Balsalazide Disodium

 Action Reduces inflammation of colon by preventing local production of substances involved in inflammatory process such as arachidonic acid.

 Indications Treatment of mildly to moderately active ulcerative colitis.

 Contraindications Hypersensitivity to salicylates or any of the components of balsalazide capsules or balsalazide metabolites.

 Route/Dosage

ADULTS: PO 2.25 g (ie, three 750 mg capsules) tid (ie, 6.75 g/day) for 8 wk; some patients may require up to 12 wk of treatment.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache; insomnia; dizziness. EENT: Rhinitis; pharyngitis; coughing; sinusitis. GI: Abdominal pain; nausea; vomiting; rectal bleeding; flatulence; dyspepsia; anorexia; frequent stools; dry mouth; cramps; constipation. GU: Urinary tract disorder. HEPA: Hepatotoxicity; jaundice; cholestatic jaundice; cirrhosis; hepatocellular damage. RESP: Respiratory disorder; infection. OTHER: Arthralgia; fatigue; fever; pain; back pain; myalgia; flu-like symptoms.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established. Colitis exacerbation: Some patients may develop symptoms of colitis.

 Administration/Storage

• Do not chew or crush. Instruct patient to swallow capsule whole.
• Give tid with a full glass of water.
• Store at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of pyloric stenosis.
• Monitor patient for GI, CNS, and musculoskeletal side effects and report to physician if noted and significant.
• Assess patient's colitis symptoms including the following: rectal bleeding, stool frequency and character, abdominal pain, and overall functional status.
• Store at controlled room temperature.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to not crush or chew medication and to swallow the capsule whole with a full glass of water.
• Advise patient that usual course of therapy is 8 to 12 wk.
• Advise patient to report worsening of colitis symptoms to physician.
• Advise patients to inform the health care provider if experiencing side effects such as headache, stomach pain, nausea, or diarrhea.
• Advise patients that follow-up visits and examinations may be required to monitor therapy; remind patients to keep appointments.