bal-SAL-a-zide

Therapeutic Classification: gastrointestinal anti-inflammatories

• Mild-to-moderately active ulcerative colitis.

• Drug is metabolized in the colon to mesalamine (5-aminosalicylic acid), which is a local anti-inflammatory.

• Reduction in the symptoms of ulcerative colitis.

Absorption: Absorption is low and variable; drug is delivered intact to the colon.

Distribution: Mostly delivered intact to the colon; remainder of distribution unknown.

Protein Binding: ≥99%.

Metabolism/Excretion: Following delivery to the colon, bacteria break balsalazide down into mesalamine (5-aminosalicylic acid) and an inactive metabolite; mostly excreted in feces.

Half-life: Mesalamine: 12 hr (range 2–15 hr).

(decreased symptoms)

Contraindicated in:

• Hypersensitivity to salicylates or other metabolites.

Use Cautiously in:

• Pyloric stenosis (may have prolonged gastric retention of capsules)
• Renal or hepatic impairment
• Atopic dermatitis or atopic eczema (↑ risk of photosensitivity)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), photosensitivity, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

GI: abdominal pain, diarrhea, HEPATOTOXICITY.

GU: interstitial nephritis, nephrolithiasis, renal impairment.

Misc: acute intolerance syndrome, hypersensitivity reactions.

Drug-Drug:

• May ↑ myelosuppressive effects of mercaptopurine or azathioprine; avoid concurrent use, if possible.
• Concurrent use with NSAIDs may ↑ risk of nephrotoxicity.

• PO (Adults): 2.25 g 3 times daily for 8–12 wk.
• PO (Children 5–17 yrs): 2.25 g 3 times daily for up to 8 wk or 750 mg 3 times daily for up to 8 wk.

(Generic available)

• Capsules: 750 mg;

• Assess abdominal pain and frequency, quantity, and consistency of stools at the beginning of and during therapy.
• Monitor for signs and symptoms of mesalamine-induced intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) during therapy. Monitor for worsening of these symptoms during therapy. If acute intolerance syndrome is suspected, discontinue therapy promptly.
• Monitor for signs and symptoms of hypersensitivity reactions (myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, hematologic abnormalities) during therapy. If not alternative etiology, discontinue balsalazide.
• Assess patient for allergy to salicylates.

• Assess renal function before starting and periodically during therapy. Discontinue therapy if renal function declines.
  • May cause ↑ AST, ALT, serum alkaline phosphatase, gamma glutamyl transferase (GGT), LDH, and bilirubin.

• Do not confuse Colazal with Clozaril.
• PO: Administer capsules three times a day without regard to food. DNC: Swallow capsules whole; do not cut, break, crush or chew capsules.
  • Capsules may be opened and sprinkled on 10 mL of applesauce and taken immediately; do not store mixture. Mixture may be chewed. Color of powder inside of capsules may range from yellow to orange. Teeth or tongue staining may occur when powder is sprinkled on applesauce and swallowed.

• Instruct patient to take balsalazide as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose.
• Advise patient to drink plenty of fluids during therapy.
• Advise patient to notify health care professional if jaundice, skin rash, difficulty breathing, or hives occur.
• Advise patient to avoid sun exposure and wear protective clothing and sunscreen to prevent photosensitivity reactions.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor breastfed infants for diarrhea.
• Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.

• Decrease in diarrhea and abdominal pain in patients with ulcerative colitis.

Colazal, Giazo

NDC Code^*

• 0054- West-Ward Pharmaceuticals Corp.
  • 0054-0079- Balsalazide Disodium
    • 0054-0079-28- 280 CAPSULE in 1 BOTTLE (0054-0079-28)

• 42291- AvKARE, Inc.
  • 42291-157- Balsalazide Disodium
    • 42291-157-28- 280 CAPSULE in 1 BOTTLE (42291-157-28)

• 50268- AvPAK
  • 50268-102- Balsalazide Disodium
    • 50268-102-13- 30 BLISTER PACK in 1 BOX (50268-102-13) > 1 CAPSULE in 1 BLISTER PACK (50268-102-11)

• 60429- GSMS, Incorporated
  • 60429-952- Balsalazide Disodium
    • 60429-952-28- 280 CAPSULE in 1 BOTTLE (60429-952-28)

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-0- 10 BLISTER PACK in 1 CARTON (60505-2575-0) > 10 CAPSULE in 1 BLISTER PACK

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-3- 30 CAPSULE in 1 BOTTLE (60505-2575-3)

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-4- 350 CAPSULE in 1 BOTTLE (60505-2575-4)

• 60505- Apotex Corp.
  • 60505-2575- Balsalazide Disodium
    • 60505-2575-7- 280 CAPSULE in 1 BOTTLE (60505-2575-7)

• 65649- Salix Pharmaceuticals, Inc
  • 65649-101- Colazal
    • 65649-101-02- 280 CAPSULE in 1 BOTTLE (65649-101-02)

• 65649- Salix Pharmaceuticals, Inc
  • 65649-102- GIAZO
    • 65649-102-02- 180 TABLET, FILM COATED in 1 BOTTLE (65649-102-02)

• 68682- Oceanside Pharmaceuticals
  • 68682-750- balsalazide disodium
    • 68682-750-02- 280 CAPSULE in 1 BOTTLE (68682-750-02)