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Trade Names:
Dipentum
- Capsules 250 mg

Mechanism of Action

Pharmacology

Bioconverted to 5-aminosalicylic acid (mesalamine) in colon. Although mechanism of action is unknown, it probably reduces inflammation of colon topically by preventing production of substances involved in inflammatory process such as arachidonic acid.

Pharmacokinetics

Absorption

Little is systematically absorbed. T _max is approximately 1 hr. Steady state is 2 to 3 wk (metabolite olsalazine-s).

Distribution

Once the drug metabolized to 5-aminosalicylic (5-ASA), the drug is slowly absorbed from the colon resulting in high concentration levels. More than 99% of olsalazine and olsalazine-s is protein bound. 74% of 5-ASA is protein bound.

Metabolism

0.1% of dose is metabolized in liver to olsalazine-o-sulfate metabolite. The remainder reaches the colon and is rapidly converted to 5-ASA by colonic bacteria.

Elimination

Less than 1% is recovered in the urine. A small amount is recovered in the feces. The t _½ (serum) is 0.9 hr for olsalazine and 7 days for olsalazine-s.

Indications and Usage

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

Contraindications

Hypersensitivity to salicylates or any product component.

Dosage and Administration

PO 500 mg bid (2 capsules) (total of 1 g/day).

Storage/Stability

Store at room temperature.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache; fatigue; drowsiness; lethargy; depression.

Dermatologic

Rash; itching.

GI

Diarrhea; abdominal pain, cramps; nausea; dyspepsia; bloating; anorexia.

Miscellaneous

Arthralgia; upper respiratory infection.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Renal Function

Patients with history of renal disease or dysfunction may have worsening of renal function.

Patient Information

• Caution patient to notify health care provider of rashes, respiratory difficulty, lethargy, muscle weakness, vomiting, diarrhea or abdominal distention, or worsening of abdominal pain.
• Advise patient not to take double doses if one is missed. If more than 1 dose is missed, tell patient to notify health care provider.