9 hour.

Dipentum Interactions

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; monitor CBCs, platelets if concomitant use is unavoidable. May cause elevated test results when measuring urinary normetanephrine; consider alternative assay. Increased risk of bleeding (eg, hematomas) following neuraxial anesthesia with low molecular weight heparins or heparinoids. Increased prothrombin time with warfarin; monitor and adjust dose. Increased risk of Reye’s syndrome with varicella vaccine; avoid for 6 weeks after varicella vaccine.

Dipentum Adverse Reactions

Adverse Reactions

Diarrhea, abdominal pain, rash, pruritus; acute intolerance syndrome (cramping, bloody diarrhea, fever, headache, rash), renal impairment, hypersensitivity reactions, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).

Dipentum Clinical Trials

See Literature

Dipentum Note

Not Applicable

Dipentum Patient Counseling

See Literature