balsalazide disodium

Action

Metabolized in colon to mesalamine and then to 5-aminosalicylic acid, both of which are thought to exert local anti-inflammatory effect by inhibiting prostaglandin and acid metabolites.

Availability

Capsules: 750 mg

Indications and dosages

➣ Mildly to moderately active ulcerative colitis

Adults: Usual dosage, three 750-mg capsules P.O. t.i.d. (6.75 g daily) for up to 8 weeks; some patients may require 12 weeks

Children ages 5 to 17: Usual dosage, either three 750-mg capsules P.O. t.i.d. (6.75 g daily) for up to 8 weeks, or one 750-mg capsule P.O. t.i.d. (2.25 g daily) for up to 8 weeks

Contraindications

• Hypersensitivity to balsalazide, salicylates, or mesalamine

Precautions

Use cautiously in:

• renal impairment

• pyloric stenosis

• breastfeeding patients

• children younger than age 5 (safety and efficacy not established).

Administration

• Advise patient to swallow capsules whole, either always with or always without food.

• For those patients who can't swallow capsules whole, carefully open capsules and sprinkle contents on applesauce and have patient swallow contents immediately without chewing.

Adverse reactions

CNS: headache, insomnia, dizziness, anxiety, confusion, agitation, coma

EENT: blurred vision, eye irritation, tinnitus, earache, epistaxis, sinusitis, sore throat, nasopharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, oral blisters, oral candidiasis,

GI hemorrhage

GU: urinary tract infection

Musculoskeletal: arthralgia; myalgia; bone, back, neck, or limb pain

Respiratory: cough, upper respiratory tract infection

Skin: erythema

Other: generalized pain

Interactions

Drug-drug. Oral antibiotics: interference with balsalazide action

Patient monitoring

• Assess character and frequency of stools.

• Monitor CBC and liver and kidney function test results.

Patient teaching

• Instruct patient to take drug only as directed.

• Instruct patient to carefully open capsules and sprinkle contents on applesauce and swallow contents immediately without chewing if patient can't swallow capsules whole.

• Tell patient that teeth and tongue staining may occur when drug is taken by sprinkling on applesauce.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.