Balsalazide Disodium

Class and Category

Pharmacologic class: Salicylate

Therapeutic class: Anti-inflammatory

Indications and Dosages

To treat mildly to moderately active ulcerative colitis

CAPSULES

Adults. 2.25 g three times daily for up to 8 to 12 wk: Maximum: 6.75 g daily for 12 wk.

Children ages 5 to 17: 750 mg or 2.25 g three times daily for up to 8 wk.

TABLETS

Adults: 3.3 g twice daily for up to 8 wk.

Mechanism of Action

• After it has been metabolized to 5-ASA, balsalazide may reduce inflammation by inhibiting the enzyme cyclooxygenase and decreasing production of arachidonic acid metabolites, which may be increased in patients with inflammatory bowel disease.
• Cyclooxygenase is needed to form prostaglandin from arachidonic acid.
• Prostaglandin mediates inflammatory activity and produces signs and symptoms of inflammation. By inhibiting prostaglandin synthesis, balsalazide may reduce signs and symptoms of inflammation in inflammatory bowel disease.
• Balsalazide also interferes with leukotriene synthesis and inhibits the enzyme lipoxygenase. These substances are involved in the inflammatory response.

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Contraindications

Hypersensitivity to balsalazide, salicylates, or their components

Interactions

DRUGS

None reported

Adverse Reactions

CNS: Fatigue, fever, headache, insomnia

CV: Myocarditis, pericarditis, vasculitis

EENT: Dry mouth, nasopharyngitis, pharyngitis, rhinitis, stomatitis

GI: Abdominal cramps or pain, anorexia, cirrhosis, constipation, diarrhea, dyspepsia, elevated liver enzyme levels, exacerbation of colitis, flatulence, hepatotoxicity, jaundice, nausea, pancreatitis, vomiting

GU: Dysmenorrhea, interstitial nephritis, renal failure, UTI

MS: Arthralgia, myalgia

RESP: Alveolitis, cough, pleural effusion, pneumonia, respiratory tract infection

SKIN: Alopecia, pruritus

Other: Anaphylaxis, flu-like syndrome

Childbearing Considerations

PREGNANCY

• It is not known if drug can cause fetal harm.
• Use with caution only if benefit to mother outweighs potential risk to fetus.

LACTATION

• It is not known if drug is present in breast milk.
• Patient should check with prescriber before breastfeeding.

Nursing Considerations

WARNING Monitor patients who are sensitive to olsalazine or sulfasalazine for possible cross-sensitivity to balsalazide.

• Monitor patients with pyloric stenosis for decreased or delayed drug effects due to prolonged gastric retention of balsalazide capsules.
• Monitor patient for possible exacerbation of colitis symptoms.

PATIENT TEACHING

1. Inform patient that balsalazide is used to reduce bowel inflammation and pain in ulcerative colitis and to minimize recurring inflammation.
2. Instruct patient to swallow capsules whole, with a full glass of water, and not to chew or crush them.
3. Advise patient to notify prescriber of any other drugs he/she may be taking, including herbal products, nutritional supplements, and OTC drugs, because they may interact with balsalazide.
4. Instruct patient to notify prescriber immediately if colitis symptoms worsen.
5. Inform patient that she can expect some improvement in symptoms in 3 to 21 days but that optimal results may take up to 6 weeks of treatment.

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