BALSALAZIDE
| BALSALAZIDE (bal-sal'a-zide) Colazal Classifications: mucous membrane agent; antiinflammatory agent; Therapeutic: antiinflammatory agent Prototype: Mesalamine (5-ASA) Pregnancy Category: B |
Availability
750 mg capsules
Action
A prodrug of mesalamine that remains intact until it reaches the lumen of the colon. Thought to decrease inflammation of the mucous lining of the colon by blocking cyclooxygenase and inhibiting prostaglandin synthesis in the lining of the colon.
Therapeutic Effect
An antiinflammatory agent and a prodrug of 5-ASA.
Uses
Treatment of mild to moderate active ulcerative colitis.
Contraindications
Prior hypersensitivity to salicylates, balsalazide.
Cautious Use
Hypersensitivity to mesalamine, sulfasalazine, olsalazine, salicylate. Allergic response to any medications; hepatic or renal impairment; pregnancy (category B), lactation; pyloric stenosis. Safety and efficacy in children are not established.
Route & Dosage
| Ulcerative Colitis Adult: PO 2250 mg (3 times 750 mg) t.i.d. for 8–12 wk |
Administration
Oral- Give in a consistent manner with respect to food intake (i.e., either always with or always without food).
- Store at room temperature, preferably between 15°–30° C (59°–86° F).
Adverse Effects (≥1%)
Body as a Whole: Arthralgia, fatigue, fever, pain, back pain. CNS: Headache, insomnia. GI: Abdominal pain, nausea, diarrhea, vomiting, rectal bleeding, flatulence, dyspepsia, coughing, anorexia. Respiratory: Rhinitis, pharyngitis.Interactions
No clinically significant interactions established.Pharmacokinetics
Absorption: Low and variable absorption from the colon. Distribution: >99% protein bound. Metabolism: Metabolized in colon by bacterial azoreductases to release 5-aminosalicylic acid and 4-aminobenzoyl-beta-alanine. Elimination: 25% of metabolites excreted in urine.Nursing Implications
Assessment & Drug Effects
- Monitor for S&S of myelosuppression in patients also receiving azathioprine.
- Lab tests: Closely monitor CBS with concomitant azathioprine therapy; monitor renal and liver functions when used with other aminosalicylates.
Patient & Family Education
- Report worsening of S&S of colitis to physician (e.g., diarrhea, abdominal pain, fever, rectal bleeding).
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug