Olsalazine Sodium

 Action 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.

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

 Contraindications Hypersensitivity to salicylates or any product component.

 Route/Dosage

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

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache; fatigue; drowsiness; lethargy; depression. DERM: Rash; itching. GI: Diarrhea; abdominal pain, cramps; nausea; dyspepsia; bloating; anorexia. OTHER: Arthralgia; upper respiratory infection.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Renal impairment: Patients with history of renal disease or dysfunction may have worsening of renal function.

 Administration/Storage

• Administer with meals.
• Store at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Assess baseline vital signs, weight, BUN, creatinine, ALT, and AST.
• Monitor elimination patterns, color, and consistency of stools.
• Assess for rashes, respiratory difficulty, abdominal pain, vomiting, diarrhea, abdominal distention, or lethargy, and notify physician of any problems.

 Patient/Family Education

• Caution patient to notify physician 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 > 1 dose is missed, tell patient to notify physician.